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Clinical Trials/NCT02732366
NCT02732366CompletedNot Applicable

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

University of Pittsburgh1 site in 1 country48 target enrollmentStarted: May 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
48
Locations
1
Primary Endpoint
Intervention and Control Group Program Attendance

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to 99 Years (Older Adult)
Sex
All
Accepts 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

Arms & Interventions

Group-based exercise and peer coaching

Experimental

This treatment arm will include physical therapist-led group-based exercise, goal-setting, peer coaching training, individualized home program, and activity monitoring.

Intervention: Group-based exercise and peer coaching (Behavioral)

Usual PT and attention control grp class

Active Comparator

This arm consists of the continuation of one-on-one PT along with participation in an attention control - healthy living class.

Intervention: Usual PT and attention control grp class (Other)

Outcomes

Primary Outcomes

Intervention and Control Group Program Attendance

Time Frame: 6 weeks

To assess feasibility of the intervention, the percentage of sessions attended by patients enrolled in the study will be collected.

Program Completion

Time Frame: 6 weeks

To assess feasibility of the intervention, the number of patients who complete the program will be collected.

Adverse Events - Number of Events

Time Frame: 6 months

Number of Adverse Events

Enrollment

Time Frame: 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

Time Frame: 6 months

To assess safety of the intervention, patients will be instructed to report all adverse events to the clinical investigators.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Christine McDonough

Assistant Professor of Physical Therapy

University of Pittsburgh

Study Sites (1)

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