Trial Outcomes & Findings for Measuring the Implementation of the LiFE Program in Primary Care for Older Adults Aged 75 Years or Older (NCT NCT02266225)

NCT ID: NCT02266225

Last Updated: 2019-08-26

Results Overview

Feasibility of recruitment is defined as the number of participants recruited (feasibility) over six months.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 48 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2019-08-26

Participant Flow

Participant milestones

Measure	Lifestyle-integrated Functional Exercise Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session
Overall Study STARTED	48
Overall Study Enrolled in Intervention	44
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Measure	Lifestyle-integrated Functional Exercise Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session
Overall Study Lost to Follow-up	2
Overall Study Death	1
Overall Study Withdrawal by Subject	13

Baseline Characteristics

Measuring the Implementation of the LiFE Program in Primary Care for Older Adults Aged 75 Years or Older

Baseline characteristics by cohort

Measure	Lifestyle-integrated Functional Exercise n=47 Participants Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session. Lifestyle-integrated Functional Exercise: Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	47 Participants n=5 Participants
Age, Continuous	80.6 years STANDARD_DEVIATION 5.1 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment Canada	47 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Feasibility of recruitment is defined as the number of participants recruited (feasibility) over six months.

Outcome measures

Measure	Lifestyle-integrated Functional Exercise n=48 Participants Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session
Feasibility of Recruitment	48 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Participants in the intervention

Retention is defined as the number of participants retained at Study Visit #1 (6-month follow-up).

Outcome measures

Measure	Lifestyle-integrated Functional Exercise n=48 Participants Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session
Retention	32 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Participants that enrolled in the intervention only

Adherence is defined as the number of days each week that the participant completes/integrates strength and balance activities into daily tasks. Adherence will be 100% if participants complete the balance and strength activities at least 3 days per week.

Outcome measures

Measure	Lifestyle-integrated Functional Exercise n=44 Participants Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session
Adherence (Including Withdrawals) Weeks 1-8	27 Participants
Adherence (Including Withdrawals) Weeks 9-16	25 Participants
Adherence (Including Withdrawals) Weeks 17-24	22 Participants

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: 21 participants completed accelerometer data collection at baseline and follow-up

• Participants will wear a physical activity monitor (Actigraph accelerometer) for seven days following Study Visit #1 (baseline) and Study Visit #2 (6 month follow-up) to determine the number of minutes spent sedentary and in light, moderate, and moderate-to-vigorous physical activity.
• Participants will complete the IPAQ at Study Visit #1 (baseline) and Study Visit #2 (6 month follow-up) to evaluate changes in self-reported time spent performing physical activity.

Outcome measures

Measure	Lifestyle-integrated Functional Exercise n=32 Participants Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session
Change in Physical Activity- Moderate-to-vigorous Physical Activity (MVPA) (Minutes/Week) Accelerometer - MVPA - Baseline	58.6 minutes/week Standard Deviation 111.1
Change in Physical Activity- Moderate-to-vigorous Physical Activity (MVPA) (Minutes/Week) Accelerometer - MVPA - 6 months	52.5 minutes/week Standard Deviation 96.8
Change in Physical Activity- Moderate-to-vigorous Physical Activity (MVPA) (Minutes/Week) IPAQ - MVPA - Baseline	41.2 minutes/week Standard Deviation 80.6
Change in Physical Activity- Moderate-to-vigorous Physical Activity (MVPA) (Minutes/Week) IPAQ - MVPA - 6 months	60.6 minutes/week Standard Deviation 125.1

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: Note: 5 participants partially completed follow-up data collection (we administered questionnaire data over the phone because certain participants were unwilling to come to our centre for data collection) and therefore, SPPB data collection at baseline and 6-month follow-up was reported in 27 participants.

The SPPB consists of balance tests (side-by-side, semi-tandem, and tandem standing), gait speed during 4-meter walk test, and the average time taken to rise from a chair with arms folded across chest and sit back down (Five-Times-Sit-to-Stand test), sub-scores of which are added to determine a composite score (0-12), with higher scores indicative of better performance. Participants will complete physical performance tests as a measure of balance, mobility, and leg strength at Study Visits 1 (Baseline) and 2 (at 6 months).

Outcome measures

Measure	Lifestyle-integrated Functional Exercise n=27 Participants Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session
Change in Physical Performance- Scores on the Short Physical Performance Battery (SPPB) Baseline	9.78 score on a scale Standard Deviation 1.97
Change in Physical Performance- Scores on the Short Physical Performance Battery (SPPB) 6 months	9.63 score on a scale Standard Deviation 2.26

SECONDARY outcome

Timeframe: Baseline, 6 months

Health-related quality of life will be assessed using the EQ5D health questionnaire at Study Visits 1 (Baseline) and 2 (at 6 months) to determine scores for all five dimensions (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and the visual analogue scale (VAS). EQ5D VAS scores range 0-100, with higher scores indicating better overall health.

Outcome measures

Measure	Lifestyle-integrated Functional Exercise n=32 Participants Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session
Change in Quality of Life- EQ5D Dimensions and VAS Score 6 months	76.17 units on a scale Standard Deviation 14.44
Change in Quality of Life- EQ5D Dimensions and VAS Score Baseline	70.84 units on a scale Standard Deviation 14.15

SECONDARY outcome

Timeframe: 6 months

Population: Note: 1 participant did not agree to data collection for secondary outcomes

Number of falls will be recorded daily on the postage-paid monthly diaries throughout the entire study (along with exercise information). A fall will be defined as an "a slip or a trip where the participant loses their balance and part or all of their body lands on the ground, floor or lower level".

Outcome measures

Measure	Lifestyle-integrated Functional Exercise n=47 Participants Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session
Number of Falls	19 falls

SECONDARY outcome

Timeframe: 6 months

Population: Note: 1 participant did not agree to data collection for secondary outcomes

Number of participants with falls will be recorded daily on the postage-paid monthly diaries throughout the entire study (along with exercise information). A fall will be defined as an "a slip or a trip where the participant loses their balance and part or all of their body lands on the ground, floor or lower level".

Outcome measures

Measure	Lifestyle-integrated Functional Exercise n=47 Participants Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session
Number of Participants With Falls	10 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Note: 1 participant did not agree to data collection for secondary outcomes

Number of participants with multiple falls will be recorded daily on the postage-paid monthly diaries throughout the entire study (along with exercise information). A fall will be defined as an "a slip or a trip where the participant loses their balance and part or all of their body lands on the ground, floor or lower level".

Outcome measures

Measure	Lifestyle-integrated Functional Exercise n=47 Participants Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session
Number of Participants With Multiple Falls	3 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Note: 1 participant did not agree to data collection for secondary outcomes

Participants will be instructed by the research coordinator and physiotherapist to report adverse events or injuries (serious or otherwise) to the research coordinator. Participants will be asked about illnesses or injuries at exercise sessions, follow-up phone calls, and Study Visit #2 (6 month follow-up). Intervention side effects (e.g., falls, fractures) and three types of adverse events will represent secondary outcomes (serious adverse events, adverse events possibly linked to the intervention, and adverse events that lead to study withdrawal or cessation of intervention).

Outcome measures

Measure	Lifestyle-integrated Functional Exercise n=47 Participants Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session
Number of Participants With Adverse Events or Injuries (Serious or Otherwise) Serious adverse events	5 Participants
Number of Participants With Adverse Events or Injuries (Serious or Otherwise) Non-serious adverse events	14 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Note: 1 participant did not agree to data collection for secondary outcomes.

Fidelity evaluation of video-taped exercise sessions for first and last cohorts in the intervention (all sessions for first and last 4-5 individuals forming a group) will be conducted. A rating of physiotherapist compliance and participant uptake and descriptive feedback will be obtained. Fidelity rating forms (designed in-house by the study team) were filled out for the individual session (e.g., purpose and aims of LiFE program explained) and group sessions (e.g., PT demonstrated the activity to the group and identified situations to embed the activity). Each program criterion was scored out of 2 (0 = not done at all, 1 = done but could be better, 2 = done well) for 34 criteria for the individual session and for 17 criteria for the group sessions with any disagreement resolved via third-party.

Outcome measures

Measure	Lifestyle-integrated Functional Exercise n=47 Participants Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session
Average Scores on Fidelity Rating Form - Individual and Group Sessions Individual session	1.8 score on a scale Standard Deviation 0.4
Average Scores on Fidelity Rating Form - Individual and Group Sessions Group session	1.9 score on a scale Standard Deviation 0.2

SECONDARY outcome

Timeframe: 6 months

Population: Note: 1 participant did not agree to data collection for secondary outcomes.

Fidelity evaluation of video-taped exercise sessions for first and last cohorts in the intervention (all sessions for first and last 4-5 individuals forming a group) will be conducted. A rating of physiotherapist compliance and participant uptake and descriptive feedback will be obtained. Fidelity rating forms (designed in-house by the study team) were filled out for the individual session (e.g., purpose and aims of LiFE program explained) and group sessions (e.g., PT demonstrated the activity to the group and identified situations to embed the activity). Each program criterion was scored out of 2 (0 = not done at all, 1 = done but could be better, 2 = done well) for 34 criteria for the individual session (sum of scores expressed out of 68) and 17 criteria for the group sessions (sum of scores expressed out of 34) with any disagreement resolved via third-party.

Outcome measures

Measure	Lifestyle-integrated Functional Exercise n=47 Participants Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session
Sum of Scores on Fidelity Rating Forms - Individual and Group Sessions Individual Session	62 total score on a scale
Sum of Scores on Fidelity Rating Forms - Individual and Group Sessions Group Session	33 total score on a scale

SECONDARY outcome

Timeframe: 6 months

Population: Note: 1 participant did not agree to data collection for secondary outcomes

Barriers and facilitators to implementation from the perspectives of the participants were identified using in-person or teleconference semi-structured interviews. Semi-structured interviews were conducted in-person with the participants at the 6-month follow-up time-point. The interviews with the participants included open-ended questions to understand their experience and level of satisfaction with the program (reasons for joining the program, observed benefits, areas for improvement, what they liked/disliked, general strategies for physical activity PA).

Outcome measures

Measure	Lifestyle-integrated Functional Exercise n=47 Participants Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session
Number of Participants Who Provided Feedback on the Barriers and Facilitators to the Implementation of the Exercise Program	47 participants

SECONDARY outcome

Timeframe: Baseline, 6 months

The TFEQ-R21 questionnaire will be administered at Study Visit #1 (baseline), Exercise Session #1, and Study Visit #2 (6 month follow-up) as measures of eating behaviours, including cognitive restraint, uncontrolled eating, and emotional eating. The test-retest reliability of the TFEQ-R21 as a measure of eating behaviour in older adults aged 75 years or older will also be examined to determine consistency and stability of the instrument in the sample population. Subscale scores could range from 0 to 100 with higher scores indicating higher cognitive restraint.

Outcome measures

Measure	Lifestyle-integrated Functional Exercise n=32 Participants Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session
Change in TFEQ-R21 Score- Cognitive Restraint Subscale Cognitive restraint score - Baseline	16.0 score on a scale Standard Deviation 18.1
Change in TFEQ-R21 Score- Cognitive Restraint Subscale Cognitive restraint score - 6 months	16.9 score on a scale Standard Deviation 20.9

SECONDARY outcome

Timeframe: Baseline, 6 months

The TFEQ-R21 questionnaire will be administered at Study Visit #1 (baseline), Exercise Session #1, and Study Visit #2 (6 month follow-up) as measures of eating behaviours, including cognitive restraint, uncontrolled eating, and emotional eating. The test-retest reliability of the TFEQ-R21 as a measure of eating behaviour in older adults aged 75 years or older will also be examined to determine consistency and stability of the instrument in the sample population. Subscale scores could range from 0 to 100 with higher scores indicating higher uncontrolled eating behaviour.

Outcome measures

Measure	Lifestyle-integrated Functional Exercise n=32 Participants Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session
Change in TFEQ-R21 Score - Uncontrolled Eating Subscale Uncontrolled eating score - Baseline	45.5 score on a scale Standard Deviation 30.0
Change in TFEQ-R21 Score - Uncontrolled Eating Subscale Uncontrolled eating score - 6 months	45.5 score on a scale Standard Deviation 23.5

SECONDARY outcome

Timeframe: Baseline, 6 months

The TFEQ-R21 questionnaire will be administered at Study Visit #1 (baseline), Exercise Session #1, and Study Visit #2 (6 month follow-up) as measures of eating behaviours, including cognitive restraint, uncontrolled eating, and emotional eating. The test-retest reliability of the TFEQ-R21 as a measure of eating behaviour in older adults aged 75 years or older will also be examined to determine consistency and stability of the instrument in the sample population. Subscale scores could range from 0 to 100 with high scores indicating higher emotional eating behaviour.

Outcome measures

Measure	Lifestyle-integrated Functional Exercise n=32 Participants Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session
Change in TFEQ-R21 Score - Emotional Eating Behaviour Subscale Emotional eating score - Baseline	15.5 score on a scale Standard Deviation 23.1
Change in TFEQ-R21 Score - Emotional Eating Behaviour Subscale Emotional eating score - 6 months	14.3 score on a scale Standard Deviation 20.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Number of intervention sessions attended by participation

Outcome measures

Measure	Lifestyle-integrated Functional Exercise n=48 Participants Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session
Session Attendance 3-4 sessions	8 Participants
Session Attendance Withdrew prior to program	4 Participants
Session Attendance 1-2 sessions	7 Participants
Session Attendance 5 sessions	29 Participants

POST_HOC outcome

Timeframe: 6 months

Population: Participants that enrolled in the intervention only

Adherence is defined as the number of days each week that the participant completes/integrates strength and balance activities into daily tasks. Adherence will be 100% if participants complete the balance and strength activities at least 3 days per week.

Outcome measures

Measure	Lifestyle-integrated Functional Exercise n=44 Participants Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session
Adherence (Excluding Withdrawals) Weeks 1-8	27 Participants
Adherence (Excluding Withdrawals) Weeks 9-16	25 Participants
Adherence (Excluding Withdrawals) Weeks 17-24	22 Participants

Adverse Events

Lifestyle-integrated Functional Exercise

Serious events: 5 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lifestyle-integrated Functional Exercise n=48 participants at risk Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session. Lifestyle-integrated Functional Exercise: Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session.
Metabolism and nutrition disorders Infection in big toe secondary to diabetes	2.1% 1/48 • Number of events 1 • 6 months
Respiratory, thoracic and mediastinal disorders Worsening of COPD symptoms	2.1% 1/48 • Number of events 1 • 6 months
Cardiac disorders Severe chest/abdominal pain	2.1% 1/48 • Number of events 1 • 6 months
Metabolism and nutrition disorders Diabetic episode	2.1% 1/48 • Number of events 1 • 6 months
Vascular disorders Intracerebral hemorrhage	2.1% 1/48 • Number of events 1 • 6 months

Other adverse events

Measure	Lifestyle-integrated Functional Exercise n=48 participants at risk Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session. Lifestyle-integrated Functional Exercise: Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session.
Musculoskeletal and connective tissue disorders Heel pain	2.1% 1/48 • Number of events 1 • 6 months
Musculoskeletal and connective tissue disorders Hamstring strain	2.1% 1/48 • Number of events 1 • 6 months
Infections and infestations Pneumonia/flu	4.2% 2/48 • Number of events 2 • 6 months
Musculoskeletal and connective tissue disorders Chronic leg pain	4.2% 2/48 • Number of events 2 • 6 months
Injury, poisoning and procedural complications Fall-related injury	4.2% 2/48 • Number of events 2 • 6 months
Musculoskeletal and connective tissue disorders Low back pain	2.1% 1/48 • Number of events 1 • 6 months
Cardiac disorders Racing heart rate	2.1% 1/48 • Number of events 1 • 6 months
Musculoskeletal and connective tissue disorders Strained rotator cuff	2.1% 1/48 • Number of events 1 • 6 months
Musculoskeletal and connective tissue disorders Hip tendonitis	2.1% 1/48 • Number of events 1 • 6 months
Nervous system disorders Dementia diagnosis	2.1% 1/48 • Number of events 1 • 6 months
Musculoskeletal and connective tissue disorders Heel spur	2.1% 1/48 • Number of events 1 • 6 months

Additional Information

Dr. Lora Giangregorio

University of Waterloo

Phone: 519-888-4567

Email: lora.giangregorio@uwaterloo.ca

Results disclosure agreements

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