Efficacy of a Post-Rehabilitation Exercise Intervention

NCT00592813 | Completed DMC

• 2 other identifiers: NINR 1R01NR010815-01A21R01NR010815-01A2
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Many people who have suffered a hip fracture are discharged from rehabilitation services with significant residual functional limitations and disability. We believe that a home-based exercise program that incorporates cognitive-behavioral techniques to increase exercise adherence and promote the return to daily activities could extend the benefits of formal rehabilitation for patients who have suffered a hip fracture. Specific Aims: We will conduct a 5-year multi-site randomized controlled trial in patients who have suffered a recent hip fracture and have completed all rehabilitation services. The specific aim that this project will address is whether: Participation in the Strong for Life (SFL) program will improve function and disability outcomes in participants 6-months after they are discharged from rehabilitation services. This study will also investigate the following secondary hypotheses:

• T0: baseline, at the point of discharge from formal rehabilitation;
• T2: 6-month outcome assessment
• T3: 9-month follow-up Outcomes: The primary outcomes will be function measured by both self-report (AM PAC) and physical performance measures (SPPB). Secondary outcomes include disability, self-efficacy, balance, strength, cognition, and reaction time. Adherence to the exercise program and adverse events will also be monitored.

Conditions

Hip Fracture; Disability

Keywords

rehabilitation; function

Outcome Measures

Primary Outcomes (1)

• The specific aim that this project will address is whether: Participation in the SFL program will improve function and disability outcomes in participants 6-months after they are discharged from rehabilitation services.

  performance based function is assessed using the Short Physical Performance Battery (SPPB) and self-reported function is assessed using the AM-PAC

  baseline, 6-month and 9-month follow up

Secondary Outcomes (2)

• Changes in function and disability at 6-month follow-up will be correlated with changes in all three proposed intermediary variables: muscle strength, balance, and self-efficacy.

  baseline, 6-month and 9-month follow up

• At 9-month follow-up the SFL program will continue to have a significant impact on participants' function and disability compared to the control group.

  baseline, 6-month and 9-month follow up

Study Arms (2)

1

EXPERIMENTAL

Behavioral: Enhanced Strong for Life

cardiovascular education (attention control)

PLACEBO COMPARATOR

Behavioral: cardiovascular nutrition education

Interventions

Enhanced Strong for Life BEHAVIORAL

The program contains 5 minutes of warm-up, 25 minutes of strengthening, and 5 minutes of cool-down exercises. The SFL program is contained on a 35 minute videotape. Subjects are instructed to increase resistance when they can perform 10 repetitions of a movement pattern without significant fatigue or loss of proper execution. Subjects are instructed to move within a comfortable range of motion. Participants will be taught the SFL program during two home visits conducted by a physical therapist. On the first visit, the exercise techniques will be taught, modified as needed based on individual needs and practiced as necessary until proper technique is attained. Each participant will be given written guidelines for how to progress resistance of the program, how to modify the exercises and how to complete bimonthly exercise calendars.

1

cardiovascular nutrition education BEHAVIORAL

administered as an attention control intervention using home visits, phone calls and mail-outs of information

cardiovascular education (attention control)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a primary diagnosis of hip fracture;
• Aged 60 years and above;
• Have functional limitation (i.e., as determined by limitation in at least one of 9 functional tasks listed in the SF-36 physical function scale, excluding vigorous activities);
• Have recently been discharged from rehabilitation services;
• Be able to understand and communicate in English;
• Be able to safely and independently stand with or without the aid of a mobility device, without needing any assistance or supervision from another person;
• Have received written clearance from their primary care physician documenting no contra-indications for participating in the study;
• Be able to provide written informed consent.

You may not qualify if:

• Have serious cognitive deficits (i.e., a Mini-Mental State Examination score of less than 20)85;
• Have severe depression (i.e., a score of 20 or greater on the Geriatric Depression Scale)86;
• Have a terminal illness with survival expected to be less than 1 year;
• Have significant pulmonary or cardiovascular contraindications or pre-existing conditions that preclude participating in an exercise program;
• Legally blind;
• Currently receiving rehabilitation therapy;
• Live outside of the study's catchment area in the Boston metropolitan area and eastern Massachusetts.

Sponsors & Collaborators

• Boston University: lead
• National Institute of Nursing Research (NINR): collaborator
• Spaulding Rehabilitation Hospital: collaborator

Study Sites (1)

Spaulding Rehabilitation Hospital

Cambridge, Massachusetts, 02138, United States

Location

Related Publications (1)

• Latham NK, Harris BA, Bean JF, Heeren T, Goodyear C, Zawacki S, Heislein DM, Mustafa J, Pardasaney P, Giorgetti M, Holt N, Goehring L, Jette AM. Effect of a home-based exercise program on functional recovery following rehabilitation after hip fracture: a randomized clinical trial. JAMA. 2014 Feb 19;311(7):700-8. doi: 10.1001/jama.2014.469.

  PMID: 24549550 DERIVED

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Alan M Jette, PhD

  Health & Disability Research Institute

  PRINCIPAL INVESTIGATOR

• Nancy Latham, PhD

  Health & Disability Research Institute

  PRINCIPAL INVESTIGATOR

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: Director, Health and Disability Research Institute

Study Record Dates

• First Submitted: January 2, 2008
• First Posted: January 14, 2008
• Study Start: April 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 23, 2013

Record last verified: 2013-04

Locations

US (1)