Clinical trial NCT02732366: Living in Fitness Together (LIFT): Testing an Innovative Fall Prevention Program
Official title: Living in Fitness Together (LIFT): Testing an Innovative Fall Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Falls
Keywords: aged [MeSH term]
exercise [MeSH term]
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Mt. Ascutney Hospital and Health Center
name: Foundation for Physical Therapy, Inc.
name: Boston University
First posted: 2016-04-08
Enrollment: 48
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Enrollment
timeFrame: 6 months
measure: Intervention and Control Group Program Attendance
timeFrame: 6 weeks
measure: Program Completion
timeFrame: 6 weeks
measure: Adverse Events
timeFrame: 6 months
measure: Adverse Events - Number of Events
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Windsor
country: United States
facility: Mount Ascutney Hospital and Health Center
state: Vermont
Study officials:
affiliation: University of Pittsburgh, School of Health and Rehabilitation Sciences, Department of Physical Therapy
name: Christine M McDonough, PT, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1136/ip.2005.011015.
citation: 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.