Home-based Exercise Via a Telecommunications System
10. december 2013 opdateret af: US Department of Veterans Affairs
This study is investigating the effects of a home-based resistance exercise program, administered via an interactive telecommunications system, in functionally limited older veterans.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Inactivity and a sedentary lifestyle have been shown to accelerate and exaggerate the age-related decline in muscle strength.
In this context, a rapid decline in strength among older adults has been linked to physical frailty, falls, functional decline, impaired mobility, and nursing home placement.
Substantial evidence now suggests that habitual physical activity is associated with the maintenance of muscle strength and physical function well into the 8th and 9th decades of life.
We propose to investigate the effects of a home-based resistance exercise program, administered via an interactive telecommunications system without the participation of health professionals, in functionally limited older veterans.
Subjects will be randomized to either the automated exercise group or an attention placebo control group.
The exercise group will undergo resistance training at home three times a week for 6 months, guided by the telecommunications system, followed by a 6-month maintenance phase of less frequent interaction with the system.
Outcome measurements will include muscle strength and physical performance related to daily activities at 3, 6, and 12 months to determine the efficacy of the intervention and the time course and durability of the effect.
The control group will also interact with the telecommunications system once a week for the whole year, but no exercise will be prescribed.
If this home-based, automated, interactive exercise program is effective, it will provide a low-cost easily disseminated approach to improving the strength and functional status of older veterans
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
103
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02130
- VA Boston Health Care system
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
65 år og ældre (Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age 65 years
- Ability to use a telephone without assistance
Exclusion Criteria:
- Angina pectoris
- Myocardial infarction
- Ventricular dysrhythmia currently receiving therapy
- Systolic blood pressure 165 mm Hg or diastolic blood pressure 100 mm Hg
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Arm 1
exercise
|
|
|
Andet: Arm 2
health education
|
health education
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Knee Extension Strength
Tidsramme: 6 months
|
The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system
|
6 months
|
|
Knee Flexion Strength
Tidsramme: 6 months
|
The peak force measured during the bilateral knee flexion exercise against the highest level of a hydraulic resistance system
|
6 months
|
|
Single Leg Stance With Eyes Open
Tidsramme: 6 months
|
Length of time standing on one leg without moving the support foot, touching the floor or support leg with suspended foot, or requiring assistance.
|
6 months
|
|
Tandem Stance
Tidsramme: 6 months
|
Length of time standing with the heel of one foot touching the toe of the other foot keeping the feet in a straight line.
|
6 months
|
|
Six-minute Walk
Tidsramme: 6 months
|
Total distance walked during 6 minutes.
Subjects were instructed to walk up and down a 100-foot level hallway as far as they could in 6 minutes.
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Knee Extension Strength (Durability)
Tidsramme: 12 months
|
The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system
|
12 months
|
|
Knee Flexion Strength (Durability)
Tidsramme: 12 months
|
The peak force measured during the bilateral knee flexion exercise against the highest level of a hydraulic resistance system
|
12 months
|
|
Single Leg Stance With Eyes Open (Durability)
Tidsramme: 12 months
|
Length of time standing on one leg without moving the support foot, touching the floor or support leg with suspended foot, or requiring assistance.
|
12 months
|
|
Tandem Stance (Durability)
Tidsramme: 12 months
|
Length of time standing with the heel of one foot touching the toe of the other foot keeping the feet in a straight line.
|
12 months
|
|
Six-minute Walk (Durability)
Tidsramme: 12 months
|
Total distance walked during 6 minutes.
Subjects were instructed to walk up and down a 100-foot level hallway as far as they could in 6 minutes.
|
12 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: David William Sparrow, DSc, VA Boston Health Care system
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2003
Primær færdiggørelse (Faktiske)
1. april 2009
Studieafslutning (Faktiske)
1. november 2009
Datoer for studieregistrering
Først indsendt
2. november 2005
Først indsendt, der opfyldte QC-kriterier
3. november 2005
Først opslået (Skøn)
4. november 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
10. januar 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. december 2013
Sidst verificeret
1. december 2013
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- E2777-R
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