Accidental Falls
Conditions
Keywords
aged [MeSH term], exercise [MeSH term]
Brief summary
The purpose of this study is to test the feasibility and preliminary efficacy of a group-based fall prevention program for older adults.
Detailed description
Falls are the leading cause of non-fatal and fatal injuries in older adults. The number of fall-related older adult deaths in 2005 reached 15,802. Overall, thirty percent of adults over the age of 65 fall every year, and the risk for falls increases dramatically with age. Direct medical costs related to falls reached $19 billion in 2000. In 2006 a national study found that 5.8 million older adults (16%) reported a fall in the prior 3 month period and 1.8 million had been injured. Falls and fall-related injuries have an important impact on mobility, functioning, and the quality of life of older adults, and for many, result in catastrophic mobility decline, loss of independence and institutionalization. The trends in falls and aging in the population make this a critical problem for our time. Current evidence and guidelines recommend assessment of several important risk factors and providing individualized intervention for older adults at increased risk of falls. Strength, balance and gait training are among the most potent intervention elements. Evidence shows that fall risk benefits gained from exercise are completely lost within 12 weeks if exercise is not continued. Therefore, persistence with exercise and physical activity are critical to the long-term success of fall prevention treatments. The proposed project tests the feasibility and preliminary efficacy of an innovative group-based fall prevention program called Living In Fitness Together (LIFT). The program consists of group-based physical therapy for strength, balance, mobility and flexibility training, an individualized home program including walking for physical activity, and training of the group members to support and coach each other toward meeting their exercise and physical activity goals. It consists of 8 group sessions over 6 weeks plus one group booster session delivered by a physical therapist, occupational therapist and trained staff. The program is designed to deliver progressive, tailored, and challenging exercise intervention for older adults at risk for falls and empower older adults to meet their goals for exercise and physical activity through training in self-management, and peer-coaching within the exercise group. The aim of this project is to test the feasibility of implementing the fall prevention program with peer-coaching in the context of physical therapy practice, and to assess its safety and initial efficacy. The results of this study will be the foundation of a formal clinical trial of a novel program of exercise and peer- coaching for exercise adherence. This program has potential to be incorporated into physical therapy practice and disseminated widely, and to have an important impact on the number of falls and fall-related injuries that occur in older adults.
Interventions
BEHAVIORALGroup-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.
OTHERUsual 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).
Sponsors
Mt. Ascutney Hospital and Health Center
Foundation for Physical Therapy, Inc.
Boston University
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* adults aged 65 and over * at risk for falls as identified by health care provider * able to participate in group exercise with upper extremity support for balance (e.g. chair)
Exclusion criteria
* active vertigo, postural hypotension, unstable cardiac conditions * major neurological disorders such as Parkinson's disease, recent major cerebrovascular event, multiple sclerosis, amyotrophic lateral sclerosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment | 6 months | 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. |
| Intervention and Control Group Program Attendance | 6 weeks | To assess feasibility of the intervention, the percentage of sessions attended by patients enrolled in the study will be collected. |
| Program Completion | 6 weeks | To assess feasibility of the intervention, the number of patients who complete the program will be collected. |
| Adverse Events | 6 months | To assess safety of the intervention, patients will be instructed to report all adverse events to the clinical investigators. |
| Adverse Events - Number of Events | 6 months | Number of Adverse Events |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Two participants withdrew after consenting and before randomization. Note that randomization was done in session blocks.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| 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). | 21 |
| Total | 39 |
Baseline characteristics
| Characteristic | Total | Usual PT and Attention Control Grp Class | Group-based Exercise and Peer Coaching |
|---|---|---|---|
| 30 Second Chair Stand | 8.56 number of stands STANDARD_DEVIATION 3.74 | 8.24 number of stands STANDARD_DEVIATION 4.1 | 8.89 number of stands STANDARD_DEVIATION 3.5 |
| Age, Continuous | 76.4 years STANDARD_DEVIATION 6.17 | 77.2 years STANDARD_DEVIATION 6.7 | 75.6 years STANDARD_DEVIATION 5.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 38 Participants | 20 Participants | 18 Participants |
| Region of Enrollment United States | 39 participants | 21 participants | 18 participants |
| Sex: Female, Male Female | 26 Participants | 13 Participants | 13 Participants |
| Sex: Female, Male Male | 12 Participants | 7 Participants | 5 Participants |
| Timed Up and Go (seconds) | 14.65 seconds STANDARD_DEVIATION 6.57 | 16.7 seconds STANDARD_DEVIATION 9 | 12.6 seconds STANDARD_DEVIATION 2.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 21 |
| other Total, other adverse events | 10 / 18 | 10 / 21 |
| serious Total, serious adverse events | 0 / 18 | 2 / 21 |
Outcome results
Primary
Adverse Events
To assess safety of the intervention, patients will be instructed to report all adverse events to the clinical investigators.
Time frame: 6 months
Population: Participants in the intervention and control groups
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Screened Population | Adverse Events | Number of Participants with AEs | 10 Participants |
| Screened Population | Adverse Events | Number of Participants with falls | 10 Participants |
| Usual PT and Attention Control Grp Class | Adverse Events | Number of Participants with AEs | 10 Participants |
| Usual PT and Attention Control Grp Class | Adverse Events | Number of Participants with falls | 9 Participants |
Primary
Adverse Events - Number of Events
Number of Adverse Events
Time frame: 6 months
Population: Number of Adverse Events
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Screened Population | Adverse Events - Number of Events | Falls | 14 number of events |
| Screened Population | Adverse Events - Number of Events | All non-fall adverse events | 1 number of events |
| Usual PT and Attention Control Grp Class | Adverse Events - Number of Events | Falls | 13 number of events |
| Usual PT and Attention Control Grp Class | Adverse Events - Number of Events | All non-fall adverse events | 4 number of events |
Primary
Enrollment
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.
Time frame: 6 months
Population: 342 older adults were screened for eligibility.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Screened Population | Enrollment | Screened | 342 participants |
| Screened Population | Enrollment | Did not meet inclusion criteria | 142 participants |
| Screened Population | Enrollment | Met at least one exclusion criterion met | 23 participants |
| Screened Population | Enrollment | Eligible | 177 participants |
| Screened Population | Enrollment | Not interested | 101 participants |
| Screened Population | Enrollment | Unable to attend sessions | 25 participants |
| Screened Population | Enrollment | Could not be reached | 3 participants |
| Screened Population | Enrollment | Enrolled | 48 participants |
Primary
Intervention and Control Group Program Attendance
To assess feasibility of the intervention, the percentage of sessions attended by patients enrolled in the study will be collected.
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Screened Population | Intervention and Control Group Program Attendance | 85.5 percentage of sessions |
| Usual PT and Attention Control Grp Class | Intervention and Control Group Program Attendance | 95.0 percentage of sessions |
Primary
Program Completion
To assess feasibility of the intervention, the number of patients who complete the program will be collected.
Time frame: 6 weeks
Population: The number of participants that attended 6 week program (non-withdrawals).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Screened Population | Program Completion | 18 number of participants |
| Usual PT and Attention Control Grp Class | Program Completion | 20 number of participants |