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

May 4, 2020 updated by: Christine McDonough, University of Pittsburgh
The purpose of this study is to test the feasibility and preliminary efficacy of a group-based fall prevention program for older adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Vermont
      • Windsor, Vermont, United States, 05089
        • Mount Ascutney Hospital and Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 99 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
Active Comparator: 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.
Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 weeks
Program Completion
Time Frame: 6 weeks
To assess feasibility of the intervention, the number of patients who complete the program will be collected.
6 weeks
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.
6 months
Adverse Events - Number of Events
Time Frame: 6 months
Number of Adverse Events
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

Boston University
Foundation for Physical Therapy, Inc.
Mt. Ascutney Hospital and Health Center

Investigators

  • Principal Investigator: Christine M McDonough, PT, MS, PhD, University of Pittsburgh, School of Health and Rehabilitation Sciences, Department of Physical Therapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

March 25, 2019

Study Completion (Actual)

March 25, 2019

Study Registration Dates

First Submitted

March 24, 2016

First Submitted That Met QC Criteria

April 4, 2016

First Posted (Estimate)

April 8, 2016

Study Record Updates

Last Update Posted (Actual)

May 12, 2020

Last Update Submitted That Met QC Criteria

May 4, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PRO18020039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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