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Efficacy of a Post-Rehabilitation Exercise Intervention

22 april 2013 uppdaterad av: Alan Jette, Boston University

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:

  1. 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.
  2. The SFL program will significantly improve health-related quality of life among participants at 6-month follow-up.
  3. 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.

Target population:

The target population will be people aged 60 years or more who have suffered a recent traumatic hip fracture, have one or more residual functional limitations and have completed all inpatient, outpatient or homecare rehabilitation services.

Intervention:

We will use an enhanced version of the Strong for Life program. This home-based exercise program will include both resistance exercises using Thera-bands that will be shown on a video/DVD and weight-bearing exercises that are progressed using a step and/or a weighted vest. A cognitive-behavioral program that is customized for people recovering from hip fracture is being developed that will focus on promoting exercise adherence, decreasing fear of falling and increasing the return to daily activities in the patient's home and community.

Design:

A randomized controlled clinical trial will be implemented to measure the efficacy of the Strong for Life program. An attention-control intervention will be provided to all participants assigned to the control group. The outcome evaluation points are:

  • 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.

Studieöversikt

Studietyp

Interventionell

Inskrivning (Faktisk)

232

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Massachusetts
      • Cambridge, Massachusetts, Förenta staterna, 02138
        • Spaulding Rehabilitation Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

60 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 1

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.

Placebo-jämförare: cardiovascular education (attention control)
administered as an attention control intervention using home visits, phone calls and mail-outs of information

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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.
Tidsram: baseline, 6-month and 9-month follow up
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

Sekundära resultatmått

Resultatmått
Tidsram
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.
Tidsram: baseline, 6-month and 9-month follow up
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.
Tidsram: baseline, 6-month and 9-month follow up
baseline, 6-month and 9-month follow up

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Alan M Jette, PhD, Health & Disability Research Institute
  • Huvudutredare: Nancy Latham, PhD, Health & Disability Research Institute

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2008

Primärt slutförande (Faktisk)

1 september 2012

Avslutad studie (Faktisk)

1 november 2012

Studieregistreringsdatum

Först inskickad

2 januari 2008

Först inskickad som uppfyllde QC-kriterierna

11 januari 2008

Första postat (Uppskatta)

14 januari 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

23 april 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 april 2013

Senast verifierad

1 april 2013

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • NINR 1R01NR010815-01A2
  • 1R01NR010815-01A2 (U.S.S. NIH-anslag/kontrakt)

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Kliniska prövningar på Höftfraktur

Kliniska prövningar på Enhanced Strong for Life

3
Prenumerera