Living in Fitness Together (LIFT): Testing an Innovative Fall Prevention Program

Not Applicable

Completed

• Conditions: Accidental Falls
• Interventions: Behavioral: Group-based exercise and peer coaching; Other: Usual PT and attention control grp class

• Registration Number: NCT02732366
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study First Submitted: 2016-03-24
• Study First Submitted QC: 2016-04-04
• Study First Posted: 2016-04-08
• Study Start: 2016-05
• Primary Completion: 2019-03-25
• Study Completion: 2019-03-25
• Results First Submitted: 2020-03-26
• Status Verified: 2020-05
• Results First Submitted QC: 2020-05-04
• Last Update Submitted: 2020-05-04
• Results First Posted: 2020-05-12
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group-based exercise and peer coaching	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.
Usual PT and attention control grp class	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.

Primary Outcome Measures

Name	Time	Method
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 - Number of Events	6 months	Number of Adverse Events
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.
Adverse Events	6 months	To assess safety of the intervention, patients will be instructed to report all adverse events to the clinical investigators.

Trial Locations

Locations (1)

Mount Ascutney Hospital and Health Center; 🇺🇸 Windsor, Vermont, United States