Understanding Changes in Heart Function After Exercise in People With Stroke
Beyond VO2peak: Understanding Exercise-induced Changes in Cardiovascular Function After Stroke
Little is known about how exercise can affect heart function in stroke survivors.
This study will look at changes in cardiovascular fitness and function after 6 months of exercise. Volunteers will be tested before and after the program and again 2 months later to measure the effects on stroke risk factors, fitness level and flexibility of the arteries. Blood tests will measure cholesterol levels and other signs of inflammation.
This study will help us better understand how exercise after stroke can improve heart function and heart health, and ultimately help in lowering future stroke risk.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Purpose
To determine the effects of aerobic exercise after stroke on cardiorespiratory fitness, cardiovascular function, stroke risk factors, walking and health-related quality of life. This study will also examine the retention of these effects after the exercise program ends.
Methods
A randomized controlled study design will be used. Sixty participants will be randomized to participate in one of 2 treatment arms (6 months duration, 3 days / week, 1 hour / session):
- BALANCE AND FLEXIBILITY (non-aerobic) PROGRAM will be comprised of individualized upper and lower body stretching, or balance activities, yoga- or Tai Chi-style classes.
- AEROBIC PROGRAM will be comprised of a structured, progressive aerobic training program.
Participants will be evaluated at 3 time points - baseline (0 months), post-intervention (6 months) and follow up (8 months) - for stroke risk factors, cardiorespiratory fitness, arterial stiffness, echocardiography measures, inflammatory biomarkers, ambulatory capacity and health-related quality of life.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
British Columbia
-
Vancouver, British Columbia, Canada
- Vancouver General Hospital
-
Vancouver, British Columbia, Canada
- GF Strong Rehabilitation Centre
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age 50-80 years old
- Has experienced a stroke
- At least 12 months post-stroke
- Able to stand independently
- Able to walk at least 5 metres (assisted devices and guarded supervision is permitted)
Exclusion Criteria:
- Stroke of non-cardiogenic origin (aneurysm, tumour)
- Actively engaged in other stroke rehabilitation services
- Class C or D American Heart Association Risk Criteria (uncontrolled arrhythmias)
- Resting blood pressure > 160/100 mmHg
- Significant musculoskeletal problems (rheumatoid arthritis) or other neurological conditions (e.g. Parkinson's)
- Has a pacemaker
- Pain or other co-morbidities (e.g. unclipped aneurysms, uncontrolled seizures etc.) which would preclude participation
- Behavioural issues that would limit participation in exercise
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Aerobic Program
The Aerobic Program will be the Experimental arm of this trial, where a structured, progressive aerobic exercise will be conducted in a class format
|
The AEROBIC PROGRAM will be the Experimental arm of this trial.
It will be a structured, progressive aerobic training program that will be 6 months in duration.
Classes will be held 3 times / week, for 1 hour / session.
|
|
Aktiv komparator: Balance and Flexibility Program
The Balance and Flexibility Program will be a non-aerobic intervention that will act as an Active Comparator.
Stretching, balance exercises, yoga- or Tai Chi-style classes will be conducted.
|
The BALANCE AND FLEXIBILITY (non-aerobic) PROGRAM will be the Active Comparator arm of this trial.
It will be comprised of upper and lower body stretching, or balance activities, yoga- or Tai Chi-style classes.
This program will be 6 months in duration.
Classes will be held 3 times / week, for 1 hour / session.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Stroke risk factors (blood pressure, heart rate, lipid profiles, glucose metabolism), cardiorespiratory fitness
Tidsramme: assessed at baseline (0 months), post-program (6 months) and follow up (8 months)
|
assessed at baseline (0 months), post-program (6 months) and follow up (8 months)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Arterial stiffness and inflammatory biomarkers
Tidsramme: assessed at 0, 6 and 8 months
|
assessed at 0, 6 and 8 months
|
|
Echocardiography measures
Tidsramme: assessed at 0 and 6 months
|
assessed at 0 and 6 months
|
|
Ambulatory capacity and health related quality of life
Tidsramme: assessed at 0, 6 and 8 months
|
assessed at 0, 6 and 8 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Janice Eng, PhD, The University of British Columbia - Vancouver Coastal Health Research Institute
- Studieleder: Penelope Brasher, PhD, Vancover General Hospital
- Studieleder: Andrei Krassioukov, MD, PhD, University of British Columbia
- Studieleder: Kenneth Madden, MD, University of British Columbia
- Studieleder: Ada Tang, University of British Columbia
- Studieleder: Teresa Tsang, MD, University of British Columbia
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- H10-00735
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