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

Accidental Falls Clinical Trial

— LIFT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02732366
• Other study ID #: PRO18020039
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: March 25, 2019

Study information

• Verified date: May 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the feasibility and preliminary efficacy of a group-based fall prevention program for older adults.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 25, 2019
• Est. primary completion date: March 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Accidental Falls

Intervention

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.

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).

Locations

Country	Name	City	State
United States	Mount Ascutney Hospital and Health Center	Windsor	Vermont

Sponsors (4)

Lead Sponsor	Collaborator
University of Pittsburgh	Boston University, Foundation for Physical Therapy, Inc., Mt. Ascutney Hospital and Health Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	6 months
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.	6 weeks
Primary	Program Completion	To assess feasibility of the intervention, the number of patients who complete the program will be collected.	6 weeks
Primary	Adverse Events	To assess safety of the intervention, patients will be instructed to report all adverse events to the clinical investigators.	6 months
Primary	Adverse Events - Number of Events	Number of Adverse Events	6 months

External Links

•   Fatalities and injuries from falls among older adults - US 1993-2003 and 2001-2005. Morbidity and mortality weekly report. 2006
•   Self-reported falls and fall-related injuries among persons aged >65 years - US, 2006. Morbidity and mortality weekly report. 2008