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

NCT ID: NCT02732366

Last Updated: 2020-05-12

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2019-03-25

Brief Summary

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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

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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.

Conditions

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Accidental Falls

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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 Type EXPERIMENTAL

Group-based exercise and peer coaching

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Usual PT and attention control grp class

Intervention Type OTHER

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).

Interventions

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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.

Intervention Type BEHAVIORAL

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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mt. Ascutney Hospital and Health Center

OTHER

Sponsor Role collaborator

Foundation for Physical Therapy, Inc.

INDUSTRY

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Christine McDonough

Assistant Professor of Physical Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christine M McDonough, PT, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh, School of Health and Rehabilitation Sciences, Department of Physical Therapy

Locations

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Mount Ascutney Hospital and Health Center

Windsor, Vermont, United States

Site Status

Countries

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United States

References

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Stevens JA, Corso PS, Finkelstein EA, Miller TR. The costs of fatal and non-fatal falls among older adults. Inj Prev. 2006 Oct;12(5):290-5. doi: 10.1136/ip.2005.011015.

Reference Type BACKGROUND
PMID: 17018668 (View on PubMed)

Moyer VA; U.S. Preventive Services Task Force. Prevention of falls in community-dwelling older adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012 Aug 7;157(3):197-204. doi: 10.7326/0003-4819-157-3-201208070-00462.

Reference Type BACKGROUND
PMID: 22868837 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

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http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5545a1.htm

Fatalities and injuries from falls among older adults - US 1993-2003 and 2001-2005. Morbidity and mortality weekly report. 2006

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5709a1.htm

Self-reported falls and fall-related injuries among persons aged \>65 years - US, 2006. Morbidity and mortality weekly report. 2008

Other Identifiers

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PRO18020039

Identifier Type: -

Identifier Source: org_study_id

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