None listed
Conditions
Brief summary
Aim: To determine the minimum dose of exercise required to elicit a positive clinically meaningful improvement in cardiorespiratory fitness in stroke survivors. Eligible participants are independently- ambulant, community dwelling stroke survivors who have met the screening criteria. Fitness will be assessed pre, during and after an 8-week exercise intervention. Habitual activity (over a 7-day period) will also be assessed at these time points. Baseline measures include demographics (age, gender, living arrangements), stroke-specific variables (stroke type and severity, time since stroke, side affected, level of disability, anthropometric measures (height, weight, girths), cognitive function and exercise preference. Intervention Participants will participate an 8-week 3 day/week home-based individually prescribed exercise program and will be monitored remotely via tele-rehabilitation.. Exercise sessions will consist of 5 minute intervals at alternating higher/lower intensities (55-85% HR max), progressing from 30s/30s to 2min/2min by week 8 as tolerated. Programs will take into account initial fitness level, degree of disability and participant preference. The starting dose duration will be 30 min/week, progressing 15min/week per dose. The primary outcome will be the smallest dose of exercise required to increase cardiorespiratory fitness by 2ml.kg-1.min-1 in 8 weeks where dose is defined as the total number of minutes of exercise prescribed per week at a moderate to vigorous intensity (55 to 85% HR max). Secondary measures include blood pressure, weight, girths, cycle GXT peak power output, peak HR, lactate, walking ability, mood (anxiety and depression), physical activity level and health-related quality of life factors (HRQoL).
Interventions
Brief title: Home-based aerobic exercise program. 4 groups; Ex-Dose 1, Ex-Dose 2, Ex-Dose 3, Ex-Dose 4
The same intervention (home-based exercise aerobic exercise) will be delivered in all 4 arms of the trial, only the dose will differ.
Dose is defined as the total accumulated exercise time per week.
Ex-Dose 1 = 30 min/week (3 x 10min sessions)
Ex-Dose 2 = 45 min/week (3 x 15min sessions)
Ex-Dose 3 = 60 min/week (3 x 20min sessions)
Ex-Dose 4 = 75 min/week, (3 x 25min sessions)
Physical mat
Brief title: Home-based aerobic exercise program. 4 groups; Ex-Dose 1, Ex-Dose 2, Ex-Dose 3, Ex-Dose 4 The same intervention (home-based exercise aerobic exercise) will be delivered in all 4 arms of the trial, only the dose will differ. Dose is defined as the total accumulated exercise time per week. Ex-Dose 1 = 30 min/week (3 x 10min sessions) Ex-Dose 2 = 45 min/week (3 x 15min sessions) Ex-Dose 3 = 60 min/week (3 x 20min sessions) Ex-Dose 4 = 75 min/week, (3 x 25min sessions) Physical materials provided to participants: A heart rate monitor (includes a chest strap and wrist watch e.g. Garmin Forerunner 25, or similar) An iPad or Tablet (if they do not own a suitable device) An information booklet and exercise program The intervention consists of exercises designed to increase heart rate to required target zone. Exercises may include activities such as walking, marching, sit to stand exercises, mini-squats and combination exercises. Each exercise session will have a 5 minute warm up and cool down period. Exercise sessions will consist of short bouts of alternating high (target 85% HR max) and low (target 55% HR max) intensity activities. The length of the intensity bouts will progressively increase, to the target of 2 min low intensity/ 2 mins high intensity. Programs will take into account initial fitness level, degree of disability and participant exercise preference. The intervention will be delivered by research team members with minimum qualifications of bachelor degrees in exercise and sports science, physical education, physiotherapy, or other allied health, who have been trained by the lead investigator. All intervention sessions (home based aerobic exercise) will be supervised via the internet (telehealth) by research team members. Frequency: 3 times per week Time period: 8 weeks Number of sessions: 24 Intensity: Target intensity of 55-85% of age –predicted maximum heart rate Session Duration: The session duration will vary by group (Ex-Dose 1 = 10min/session; Ex-Dose 2 = 15min/session, Ex-Dose 3 = 20min/session, Ex-Dose 4 = 25min/session) plus 5 min warm up and 5 min cool down per session. Location: in-home The intervention will be personalised for each participant; based on their initial fitness, stroke severity, and exercise capacity such that the target heart rates are met in each session. Exercise programs may be adjusted individually if target intensities are not being met. Clinical judgement will be used to change or adapt programmed exercises if required while the overall dose is maintained. Intervention adherence: All exercise sessions will be supervised via telehealth, and heart rate data monitored in real time.
Sponsors
Univeristy of Newcastle
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Stroke at least 3 months prior Able to walk with no more than one person assist Medical clearance to exercise Internet access at home Suitable area to exercise at home and availability of responsible person at home to supervise exercise
Exclusion criteria
Unable to understand instructions in English due to language or cognitive impairments Pregnant or planning to be pregnant during study period Self-report current physical activity levels more than 20 minutes/day, 3 days/week Diagnosed acute or chronic illness with known physical activity contraindications or limits ability to to complete the fitness assessment or intervention Unable to commit to 10 consecutive weeks of study participation, including attending testing sessions Current enrolment in other research trial or rehabilitation therapy which focusses on encouraging participation in physical activity.
Outcome results
None listed