Trial Outcomes & Findings for Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement (NCT NCT02805309)

Last Updated: 2021-07-21

Results Overview

The LLFDI is a validated patient-reported outcome questionnaire that measures both functional limitations (inability to perform physical tasks - Activity Limitation Domain score, range: 0-100) and disability (inability to perform major life tasks and social roles - Participation Restriction Domain score, range: 0-100). For both scales, higher values indicate better function (lower limitation or lower disability). Two domain scores are analyzed separately.

Recruitment status

COMPLETED

Study phase

Target enrollment

64 participants

Primary outcome timeframe

At baseline and week 8

Results posted on

2021-07-21

Participant Flow

Between August 2017 and February 2020, 64 patients were enrolled from the Beth Israel Deaconess Medical Center and the Brigham and Women's Hospital in Boston, MA.

10 participants were disenrolled due to medical complications (n=5), rehabilitation facility discharge (n=2), and unavailability of the research team for assessment (n=3).

Participant milestones

Participant milestones
Measure	Exercise & Cognitive Behavioral Int. A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins. Cognitive behavioral interventions: The following cognitive-behavioral strategies will be employed: 1) enhance positive beliefs about exercise through discussion of benefits of exercise; 2) discussion of barriers to exercise; 3) individualized goal setting and self-monitoring progress using exercise calendar; 4) develop a detailed exercise plan on how, what, when, and where to conduct exercise; 5) $10 rewards for exercising ≥30 mins per day for ≥5 of 7 days. The duration of this intervention is about 20 mins.	Exercise Alone A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program, without cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins.	Attention Control Education Program Participants will receive telephone-based education sessions from a study health professional. Attention control education program: A health care professional will call the participant weekly for a period of 8 weeks to teach general tips about exercise and diet (source: https://go4life.nia.nih.gov/). No recommendations for a specific exercise program will be made, except for walking 30 minutes daily or as tolerated. Each telephone session will cover 4 exercise tips and 4 healthy eating tips. The duration of the intervention is about 30 minutes.
Overall Study STARTED	18	17	19
Overall Study COMPLETED	16	13	16
Overall Study NOT COMPLETED	2	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Exercise & Cognitive Behavioral Int. A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins. Cognitive behavioral interventions: The following cognitive-behavioral strategies will be employed: 1) enhance positive beliefs about exercise through discussion of benefits of exercise; 2) discussion of barriers to exercise; 3) individualized goal setting and self-monitoring progress using exercise calendar; 4) develop a detailed exercise plan on how, what, when, and where to conduct exercise; 5) $10 rewards for exercising ≥30 mins per day for ≥5 of 7 days. The duration of this intervention is about 20 mins.	Exercise Alone A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program, without cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins.	Attention Control Education Program Participants will receive telephone-based education sessions from a study health professional. Attention control education program: A health care professional will call the participant weekly for a period of 8 weeks to teach general tips about exercise and diet (source: https://go4life.nia.nih.gov/). No recommendations for a specific exercise program will be made, except for walking 30 minutes daily or as tolerated. Each telephone session will cover 4 exercise tips and 4 healthy eating tips. The duration of the intervention is about 30 minutes.
Overall Study Lost to Follow-up	2	2	2
Overall Study Post-Randomization Exclusion	0	2	1

Baseline Characteristics

Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exercise & Cognitive Behavioral Int. n=18 Participants A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins. Cognitive behavioral interventions: The following cognitive-behavioral strategies will be employed: 1) enhance positive beliefs about exercise through discussion of benefits of exercise; 2) discussion of barriers to exercise; 3) individualized goal setting and self-monitoring progress using exercise calendar; 4) develop a detailed exercise plan on how, what, when, and where to conduct exercise; 5) $10 rewards for exercising ≥30 mins per day for ≥5 of 7 days. The duration of this intervention is about 20 mins.	Exercise Alone n=15 Participants A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program, without cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins.	Attention Control Education Program n=18 Participants Participants will receive telephone-based education sessions from a study health professional. Attention control education program: A health care professional will call the participant weekly for a period of 8 weeks to teach general tips about exercise and diet (source: https://go4life.nia.nih.gov/). No recommendations for a specific exercise program will be made, except for walking 30 minutes daily or as tolerated. Each telephone session will cover 4 exercise tips and 4 healthy eating tips. The duration of the intervention is about 30 minutes.	Total n=51 Participants Total of all reporting groups
Age, Continuous	85.1 years STANDARD_DEVIATION 9.1 • n=5 Participants	84.9 years STANDARD_DEVIATION 5.1 • n=7 Participants	82.8 years STANDARD_DEVIATION 8.0 • n=5 Participants	84.2 years STANDARD_DEVIATION 7.6 • n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	1 Participants n=7 Participants	9 Participants n=5 Participants	19 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	14 Participants n=7 Participants	9 Participants n=5 Participants	32 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	15 Participants n=7 Participants	17 Participants n=5 Participants	50 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	18 participants n=5 Participants	15 participants n=7 Participants	18 participants n=5 Participants	51 participants n=4 Participants
New York Heart Association Class 3-4	8 Participants n=5 Participants	9 Participants n=7 Participants	6 Participants n=5 Participants	23 Participants n=4 Participants
Aortic valve area	0.79 cm^2 STANDARD_DEVIATION 0.21 • n=5 Participants	0.80 cm^2 STANDARD_DEVIATION 0.22 • n=7 Participants	0.80 cm^2 STANDARD_DEVIATION 0.20 • n=5 Participants	0.80 cm^2 STANDARD_DEVIATION 0.20 • n=4 Participants
Left ventricular ejection fraction	60.6 % STANDARD_DEVIATION 9.4 • n=5 Participants	57.0 % STANDARD_DEVIATION 8.1 • n=7 Participants	56.1 % STANDARD_DEVIATION 15.6 • n=5 Participants	58.0 % STANDARD_DEVIATION 11.6 • n=4 Participants
Body mass index	27.5 kg/m2 STANDARD_DEVIATION 6.4 • n=5 Participants	27.9 kg/m2 STANDARD_DEVIATION 4.8 • n=7 Participants	30.6 kg/m2 STANDARD_DEVIATION 6.3 • n=5 Participants	28.7 kg/m2 STANDARD_DEVIATION 6.0 • n=4 Participants
At risk of malnutrition	8 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	18 Participants n=4 Participants
Mini-Mental State Examination score	25.8 units on a scale STANDARD_DEVIATION 3.0 • n=5 Participants	25.8 units on a scale STANDARD_DEVIATION 3.0 • n=7 Participants	25.4 units on a scale STANDARD_DEVIATION 4.0 • n=5 Participants	25.7 units on a scale STANDARD_DEVIATION 3.3 • n=4 Participants
Activities of daily living dependence	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Instrumental activities of daily living dependence	6 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	22 Participants n=4 Participants
Gait speed	0.73 meter/second STANDARD_DEVIATION 0.29 • n=5 Participants	0.65 meter/second STANDARD_DEVIATION 0.25 • n=7 Participants	0.58 meter/second STANDARD_DEVIATION 0.23 • n=5 Participants	0.65 meter/second STANDARD_DEVIATION 0.26 • n=4 Participants

PRIMARY outcome

Timeframe: At baseline and week 8

Population: The LLFDI Computer Adaptive Test software for Windows could not be run after the Windows operating system upgrade during our study period. LLFDI scores were available for 36 participants at baseline and 10 participants at 8 weeks. Therefore, we were unable to analyze the LLFDI score change. Instead, we measured a disability score (count of 22 daily activities and physical tasks that a person cannot perform without another person's help) post-hoc (see post-hoc outcome measure).

Outcome measures

Outcome measures
Measure	Exercise & Cognitive Behavioral Int. n=13 Participants A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins. Cognitive behavioral interventions: The following cognitive-behavioral strategies will be employed: 1) enhance positive beliefs about exercise through discussion of benefits of exercise; 2) discussion of barriers to exercise; 3) individualized goal setting and self-monitoring progress using exercise calendar; 4) develop a detailed exercise plan on how, what, when, and where to conduct exercise; 5) $10 rewards for exercising ≥30 mins per day for ≥5 of 7 days. The duration of this intervention is about 20 mins.	Exercise Alone n=12 Participants A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program, without cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins.	Attention Control Education Program n=11 Participants Participants will receive telephone-based education sessions from a study health professional. Attention control education program: A health care professional will call the participant weekly for a period of 8 weeks to teach general tips about exercise and diet (source: https://go4life.nia.nih.gov/). No recommendations for a specific exercise program will be made, except for walking 30 minutes daily or as tolerated. Each telephone session will cover 4 exercise tips and 4 healthy eating tips. The duration of the intervention is about 30 minutes.
Change in the Late-Life Function and Disability Instrument (LLFDI) Score Activity Limitation Domain - Baseline	53.2 units on a scale Standard Deviation 7.2	52.0 units on a scale Standard Deviation 8.6	52.9 units on a scale Standard Deviation 5.9
Change in the Late-Life Function and Disability Instrument (LLFDI) Score Activity Limitation Domain - Week 8	58.9 units on a scale Standard Deviation 9.5	43 units on a scale Standard Deviation 2.8	54.4 units on a scale Standard Deviation 6.4
Change in the Late-Life Function and Disability Instrument (LLFDI) Score Participation Restriction Domain - Baseline	48.7 units on a scale Standard Deviation 8.1	47.2 units on a scale Standard Deviation 8.6	47.3 units on a scale Standard Deviation 5.8
Change in the Late-Life Function and Disability Instrument (LLFDI) Score Participation Restriction Domain - Week 8	49.1 units on a scale Standard Deviation 12.0	35.3 units on a scale Standard Deviation 1.4	47.5 units on a scale Standard Deviation 13.7

SECONDARY outcome

Timeframe: At baseline and week 8

Population: Participants with available data were analyzed.

The summary score is calculated based on chair stands, walking speed, and standing balance (range: 0-12). Higher scores indicate better physical performance.

Outcome measures

Outcome measures
Measure	Exercise & Cognitive Behavioral Int. n=13 Participants A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins. Cognitive behavioral interventions: The following cognitive-behavioral strategies will be employed: 1) enhance positive beliefs about exercise through discussion of benefits of exercise; 2) discussion of barriers to exercise; 3) individualized goal setting and self-monitoring progress using exercise calendar; 4) develop a detailed exercise plan on how, what, when, and where to conduct exercise; 5) $10 rewards for exercising ≥30 mins per day for ≥5 of 7 days. The duration of this intervention is about 20 mins.	Exercise Alone n=10 Participants A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program, without cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins.	Attention Control Education Program n=11 Participants Participants will receive telephone-based education sessions from a study health professional. Attention control education program: A health care professional will call the participant weekly for a period of 8 weeks to teach general tips about exercise and diet (source: https://go4life.nia.nih.gov/). No recommendations for a specific exercise program will be made, except for walking 30 minutes daily or as tolerated. Each telephone session will cover 4 exercise tips and 4 healthy eating tips. The duration of the intervention is about 30 minutes.
Change in the Short Physical Performance Battery (SPPB) Summary Score Baseline	5.9 units on a scale Standard Error 0.7	4.5 units on a scale Standard Error 0.8	5.3 units on a scale Standard Error 0.7
Change in the Short Physical Performance Battery (SPPB) Summary Score Week 8	9.7 units on a scale Standard Error 0.8	9.3 units on a scale Standard Error 0.9	6.5 units on a scale Standard Error 0.8

SECONDARY outcome

Timeframe: At baseline and week 8

Population: Participants with available data were analyzed.

The 2-minute walk distance measures endurance. A longer distance indicates better endurance.

Outcome measures

Outcome measures
Measure	Exercise & Cognitive Behavioral Int. n=10 Participants A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins. Cognitive behavioral interventions: The following cognitive-behavioral strategies will be employed: 1) enhance positive beliefs about exercise through discussion of benefits of exercise; 2) discussion of barriers to exercise; 3) individualized goal setting and self-monitoring progress using exercise calendar; 4) develop a detailed exercise plan on how, what, when, and where to conduct exercise; 5) $10 rewards for exercising ≥30 mins per day for ≥5 of 7 days. The duration of this intervention is about 20 mins.	Exercise Alone n=7 Participants A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program, without cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins.	Attention Control Education Program n=7 Participants Participants will receive telephone-based education sessions from a study health professional. Attention control education program: A health care professional will call the participant weekly for a period of 8 weeks to teach general tips about exercise and diet (source: https://go4life.nia.nih.gov/). No recommendations for a specific exercise program will be made, except for walking 30 minutes daily or as tolerated. Each telephone session will cover 4 exercise tips and 4 healthy eating tips. The duration of the intervention is about 30 minutes.
Change in the 2-Minute Walk Distance (Feet) Baseline	313.9 feet Standard Error 27.2	279.0 feet Standard Error 31.1	244.6 feet Standard Error 32.8
Change in the 2-Minute Walk Distance (Feet) Week 8	333.0 feet Standard Error 25.4	357.4 feet Standard Error 29.5	282.8 feet Standard Error 29.4

SECONDARY outcome

Timeframe: At baseline and week 8

Population: Participants with available data were analyzed.

Dominant hand grip strength measures upper extremity strength.

Outcome measures

Outcome measures
Measure	Exercise & Cognitive Behavioral Int. n=12 Participants A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins. Cognitive behavioral interventions: The following cognitive-behavioral strategies will be employed: 1) enhance positive beliefs about exercise through discussion of benefits of exercise; 2) discussion of barriers to exercise; 3) individualized goal setting and self-monitoring progress using exercise calendar; 4) develop a detailed exercise plan on how, what, when, and where to conduct exercise; 5) $10 rewards for exercising ≥30 mins per day for ≥5 of 7 days. The duration of this intervention is about 20 mins.	Exercise Alone n=9 Participants A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program, without cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins.	Attention Control Education Program n=13 Participants Participants will receive telephone-based education sessions from a study health professional. Attention control education program: A health care professional will call the participant weekly for a period of 8 weeks to teach general tips about exercise and diet (source: https://go4life.nia.nih.gov/). No recommendations for a specific exercise program will be made, except for walking 30 minutes daily or as tolerated. Each telephone session will cover 4 exercise tips and 4 healthy eating tips. The duration of the intervention is about 30 minutes.
Change in Dominant Hand Grip Strength (kg) Baseline	21.8 kg Standard Error 2.9	23.7 kg Standard Error 3.4	19.5 kg Standard Error 2.8
Change in Dominant Hand Grip Strength (kg) Week 8	23.0 kg Standard Error 3.1	22.8 kg Standard Error 3.9	24.1 kg Standard Error 3.5

SECONDARY outcome

Timeframe: At week 8

Number of participants who experience any adverse events and serious adverse events

Outcome measures

Outcome measures
Measure	Exercise & Cognitive Behavioral Int. n=18 Participants A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins. Cognitive behavioral interventions: The following cognitive-behavioral strategies will be employed: 1) enhance positive beliefs about exercise through discussion of benefits of exercise; 2) discussion of barriers to exercise; 3) individualized goal setting and self-monitoring progress using exercise calendar; 4) develop a detailed exercise plan on how, what, when, and where to conduct exercise; 5) $10 rewards for exercising ≥30 mins per day for ≥5 of 7 days. The duration of this intervention is about 20 mins.	Exercise Alone n=15 Participants A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program, without cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins.	Attention Control Education Program n=18 Participants Participants will receive telephone-based education sessions from a study health professional. Attention control education program: A health care professional will call the participant weekly for a period of 8 weeks to teach general tips about exercise and diet (source: https://go4life.nia.nih.gov/). No recommendations for a specific exercise program will be made, except for walking 30 minutes daily or as tolerated. Each telephone session will cover 4 exercise tips and 4 healthy eating tips. The duration of the intervention is about 30 minutes.
Number of Participants Who Experienced Adverse Events Any adverse event	12 Participants	8 Participants	8 Participants
Number of Participants Who Experienced Adverse Events Any serious adverse event	1 Participants	2 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline and week 8

Population: Participants with available data were analyzed.

MMSE is an instrument that assesses general cognitive function (range: 0 to 30). Higher scores indicate better cognitive function.

Outcome measures

Outcome measures
Measure	Exercise & Cognitive Behavioral Int. n=17 Participants A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins. Cognitive behavioral interventions: The following cognitive-behavioral strategies will be employed: 1) enhance positive beliefs about exercise through discussion of benefits of exercise; 2) discussion of barriers to exercise; 3) individualized goal setting and self-monitoring progress using exercise calendar; 4) develop a detailed exercise plan on how, what, when, and where to conduct exercise; 5) $10 rewards for exercising ≥30 mins per day for ≥5 of 7 days. The duration of this intervention is about 20 mins.	Exercise Alone n=15 Participants A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program, without cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins.	Attention Control Education Program n=17 Participants Participants will receive telephone-based education sessions from a study health professional. Attention control education program: A health care professional will call the participant weekly for a period of 8 weeks to teach general tips about exercise and diet (source: https://go4life.nia.nih.gov/). No recommendations for a specific exercise program will be made, except for walking 30 minutes daily or as tolerated. Each telephone session will cover 4 exercise tips and 4 healthy eating tips. The duration of the intervention is about 30 minutes.
Change in Mini-Mental State Examination (MMSE) Score Baseline	25.8 units on a scale Standard Error 0.8	25.8 units on a scale Standard Error 0.8	25.4 units on a scale Standard Error 0.8
Change in Mini-Mental State Examination (MMSE) Score Week 8	26.7 units on a scale Standard Error 0.9	28.4 units on a scale Standard Error 1.1	27.7 units on a scale Standard Error 0.9

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline and week 8

Population: Participants with available data were analyzed.

NYHA assesses the extent of physical activity limitation due to heart failure. It ranges from 1 (ordinary physical activity does not cause symptoms) to 4 (symptoms occur at rest).

Outcome measures

Outcome measures
Measure	Exercise & Cognitive Behavioral Int. n=18 Participants A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins. Cognitive behavioral interventions: The following cognitive-behavioral strategies will be employed: 1) enhance positive beliefs about exercise through discussion of benefits of exercise; 2) discussion of barriers to exercise; 3) individualized goal setting and self-monitoring progress using exercise calendar; 4) develop a detailed exercise plan on how, what, when, and where to conduct exercise; 5) $10 rewards for exercising ≥30 mins per day for ≥5 of 7 days. The duration of this intervention is about 20 mins.	Exercise Alone n=15 Participants A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program, without cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins.	Attention Control Education Program n=18 Participants Participants will receive telephone-based education sessions from a study health professional. Attention control education program: A health care professional will call the participant weekly for a period of 8 weeks to teach general tips about exercise and diet (source: https://go4life.nia.nih.gov/). No recommendations for a specific exercise program will be made, except for walking 30 minutes daily or as tolerated. Each telephone session will cover 4 exercise tips and 4 healthy eating tips. The duration of the intervention is about 30 minutes.
Change in New York Heart Association (NYHA) Functional Class Baseline	2.4 units on a scale Standard Error 0.2	2.6 units on a scale Standard Error 0.2	2.2 units on a scale Standard Error 0.2
Change in New York Heart Association (NYHA) Functional Class Week 8	1.7 units on a scale Standard Error 0.2	1.8 units on a scale Standard Error 0.2	1.6 units on a scale Standard Error 0.2

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline and week 8

Population: Participants with available data were analyzed.

The SEE scale measures self-efficacy about exercise (range: 0-90). Higher values indicate higher self efficacy.

Outcome measures

Outcome measures
Measure	Exercise & Cognitive Behavioral Int. n=18 Participants A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins. Cognitive behavioral interventions: The following cognitive-behavioral strategies will be employed: 1) enhance positive beliefs about exercise through discussion of benefits of exercise; 2) discussion of barriers to exercise; 3) individualized goal setting and self-monitoring progress using exercise calendar; 4) develop a detailed exercise plan on how, what, when, and where to conduct exercise; 5) $10 rewards for exercising ≥30 mins per day for ≥5 of 7 days. The duration of this intervention is about 20 mins.	Exercise Alone n=15 Participants A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program, without cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins.	Attention Control Education Program n=18 Participants Participants will receive telephone-based education sessions from a study health professional. Attention control education program: A health care professional will call the participant weekly for a period of 8 weeks to teach general tips about exercise and diet (source: https://go4life.nia.nih.gov/). No recommendations for a specific exercise program will be made, except for walking 30 minutes daily or as tolerated. Each telephone session will cover 4 exercise tips and 4 healthy eating tips. The duration of the intervention is about 30 minutes.
Change in the Self-Efficacy Scale for Exercise (SEE) Baseline	50.5 units on a scale Standard Error 5.8	54.5 units on a scale Standard Error 6.2	53.6 units on a scale Standard Error 5.7
Change in the Self-Efficacy Scale for Exercise (SEE) Week 8	66.2 units on a scale Standard Error 6.9	59.6 units on a scale Standard Error 8.7	51.1 units on a scale Standard Error 6.8

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline and week 8

Population: Participants with available data were analyzed.

The OEE scale measures outcome expectation about exercise (range: 9-45). Higher scores indicate higher expectation.

Outcome measures

Outcome measures
Measure	Exercise & Cognitive Behavioral Int. n=18 Participants A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins. Cognitive behavioral interventions: The following cognitive-behavioral strategies will be employed: 1) enhance positive beliefs about exercise through discussion of benefits of exercise; 2) discussion of barriers to exercise; 3) individualized goal setting and self-monitoring progress using exercise calendar; 4) develop a detailed exercise plan on how, what, when, and where to conduct exercise; 5) $10 rewards for exercising ≥30 mins per day for ≥5 of 7 days. The duration of this intervention is about 20 mins.	Exercise Alone n=15 Participants A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program, without cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins.	Attention Control Education Program n=18 Participants Participants will receive telephone-based education sessions from a study health professional. Attention control education program: A health care professional will call the participant weekly for a period of 8 weeks to teach general tips about exercise and diet (source: https://go4life.nia.nih.gov/). No recommendations for a specific exercise program will be made, except for walking 30 minutes daily or as tolerated. Each telephone session will cover 4 exercise tips and 4 healthy eating tips. The duration of the intervention is about 30 minutes.
Change in the Outcome Expectation Scale for Exercise (OEE) Baseline	19.0 units on a scale Standard Error 1.3	19.2 units on a scale Standard Error 1.5	18.2 units on a scale Standard Error 1.4
Change in the Outcome Expectation Scale for Exercise (OEE) Week 8	16.8 units on a scale Standard Error 1.5	16.6 units on a scale Standard Error 1.9	15.7 units on a scale Standard Error 1.6

OTHER_PRE_SPECIFIED outcome

Timeframe: At week 8

The proportion of days with completed daily task during the entire study period will be measured.

Outcome measures

Outcome data not reported

POST_HOC outcome

Timeframe: At baseline and week 8

Population: Participants with available data were analyzed.

The disability score measures the count of 22 daily activities and physical tasks that a person cannot perform without another person's help. It ranges from 0 to 22. Higher values indicate severe disability. Its correlation with LLFDI was -0.76 against the Activity Limitation Domain score and -0.65 against the Participation Restriction Domain score.

Outcome measures

Outcome measures
Measure	Exercise & Cognitive Behavioral Int. n=18 Participants A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins. Cognitive behavioral interventions: The following cognitive-behavioral strategies will be employed: 1) enhance positive beliefs about exercise through discussion of benefits of exercise; 2) discussion of barriers to exercise; 3) individualized goal setting and self-monitoring progress using exercise calendar; 4) develop a detailed exercise plan on how, what, when, and where to conduct exercise; 5) $10 rewards for exercising ≥30 mins per day for ≥5 of 7 days. The duration of this intervention is about 20 mins.	Exercise Alone n=15 Participants A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program, without cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins.	Attention Control Education Program n=18 Participants Participants will receive telephone-based education sessions from a study health professional. Attention control education program: A health care professional will call the participant weekly for a period of 8 weeks to teach general tips about exercise and diet (source: https://go4life.nia.nih.gov/). No recommendations for a specific exercise program will be made, except for walking 30 minutes daily or as tolerated. Each telephone session will cover 4 exercise tips and 4 healthy eating tips. The duration of the intervention is about 30 minutes.
Disability Score Baseline	2.8 units on a scale Standard Error 0.4	3.1 units on a scale Standard Error 0.5	3.8 units on a scale Standard Error 0.5
Disability Score Week 8	2.1 units on a scale Standard Error 0.4	3.4 units on a scale Standard Error 0.5	4.5 units on a scale Standard Error 0.5

Adverse Events

Exercise & Cognitive Behavioral Int.

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Exercise Alone

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Attention Control Education Program

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Exercise & Cognitive Behavioral Int. n=18 participants at risk A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins. Cognitive behavioral interventions: The following cognitive-behavioral strategies will be employed: 1) enhance positive beliefs about exercise through discussion of benefits of exercise; 2) discussion of barriers to exercise; 3) individualized goal setting and self-monitoring progress using exercise calendar; 4) develop a detailed exercise plan on how, what, when, and where to conduct exercise; 5) $10 rewards for exercising ≥30 mins per day for ≥5 of 7 days. The duration of this intervention is about 20 mins.	Exercise Alone n=15 participants at risk A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program, without cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins.	Attention Control Education Program n=18 participants at risk Participants will receive telephone-based education sessions from a study health professional. Attention control education program: A health care professional will call the participant weekly for a period of 8 weeks to teach general tips about exercise and diet (source: https://go4life.nia.nih.gov/). No recommendations for a specific exercise program will be made, except for walking 30 minutes daily or as tolerated. Each telephone session will cover 4 exercise tips and 4 healthy eating tips. The duration of the intervention is about 30 minutes.
Cardiac disorders Chest pain	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.	6.7% 1/15 • Number of events 1 • Adverse events were collected during the 8-week intervention period.	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.
Gastrointestinal disorders Diarrhea	5.6% 1/18 • Number of events 1 • Adverse events were collected during the 8-week intervention period.	0.00% 0/15 • Adverse events were collected during the 8-week intervention period.	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.
Nervous system disorders Dizziness	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.	6.7% 1/15 • Number of events 1 • Adverse events were collected during the 8-week intervention period.	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.
Psychiatric disorders Hallucination	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.	6.7% 1/15 • Number of events 1 • Adverse events were collected during the 8-week intervention period.	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.
Cardiac disorders Heart failure	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.	0.00% 0/15 • Adverse events were collected during the 8-week intervention period.	5.6% 1/18 • Number of events 1 • Adverse events were collected during the 8-week intervention period.
Blood and lymphatic system disorders Epistaxis	5.6% 1/18 • Number of events 1 • Adverse events were collected during the 8-week intervention period.	0.00% 0/15 • Adverse events were collected during the 8-week intervention period.	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.
Nervous system disorders Seizure	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.	0.00% 0/15 • Adverse events were collected during the 8-week intervention period.	5.6% 1/18 • Number of events 1 • Adverse events were collected during the 8-week intervention period.

Other adverse events

Additional Information

Dr. Dae Hyun Kim, Associate Scientist

Hebrew SeniorLife Marcus Institute for Aging Research

Phone: 617-632-5362

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Exercise & Cognitive Behavioral Int. n=18 participants at risk A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins. Cognitive behavioral interventions: The following cognitive-behavioral strategies will be employed: 1) enhance positive beliefs about exercise through discussion of benefits of exercise; 2) discussion of barriers to exercise; 3) individualized goal setting and self-monitoring progress using exercise calendar; 4) develop a detailed exercise plan on how, what, when, and where to conduct exercise; 5) $10 rewards for exercising ≥30 mins per day for ≥5 of 7 days. The duration of this intervention is about 20 mins.	Exercise Alone n=15 participants at risk A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program, without cognitive behavioral interventions. Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins.	Attention Control Education Program n=18 participants at risk Participants will receive telephone-based education sessions from a study health professional. Attention control education program: A health care professional will call the participant weekly for a period of 8 weeks to teach general tips about exercise and diet (source: https://go4life.nia.nih.gov/). No recommendations for a specific exercise program will be made, except for walking 30 minutes daily or as tolerated. Each telephone session will cover 4 exercise tips and 4 healthy eating tips. The duration of the intervention is about 30 minutes.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	27.8% 5/18 • Number of events 6 • Adverse events were collected during the 8-week intervention period.	20.0% 3/15 • Number of events 3 • Adverse events were collected during the 8-week intervention period.	16.7% 3/18 • Number of events 4 • Adverse events were collected during the 8-week intervention period.
Cardiac disorders Chest pain	16.7% 3/18 • Number of events 3 • Adverse events were collected during the 8-week intervention period.	6.7% 1/15 • Number of events 1 • Adverse events were collected during the 8-week intervention period.	11.1% 2/18 • Number of events 3 • Adverse events were collected during the 8-week intervention period.
General disorders Fatigue	16.7% 3/18 • Number of events 3 • Adverse events were collected during the 8-week intervention period.	6.7% 1/15 • Number of events 1 • Adverse events were collected during the 8-week intervention period.	11.1% 2/18 • Number of events 2 • Adverse events were collected during the 8-week intervention period.
Nervous system disorders Dizziness	11.1% 2/18 • Number of events 2 • Adverse events were collected during the 8-week intervention period.	13.3% 2/15 • Number of events 2 • Adverse events were collected during the 8-week intervention period.	5.6% 1/18 • Number of events 1 • Adverse events were collected during the 8-week intervention period.
Injury, poisoning and procedural complications Fall	5.6% 1/18 • Number of events 1 • Adverse events were collected during the 8-week intervention period.	6.7% 1/15 • Number of events 1 • Adverse events were collected during the 8-week intervention period.	5.6% 1/18 • Number of events 1 • Adverse events were collected during the 8-week intervention period.
Investigations Abnormal blood test	5.6% 1/18 • Number of events 1 • Adverse events were collected during the 8-week intervention period.	0.00% 0/15 • Adverse events were collected during the 8-week intervention period.	5.6% 1/18 • Number of events 1 • Adverse events were collected during the 8-week intervention period.
Cardiac disorders Elevated blood pressure	5.6% 1/18 • Number of events 1 • Adverse events were collected during the 8-week intervention period.	6.7% 1/15 • Number of events 1 • Adverse events were collected during the 8-week intervention period.	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.
Cardiac disorders Leg swelling	5.6% 1/18 • Number of events 1 • Adverse events were collected during the 8-week intervention period.	6.7% 1/15 • Number of events 1 • Adverse events were collected during the 8-week intervention period.	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.
Gastrointestinal disorders Abdominal pain	5.6% 1/18 • Number of events 1 • Adverse events were collected during the 8-week intervention period.	0.00% 0/15 • Adverse events were collected during the 8-week intervention period.	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.
Cardiac disorders Angina	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.	6.7% 1/15 • Number of events 1 • Adverse events were collected during the 8-week intervention period.	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.
Cardiac disorders Arrhythmia	5.6% 1/18 • Number of events 1 • Adverse events were collected during the 8-week intervention period.	0.00% 0/15 • Adverse events were collected during the 8-week intervention period.	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.
General disorders Cold intolerance	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.	0.00% 0/15 • Adverse events were collected during the 8-week intervention period.	5.6% 1/18 • Number of events 1 • Adverse events were collected during the 8-week intervention period.
Nervous system disorders Confusion	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.	0.00% 0/15 • Adverse events were collected during the 8-week intervention period.	5.6% 1/18 • Number of events 1 • Adverse events were collected during the 8-week intervention period.
Metabolism and nutrition disorders Dehydration	5.6% 1/18 • Number of events 1 • Adverse events were collected during the 8-week intervention period.	0.00% 0/15 • Adverse events were collected during the 8-week intervention period.	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.
Gastrointestinal disorders Diarrhea	5.6% 1/18 • Number of events 1 • Adverse events were collected during the 8-week intervention period.	0.00% 0/15 • Adverse events were collected during the 8-week intervention period.	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.
Nervous system disorders Dyskinesia	5.6% 1/18 • Number of events 1 • Adverse events were collected during the 8-week intervention period.	0.00% 0/15 • Adverse events were collected during the 8-week intervention period.	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.
Respiratory, thoracic and mediastinal disorders Dyspnea at rest	5.6% 1/18 • Number of events 1 • Adverse events were collected during the 8-week intervention period.	0.00% 0/15 • Adverse events were collected during the 8-week intervention period.	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.
Respiratory, thoracic and mediastinal disorders Dyspnea on exertion	5.6% 1/18 • Number of events 1 • Adverse events were collected during the 8-week intervention period.	0.00% 0/15 • Adverse events were collected during the 8-week intervention period.	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.
Psychiatric disorders Hallucination	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.	6.7% 1/15 • Number of events 1 • Adverse events were collected during the 8-week intervention period.	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.
Nervous system disorders Headache	5.6% 1/18 • Number of events 1 • Adverse events were collected during the 8-week intervention period.	0.00% 0/15 • Adverse events were collected during the 8-week intervention period.	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.
Cardiac disorders Heart failure	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.	0.00% 0/15 • Adverse events were collected during the 8-week intervention period.	5.6% 1/18 • Number of events 1 • Adverse events were collected during the 8-week intervention period.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.	0.00% 0/15 • Adverse events were collected during the 8-week intervention period.	5.6% 1/18 • Number of events 1 • Adverse events were collected during the 8-week intervention period.
Gastrointestinal disorders Nausea	5.6% 1/18 • Number of events 1 • Adverse events were collected during the 8-week intervention period.	0.00% 0/15 • Adverse events were collected during the 8-week intervention period.	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.
Blood and lymphatic system disorders Epistaxis	5.6% 1/18 • Number of events 1 • Adverse events were collected during the 8-week intervention period.	0.00% 0/15 • Adverse events were collected during the 8-week intervention period.	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.
Cardiac disorders Palpitation	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.	6.7% 1/15 • Number of events 1 • Adverse events were collected during the 8-week intervention period.	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.
Nervous system disorders Seizure	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.	0.00% 0/15 • Adverse events were collected during the 8-week intervention period.	5.6% 1/18 • Number of events 1 • Adverse events were collected during the 8-week intervention period.
Infections and infestations Urinary tract infection	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.	0.00% 0/15 • Adverse events were collected during the 8-week intervention period.	5.6% 1/18 • Number of events 1 • Adverse events were collected during the 8-week intervention period.
Cardiac disorders Myocardial infarction	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.	0.00% 0/15 • Adverse events were collected during the 8-week intervention period.	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.
Nervous system disorders Stroke	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.	0.00% 0/15 • Adverse events were collected during the 8-week intervention period.	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.
Nervous system disorders Syncope	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.	0.00% 0/15 • Adverse events were collected during the 8-week intervention period.	0.00% 0/18 • Adverse events were collected during the 8-week intervention period.