- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01740505
HealthySteps: Exercise for Older Adults With Mobility Limitation (HealthySteps)
19. januar 2015 opdateret af: Dawn C. Mackey, Simon Fraser University
HealthySteps: A Pilot Randomized Controlled Trial of Exercise to Improve Walking Energetics, Fatigue, and Activity in Older Adults With Mobility Limitation
This study will compare three different exercise programs in older adults who report difficulty walking and will determine if the programs improve walking.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
72
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 1M9
- Centre for Hip Health and Mobility, Vancouver Coastal Health Research Institute
-
-
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
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Men and women who live in the lower mainland (greater Vancouver) area of British Columbia
- Aged 65 years or older
- Living independently in their own home
- Report mobility limitation, defined as any difficulty walking one-quarter mile (about 2-3 blocks) outside on level ground or climbing one flight of stairs (about 10 steps) without resting because of a health or physical problem
Exclusion Criteria:
- Have a current medical condition for which exercise is contraindicated
- Have participated in an exercise intervention study in the past 6 months
- Do not have adequate cognitive function to provide informed consent and participate fully in the study
- Do not speak and understand English fluently
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Timing and Coordination
|
This intervention is based on progressively difficult stepping and walking patterns that promote the timing and coordination of stepping within the gait cycle.
Small-group 60-minute classes twice weekly for 12 weeks.
|
|
Eksperimentel: Aerobic Walking
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Outdoor walking with progressive increases in exercise intensity.
Small-group 60-minute classes twice weekly for 12 weeks.
|
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Aktiv komparator: Stretching and Relaxation
|
Full-body stretching, range-of-motion exercises, and relaxation techniques.
No specific gait training.
Small-group 60-minute classes twice weekly for 12 weeks.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
energy cost of walking
Tidsramme: 12 weeks
|
assessed by oxygen consumption during treadmill and overground walking
|
12 weeks
|
|
fatigue and fatigability
Tidsramme: 12 weeks
|
assessed by questionnaire, rated perceived exertion during walking, and decrements in walking performance over time.
|
12 weeks
|
|
daily activity
Tidsramme: 12 weeks
|
assessed by accelerometry and the Physical Activity Scale for the Elderly
|
12 weeks
|
|
life-space mobility
Tidsramme: 12 weeks
|
assessed by life-space mobility questionnaire
|
12 weeks
|
|
endurance
Tidsramme: 12 weeks
|
assessed by the long-distance corridor walk
|
12 weeks
|
|
physical function
Tidsramme: 12 weeks
|
assessed by standing balance, gait speed, and chair stands
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12 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
energy cost of walking
Tidsramme: 24 weeks
|
assessed by oxygen consumption during treadmill and overground walking
|
24 weeks
|
|
fatigue and fatigability
Tidsramme: 24 weeks
|
assessed by questionnaire, rated perceived exertion during walking, and decrements in walking performance over time
|
24 weeks
|
|
daily activity
Tidsramme: 24 weeks
|
assessed by accelerometry and the Physical Activity Scale for the Elderly
|
24 weeks
|
|
life-space mobility
Tidsramme: 24 weeks
|
assessed by the life-space mobility questionnaire
|
24 weeks
|
|
endurance
Tidsramme: 24 weeks
|
assessed by the long-distance corridor walk
|
24 weeks
|
|
physical function
Tidsramme: 24 weeks
|
assessed by standing balance, gait speed, and chair stands
|
24 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Dawn C Mackey, PhD, Simon Fraser University; Vancouver Coastal Health Research Institute, Centre for Hip Health and Mobility
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. januar 2013
Primær færdiggørelse (Faktiske)
1. november 2013
Studieafslutning (Faktiske)
1. november 2013
Datoer for studieregistrering
Først indsendt
23. november 2012
Først indsendt, der opfyldte QC-kriterier
29. november 2012
Først opslået (Skøn)
4. december 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
21. januar 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. januar 2015
Sidst verificeret
1. januar 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DFMG-001
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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