Trial Outcomes & Findings for Living in Fitness Together (LIFT): Testing an Innovative Fall Prevention Program (NCT NCT02732366)
NCT ID: NCT02732366
Last Updated: 2020-05-12
Results Overview
To assess feasibility of the intervention, the number of patients identified as eligible, the number who refuse to participate, and the number who enroll in the study will be collected.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
6 months
Results posted on
2020-05-12
Participant Flow
Participants were recruited from physician and physical therapist practices in a rural regional hospital. The intervention and control conditions were provided as 8-week programs. Recruitment was coordinated to occur approximately 4 weeks prior to a scheduled program/session, until sufficient numbers of participants were identified.
Two participants withdrew after consenting and before randomization. Note that randomization was done in session blocks.
Participant milestones
| Measure |
Group-based Exercise and Peer Coaching
This treatment arm will include physical therapist-led group-based exercise, goal-setting, peer coaching training, individualized home program, and activity monitoring.
Group-based exercise and peer coaching: Group-based exercise and peer coaching will take place over 6 weeks plus one booster visit after 3 months, and include physical therapist-led 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions) to include: progressive strengthening, balance and mobility exercises; patient goal setting; peer coaching training activities to teach group members ways to help each other to meet their exercise goals during and after classes are over. There will be an individualized home program including flexibility, strengthening, walking, and balance, as well as activity monitoring.
|
Usual PT and Attention Control Grp Class
This arm consists of the continuation of one-on-one PT along with participation in an attention control - healthy living class.
Usual PT and attention control grp class: The usual PT and attention control group class will receive standard one-on-one PT strength, balance, gait and education intervention, and group classes to provide valuable information about healthy living, including nutrition, relaxation, and stress management. The attention control - healthy living group classes will take place over 6 weeks plus one booster visit after 3 months, and include 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions).
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
Withdrawal by Participant
|
5
|
2
|
|
Overall Study
COMPLETED
|
18
|
21
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
missing: 1
Baseline characteristics by cohort
| Measure |
Group-based Exercise and Peer Coaching
n=18 Participants
This treatment arm will include physical therapist-led group-based exercise, goal-setting, peer coaching training, individualized home program, and activity monitoring.
Group-based exercise and peer coaching: Group-based exercise and peer coaching will take place over 6 weeks plus one booster visit after 3 months, and include physical therapist-led 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions) to include: progressive strengthening, balance and mobility exercises; patient goal setting; peer coaching training activities to teach group members ways to help each other to meet their exercise goals during and after classes are over. There will be an individualized home program including flexibility, strengthening, walking, and balance, as well as activity monitoring.
|
Usual PT and Attention Control Grp Class
n=21 Participants
This arm consists of the continuation of one-on-one PT along with participation in an attention control - healthy living class.
Usual PT and attention control grp class: The usual PT and attention control group class will receive standard one-on-one PT strength, balance, gait and education intervention, and group classes to provide valuable information about healthy living, including nutrition, relaxation, and stress management. The attention control - healthy living group classes will take place over 6 weeks plus one booster visit after 3 months, and include 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions).
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.6 years
STANDARD_DEVIATION 5.6 • n=18 Participants
|
77.2 years
STANDARD_DEVIATION 6.7 • n=21 Participants
|
76.4 years
STANDARD_DEVIATION 6.17 • n=39 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=18 Participants • missing: 1
|
13 Participants
n=20 Participants • missing: 1
|
26 Participants
n=38 Participants • missing: 1
|
|
Sex: Female, Male
Male
|
5 Participants
n=18 Participants • missing: 1
|
7 Participants
n=20 Participants • missing: 1
|
12 Participants
n=38 Participants • missing: 1
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=18 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=18 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=18 Participants
|
20 Participants
n=21 Participants
|
38 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=18 Participants
|
21 participants
n=21 Participants
|
39 participants
n=39 Participants
|
|
Timed Up and Go (seconds)
|
12.6 seconds
STANDARD_DEVIATION 2.3 • n=18 Participants
|
16.7 seconds
STANDARD_DEVIATION 9.0 • n=21 Participants
|
14.65 seconds
STANDARD_DEVIATION 6.57 • n=39 Participants
|
|
30 Second Chair Stand
|
8.89 number of stands
STANDARD_DEVIATION 3.5 • n=18 Participants
|
8.24 number of stands
STANDARD_DEVIATION 4.1 • n=21 Participants
|
8.56 number of stands
STANDARD_DEVIATION 3.74 • n=39 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 342 older adults were screened for eligibility.
To assess feasibility of the intervention, the number of patients identified as eligible, the number who refuse to participate, and the number who enroll in the study will be collected.
Outcome measures
| Measure |
Screened Population
n=342 Participants
Number screened
|
Usual PT and Attention Control Grp Class
Attendance to 6 control group sessions for 6 groups
|
|---|---|---|
|
Enrollment
Screened
|
342 participants
|
—
|
|
Enrollment
Did not meet inclusion criteria
|
142 participants
|
—
|
|
Enrollment
Met at least one exclusion criterion met
|
23 participants
|
—
|
|
Enrollment
Eligible
|
177 participants
|
—
|
|
Enrollment
Not interested
|
101 participants
|
—
|
|
Enrollment
Unable to attend sessions
|
25 participants
|
—
|
|
Enrollment
Could not be reached
|
3 participants
|
—
|
|
Enrollment
Enrolled
|
48 participants
|
—
|
PRIMARY outcome
Timeframe: 6 weeksTo assess feasibility of the intervention, the percentage of sessions attended by patients enrolled in the study will be collected.
Outcome measures
| Measure |
Screened Population
n=18 Participants
Number screened
|
Usual PT and Attention Control Grp Class
n=21 Participants
Attendance to 6 control group sessions for 6 groups
|
|---|---|---|
|
Intervention and Control Group Program Attendance
|
85.5 percentage of sessions
|
95.0 percentage of sessions
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: The number of participants that attended 6 week program (non-withdrawals).
To assess feasibility of the intervention, the number of patients who complete the program will be collected.
Outcome measures
| Measure |
Screened Population
n=18 Participants
Number screened
|
Usual PT and Attention Control Grp Class
n=21 Participants
Attendance to 6 control group sessions for 6 groups
|
|---|---|---|
|
Program Completion
|
18 number of participants
|
20 number of participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Participants in the intervention and control groups
To assess safety of the intervention, patients will be instructed to report all adverse events to the clinical investigators.
Outcome measures
| Measure |
Screened Population
n=18 Participants
Number screened
|
Usual PT and Attention Control Grp Class
n=21 Participants
Attendance to 6 control group sessions for 6 groups
|
|---|---|---|
|
Adverse Events
Number of Participants with AEs
|
10 Participants
|
10 Participants
|
|
Adverse Events
Number of Participants with falls
|
10 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Number of Adverse Events
Number of Adverse Events
Outcome measures
| Measure |
Screened Population
n=18 Participants
Number screened
|
Usual PT and Attention Control Grp Class
n=21 Participants
Attendance to 6 control group sessions for 6 groups
|
|---|---|---|
|
Adverse Events - Number of Events
Falls
|
14 number of events
|
13 number of events
|
|
Adverse Events - Number of Events
All non-fall adverse events
|
1 number of events
|
4 number of events
|
Adverse Events
Group-based Exercise and Peer Coaching
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Usual PT and Attention Control Grp Class
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group-based Exercise and Peer Coaching
n=18 participants at risk
This treatment arm will include physical therapist-led group-based exercise, goal-setting, peer coaching training, individualized home program, and activity monitoring.
Group-based exercise and peer coaching: Group-based exercise and peer coaching will take place over 6 weeks plus one booster visit after 3 months, and include physical therapist-led 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions) to include: progressive strengthening, balance and mobility exercises; patient goal setting; peer coaching training activities to teach group members ways to help each other to meet their exercise goals during and after classes are over. There will be an individualized home program including flexibility, strengthening, walking, and balance, as well as activity monitoring.
|
Usual PT and Attention Control Grp Class
n=21 participants at risk
This arm consists of the continuation of one-on-one PT along with participation in an attention control - healthy living class.
Usual PT and attention control grp class: The usual PT and attention control group class will receive standard one-on-one PT strength, balance, gait and education intervention, and group classes to provide valuable information about healthy living, including nutrition, relaxation, and stress management. The attention control - healthy living group classes will take place over 6 weeks plus one booster visit after 3 months, and include 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions).
|
|---|---|---|
|
Cardiac disorders
heart attack
|
0.00%
0/18 • From baseline to 6 months from baseline
Although falls were expected in this study, they were collected.
|
4.8%
1/21 • Number of events 1 • From baseline to 6 months from baseline
Although falls were expected in this study, they were collected.
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/18 • From baseline to 6 months from baseline
Although falls were expected in this study, they were collected.
|
4.8%
1/21 • Number of events 1 • From baseline to 6 months from baseline
Although falls were expected in this study, they were collected.
|
Other adverse events
| Measure |
Group-based Exercise and Peer Coaching
n=18 participants at risk
This treatment arm will include physical therapist-led group-based exercise, goal-setting, peer coaching training, individualized home program, and activity monitoring.
Group-based exercise and peer coaching: Group-based exercise and peer coaching will take place over 6 weeks plus one booster visit after 3 months, and include physical therapist-led 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions) to include: progressive strengthening, balance and mobility exercises; patient goal setting; peer coaching training activities to teach group members ways to help each other to meet their exercise goals during and after classes are over. There will be an individualized home program including flexibility, strengthening, walking, and balance, as well as activity monitoring.
|
Usual PT and Attention Control Grp Class
n=21 participants at risk
This arm consists of the continuation of one-on-one PT along with participation in an attention control - healthy living class.
Usual PT and attention control grp class: The usual PT and attention control group class will receive standard one-on-one PT strength, balance, gait and education intervention, and group classes to provide valuable information about healthy living, including nutrition, relaxation, and stress management. The attention control - healthy living group classes will take place over 6 weeks plus one booster visit after 3 months, and include 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.00%
0/18 • From baseline to 6 months from baseline
Although falls were expected in this study, they were collected.
|
4.8%
1/21 • Number of events 1 • From baseline to 6 months from baseline
Although falls were expected in this study, they were collected.
|
|
Musculoskeletal and connective tissue disorders
spine disorder
|
0.00%
0/18 • From baseline to 6 months from baseline
Although falls were expected in this study, they were collected.
|
4.8%
1/21 • Number of events 1 • From baseline to 6 months from baseline
Although falls were expected in this study, they were collected.
|
|
Gastrointestinal disorders
colitis
|
5.6%
1/18 • Number of events 1 • From baseline to 6 months from baseline
Although falls were expected in this study, they were collected.
|
0.00%
0/21 • From baseline to 6 months from baseline
Although falls were expected in this study, they were collected.
|
|
General disorders
Falls
|
55.6%
10/18 • Number of events 14 • From baseline to 6 months from baseline
Although falls were expected in this study, they were collected.
|
42.9%
9/21 • Number of events 13 • From baseline to 6 months from baseline
Although falls were expected in this study, they were collected.
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/18 • From baseline to 6 months from baseline
Although falls were expected in this study, they were collected.
|
4.8%
1/21 • Number of events 1 • From baseline to 6 months from baseline
Although falls were expected in this study, they were collected.
|
Additional Information
Christine M. McDonough, Assistant Professor of Physical Therapy
University of Pittsburgh, Department of Physical Therapy
Phone: 4123834603
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place