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

NCT02732366 | Completed Results

• 1 other identifier: PRO18020039
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Accidental Falls

Keywords

aged [MeSH term]; exercise [MeSH term]

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• Program Completion

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

  6 weeks

• Adverse Events

  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

  Number of Adverse Events

  6 months

Study Arms (2)

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.

Behavioral: Group-based exercise and peer coaching

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.

Other: Usual PT and attention control grp class

Interventions

Group-based exercise and peer coaching 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.

Group-based exercise and peer coaching

Usual PT and attention control grp class 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).

Usual PT and attention control grp class

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• active vertigo, postural hypotension, unstable cardiac conditions
• major neurological disorders such as Parkinson's disease, recent major cerebrovascular event, multiple sclerosis, amyotrophic lateral sclerosis

Sponsors & Collaborators

• University of Pittsburgh: lead
• Mt. Ascutney Hospital and Health Center: collaborator
• Foundation for Physical Therapy, Inc.: collaborator
• Boston University: collaborator

Study Sites (1)

Mount Ascutney Hospital and Health Center

Windsor, Vermont, 05089, United States

Location

Related Publications (2)

• 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.

  PMID: 17018668 BACKGROUND

• 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.

  PMID: 22868837 BACKGROUND

Related 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

Results Point of Contact

• Title: Christine M. McDonough, Assistant Professor of Physical Therapy
• Organization: University of Pittsburgh, Department of Physical Therapy

cmm295@pitt.edu

4123834603

Study Officials

• Christine M McDonough, PT, MS, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physical Therapy

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: April 8, 2016
• Study Start: May 1, 2016
• Primary Completion: March 25, 2019
• Study Completion: March 25, 2019
• Last Updated: May 12, 2020
• Results First Posted: May 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)