Trial Outcomes & Findings for Home-based Exercise Intervention for Patients With Metastatic Prostate Cancer (NCT NCT03672396)

NCT ID: NCT03672396

Last Updated: 2021-04-20

Results Overview

To estimate the feasibility of a 12 week, home-based exercise intervention in metastatic castrate resistant prostate cancer (mCPRC) patients undergoing androgen deprivation therapy by reporting the percentage of patients who complete the pre/post testing following the intervention. This was calculated as the number of subjects who completed the trial compared to the total number who completed baseline testing.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: 12 weeks after baseline testing
• Results posted on: 2021-04-20

Participant Flow

Subjects were recruited from 4/16/2017 through 12/5/2019 from referrals from medical oncologists from three institutions.

62 subjects were referred to the study. Of this, 40 did not participate or qualify for the study. 22 subjects were consented and 16 completed all aspects of the trial.

Participant milestones

Measure	Home-based Exercise The sole intervention group will complete a combination of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. Home-based exercise: The intervention consists of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.
Overall Study STARTED	22
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Home-based Exercise The sole intervention group will complete a combination of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. Home-based exercise: The intervention consists of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.
Overall Study Withdrawal by Subject	4
Overall Study Physician Decision	1
Overall Study Adverse Event	1

Baseline Characteristics

Home-based Exercise Intervention for Patients With Metastatic Prostate Cancer

Baseline characteristics by cohort

Measure	Home-based Exercise n=16 Participants The sole intervention group will complete a combination of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. Home-based exercise: The intervention consists of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.
Age, Continuous	72 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants
Height	172.4 cm STANDARD_DEVIATION 4.6 • n=5 Participants
Mass	86.2 kg STANDARD_DEVIATION 19.6 • n=5 Participants
Body Mass Index	28.90 kg/m^2 STANDARD_DEVIATION 6.00 • n=5 Participants
Duration of Androgen Deprivation Therapy (ADT)	1132 days STANDARD_DEVIATION 1369 • n=5 Participants
Previous Prostatectomy	7 Participants n=5 Participants
Previous Radiotherapy	11 Participants n=5 Participants
Previous Chemotherapy	5 Participants n=5 Participants
Time since Chemotherapy	13 months STANDARD_DEVIATION 5 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks after baseline testing

Population: All participants in the trial.

To estimate the feasibility of a 12 week, home-based exercise intervention in metastatic castrate resistant prostate cancer (mCPRC) patients undergoing androgen deprivation therapy by reporting the percentage of patients who complete the pre/post testing following the intervention.

This was calculated as the number of subjects who completed the trial compared to the total number who completed baseline testing.

Outcome measures

Measure

Home-based Exercise n=22 Participants The sole intervention group will complete a combination of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. Home-based exercise: The intervention consists of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.

Percentage of Patients Who Complete the Pre/Post Exercise Intervention Testing.

16 Participants

SECONDARY outcome

Timeframe: 12 weeks after baseline testing

Population: This analysis was restricted to subjects who completed the intervention and returned their training logs.

To report the level of adherence to the exercise intervention in patients completing pre/post testing. Successful adherence to the program is completion of 75% of all prescribed exercise and will be assessed using wearable technology to track walking and exercise logs to track resistance training adherence.

Adherence was determined as the number of exercise sessions attempted/completed over the total number of session prescribed.

Outcome measures

Measure	Home-based Exercise n=14 Participants The sole intervention group will complete a combination of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. Home-based exercise: The intervention consists of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.
Adherence to the Intervention Overall	80.1 percentage of total sessions prescribed
Adherence to the Intervention Walking	65.5 percentage of total sessions prescribed
Adherence to the Intervention Resistance Training	72.8 percentage of total sessions prescribed

SECONDARY outcome

Timeframe: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial.

The time to complete (in sec) the 6m rapid walk test will be performed.

Outcome measures

Measure	Home-based Exercise n=16 Participants The sole intervention group will complete a combination of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. Home-based exercise: The intervention consists of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.
Physical Function: 6m Walk Post Intervention	4.5 seconds Standard Deviation 1.5
Physical Function: 6m Walk Baseline	4.4 seconds Standard Deviation 1.5

SECONDARY outcome

Timeframe: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial.

The time to complete (in sec) the 2.44m (8 ft) timed up and go test will be performed as an indicator of agility, balance, and physical function. A lower total time is indicative of greater performance.

Outcome measures

Measure	Home-based Exercise n=16 Participants The sole intervention group will complete a combination of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. Home-based exercise: The intervention consists of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.
Physical Function: Timed Up and Go Baseline	10.4 seconds Standard Deviation 9.1
Physical Function: Timed Up and Go Post Intervention	10.8 seconds Standard Deviation 11.0

SECONDARY outcome

Timeframe: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial.

The time to climb a flight of stairs (in sec) will be performed as an indicator of functional strength, muscle power, and balance. A lower total time (and higher calculated power output) is indicative of greater performance.

Outcome measures

Measure	Home-based Exercise n=16 Participants The sole intervention group will complete a combination of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. Home-based exercise: The intervention consists of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.
Physical Function: Stair Climb Baseline	6.4 seconds Standard Deviation 2.8
Physical Function: Stair Climb Post Intervention	6.2 seconds Standard Deviation 3.2

SECONDARY outcome

Timeframe: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial.

The time to walk 400m (in sec) will be performed as an indicator of walking endurance and gait speed will be determined. A lower total time and higher gait speed indicates greater cardiorespiratory capacity and will be correlated with cardiopulmonary function scores (outcome 14).

Outcome measures

Measure	Home-based Exercise n=15 Participants The sole intervention group will complete a combination of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. Home-based exercise: The intervention consists of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.
Physical Function: 400m Walk Baseline	329.8 seconds Standard Deviation 97.8
Physical Function: 400m Walk Post Intervention	313.5 seconds Standard Deviation 87.3

SECONDARY outcome

Timeframe: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial and returned the questionnaires.

Fatigue will be measure using the Functional Assessment of Chronic Illness Therapy Fatigue, a 1 page form that uses a rating scale that goes from 0 to 52. It assesses the patient's fatigue levels in the last 7 days. It also measures how usual activities, performing work, walking, relationship, and enjoyment of life are affected by fatigue. A higher score indicates higher quality of life (and lower fatigue).

Outcome measures

Measure	Home-based Exercise n=9 Participants The sole intervention group will complete a combination of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. Home-based exercise: The intervention consists of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.
Patient Reported Outcomes: Fatigue Post Intervention	40 score on a scale Standard Deviation 11
Patient Reported Outcomes: Fatigue Baseline	39 score on a scale Standard Deviation 10

SECONDARY outcome

Timeframe: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial and returned the questionnaires.

Quality of life will be measured using the Functional Assessment of Cancer Therapy-Prostate (FACT-P). The FACT-P is composed of both multi-item scales and single-item measures. These include physical, social, emotional, and functional well-being, along with an assessment of prostate-specific health status. five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All of the individual questions are scored from 0-4 with total scores ranging between 0 and 156 where a higher number represents higher QoL.

Outcome measures

Measure	Home-based Exercise n=9 Participants The sole intervention group will complete a combination of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. Home-based exercise: The intervention consists of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.
Patient Reported Outcomes: Quality of Life Baseline	119 score on a scale Standard Deviation 20
Patient Reported Outcomes: Quality of Life Post Intervention	119 score on a scale Standard Deviation 16

SECONDARY outcome

Timeframe: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial and returned the questionnaires.

Depression will be measured using the Hospital Anxiety and Depression Scale, a concise, self-administered 1 page form that categorizes anxiety and depression. The total score goes from 0-21, and scores are categorized from minimal to severe depression/anxiety. Higher total scores indicate greater levels of depression.

Outcome measures

Measure	Home-based Exercise n=9 Participants The sole intervention group will complete a combination of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. Home-based exercise: The intervention consists of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.
Patient Reported Outcomes: Depression Baseline	3 score on a scale Standard Deviation 2
Patient Reported Outcomes: Depression Post Intervention	3 score on a scale Standard Deviation 3

SECONDARY outcome

Timeframe: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial and returned the questionnaires.

Depression will be measured using the Hospital Anxiety and Depression Scale, a concise, self-administered 1 page form that categorizes anxiety and depression. The total score goes from 0-21, and scores are categorized from minimal to severe depression/anxiety. Higher total scores indicate greater levels of depression.

Outcome measures

Measure	Home-based Exercise n=9 Participants The sole intervention group will complete a combination of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. Home-based exercise: The intervention consists of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.
Patient Reported Outcomes: Anxiety Baseline	4 score on a scale Standard Deviation 3
Patient Reported Outcomes: Anxiety Post Intervention	3 score on a scale Standard Deviation 2

SECONDARY outcome

Timeframe: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial and were tested at the University of North Carolina (UNC) site only. Equipment to perform this analysis at the Wake Forest site was not available.

Muscle size will be analyzed using ultrasound of the vastus lateralis of the dominant leg. All assessments will be completed before and after the intervention to determine the muscle size. Higher muscle mass and quality are associated with greater muscle strength, physical function, QoL, and mortality.

Outcome measures

Measure	Home-based Exercise n=13 Participants The sole intervention group will complete a combination of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. Home-based exercise: The intervention consists of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.
Muscle Size (Cross-sectional Area) Baseline	8.3 cm^2 Standard Deviation 2.9
Muscle Size (Cross-sectional Area) Post Intervention	10.2 cm^2 Standard Deviation 4.0

SECONDARY outcome

Timeframe: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial and were tested at the UNC site.

Muscle architecture will be analyzed using ultrasound of the vastus lateralis of the dominant leg. All assessments will be completed before and after the intervention to determine the muscle quality. Higher muscle mass and quality are associated with greater muscle strength, physical function, QoL, and mortality. Muscle quality is reported in arbitrary units, where a lower value indicates a higher/better muscle quality.

Outcome measures

Measure	Home-based Exercise n=13 Participants The sole intervention group will complete a combination of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. Home-based exercise: The intervention consists of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.
Muscle Quality Baseline	110.2 unitless Standard Deviation 22
Muscle Quality Post Intervention	114.3 unitless Standard Deviation 16.6

SECONDARY outcome

Timeframe: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial and were tested at the UNC site.

Upper and lower body muscle strength will be assessed using the chest and leg presses. Maximal strength is defined as the highest load (kilograms) that the participant can successfully lift one time. Greater maximal strength is associated with greater physical function and QoL.

Outcome measures

Measure	Home-based Exercise n=14 Participants The sole intervention group will complete a combination of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. Home-based exercise: The intervention consists of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.
Chest Press Maximal Strength Baseline	62.4 kg Standard Deviation 21.4
Chest Press Maximal Strength Post Intervention	62.0 kg Standard Deviation 13.3

SECONDARY outcome

Timeframe: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial and were tested at the UNC site.

Upper and lower body muscle endurance will be assessed using the chest and leg presses. Muscle endurance is the total number of repetitions completed using 70% of maximal load determined during muscle strength testing (outcome 12). Greater muscle endurance are associated with greater physical function and QoL.

Outcome measures

Measure	Home-based Exercise n=14 Participants The sole intervention group will complete a combination of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. Home-based exercise: The intervention consists of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.
Chest Press Muscle Endurance Baseline	14.1 number of repetitions completed Standard Deviation 5
Chest Press Muscle Endurance Post Intervention	15.4 number of repetitions completed Standard Deviation 6.8

SECONDARY outcome

Timeframe: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial and were tested at the UNC site.

Upper and lower body muscle strength will be assessed using the chest and leg presses. Maximal strength is defined as the highest load (kilograms) that the participant can successfully lift one time. Greater maximal strength is associated with greater physical function and QoL.

Outcome measures

Measure	Home-based Exercise n=14 Participants The sole intervention group will complete a combination of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. Home-based exercise: The intervention consists of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.
Leg Press Maximal Strength Baseline	142.1 kg Standard Deviation 49.1
Leg Press Maximal Strength Post Intervention	141.5 kg Standard Deviation 52.0

SECONDARY outcome

Timeframe: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial and were tested at the UNC site.

Upper and lower body muscle endurance will be assessed using the chest and leg presses. Muscle endurance is the total number of repetitions completed using 70% of maximal load determined during muscle strength testing (outcome 12). Greater muscle endurance are associated with greater physical function and QoL.

Outcome measures

Measure	Home-based Exercise n=12 Participants The sole intervention group will complete a combination of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. Home-based exercise: The intervention consists of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.
Leg Press Muscle Endurance Baseline	11.8 number of repetitions completed Standard Deviation 6.7
Leg Press Muscle Endurance Post Intervention	14.1 number of repetitions completed Standard Deviation 6.4

SECONDARY outcome

Timeframe: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial.

To report changes in cardiopulmonary function following the intervention. Cardiopulmonary function (VO2 peak) will be assessed using a graded exercise test on a treadmill. Patients will begin the test walking slowly on the treadmill and every two minutes, the grade and speed of the treadmill will be increased in a progressive manner until fatigue occurs. Respiratory gases will be collected throughout the test and analyzed using a metabolic cart to determine oxygen utilization and carbon dioxide production. The maximal oxygen uptake that is recorded will be used as a marker of aerobic fitness.

Outcome measures

Measure	Home-based Exercise n=15 Participants The sole intervention group will complete a combination of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. Home-based exercise: The intervention consists of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.
Cardiopulmonary Function Baseline	19.3 mL/kg/min Standard Deviation 4.0
Cardiopulmonary Function Post Intervention	20.1 mL/kg/min Standard Deviation 5.6

SECONDARY outcome

Timeframe: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial and the body composition scans.

To report changes in total lean mass following the intervention. Total body lean mass will be measured using dual-energy x-ray absorptiometry (DXA) before and after the intervention.

Outcome measures

Measure	Home-based Exercise n=15 Participants The sole intervention group will complete a combination of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. Home-based exercise: The intervention consists of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.
Lean Mass Baseline	54.5 kg Standard Deviation 8.6
Lean Mass Post Intervention	51.4 kg Standard Deviation 16

SECONDARY outcome

Timeframe: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial and completed the body composition scans.

To report changes in total fat mass following the intervention. Total fat mass will be measured using dual-energy x-ray absorptiometry (DXA) before and after the intervention.

Outcome measures

Measure	Home-based Exercise n=15 Participants The sole intervention group will complete a combination of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. Home-based exercise: The intervention consists of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.
Fat Mass Post Intervention	28.4 kg Standard Deviation 15.2
Fat Mass Baseline	30 kg Standard Deviation 12.9

SECONDARY outcome

Timeframe: 12 weeks after baseline testing

Population: Data from pre vs. post intervention were analyzed using a paired t-test only in subjects who completed all aspects of the trial and the body composition scans.

To report changes in relative fat mass following the intervention. Total body percent fat (percentage of fat mass relative to total mass) will be measured using dual-energy x-ray absorptiometry (DXA) before and after the intervention.

Outcome measures

Measure	Home-based Exercise n=15 Participants The sole intervention group will complete a combination of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. Home-based exercise: The intervention consists of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.
Percent Body Fat Baseline	34.0 percentage of total body mass Standard Deviation 6.1
Percent Body Fat Post Intervention	34.3 percentage of total body mass Standard Deviation 6.6

Adverse Events

Home-based Exercise

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

Home-based Exercise n=22 participants at risk The sole intervention group will complete a combination of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. Home-based exercise: The intervention consists of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.

Musculoskeletal and connective tissue disorders calcium pyrophosphate deposition disease

4.5% 1/22 • Number of events 1 • 12 weeks

Additional Information

Erik Hanson, PhD

University of North Carolina at Chapel Hill

Phone: 19199620816

Email: edhanson@email.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place