None listed
Conditions
Brief summary
This project is a pilot randomised controlled trial. The main aim is to test whether it is possible to recruit and follow trial procedures in addition to working out how much benefit may come from the treatment in order to make sure enough participants are recruited for a future large randomised controlled trial. The main hypothesis is that adding cardiovascular (or fitness) training to normal rehabilitation in people who have had a stroke will be possible to do and safe for the patient. The next aim is to test the effect of the fitness training on cardiovascular fitness, walking speed and endurance; quality of life (QOL) and depression. The objective of the future randomised controlled trial will be to determine whether the moderate-intensity CV training program significantly improves the defined outcomes compared to ‘usual’ rehabilitation care. The trial will be run in an outpatient rehabilitation service of a tertiary public hospital in metropolitan Melbourne. People will be eligible to be in the trial if they have been diagnosed with a stroke more than six weeks prior; are over 18 years old; able to walk by themselves with or without a gait aid or supervision of another person; and do not have medical or other limitations to exercise. Participants currently taking medications that may affect heart rate response to exercise will be included in the trial. 20 people will be selected to receive either the treatment or normal care. People measuring outcomes won't know which group the patient is in. All participants will be tested for fitness (VO2 peak); walking speed; and quality of life and depression. The treatment group will receive two supervised sessions of moderate-intensity fitness training each week for twelve weeks. Exercise will commence at 10 minutes, and progress incrementally, as tolerated, to 30 mintues duration, prior to progression of exercise intensity. Progression of duration and intensity will be determined by trained physiotherapists, using the Karvonen method (ACSM 2010). People will either exercise with a recumbent or standard stationary bike, treadmill, stepper or cross-trainer. Participants currently taking heart rate control medications will utilise a scale of how hard they are working to monitor exercise intensity. A home exercise program of CV training will be prescribed, and gradually increased in frequency. People should progress to doing a total of 150 minutes of CV exercise in weeks 9-12 of the trial, as recommended by the NHF guidelines for aerobic exercise (Briffa et al 2006). People assigned to the usual rehab group will receive two sessions per week of a light strengthening and balance exercise program. These participants will have heart rate monitoring at five-minute intervals to maintain low-intensity exercise. Session length will be progressed from 10 minutes for 4 weeks, to 20 minutes for 4 weeks, and 30 minutes for final 4 weeks. A general home exercise program will also be given to this group.
Interventions
Moderate-intensity cardiovascular fitness training prescribed and supervised by a physiotherapist in the outpatient rehabilitation setting.
Frequency: 2 sessions each week; commence 5 minutes duration, progress by 2-5 minutes each session as client tolerates to a maximum of 30 minutes duration per session. Duration: 12 weeks.
Mode: Stationary bike; treadmill or overground walking; cross trainer; stepper, as deemed appropriate by physiotherapist. Intensity: Moderate intensity training will be c
Moderate-intensity cardiovascular fitness training prescribed and supervised by a physiotherapist in the outpatient rehabilitation setting. Frequency: 2 sessions each week; commence 5 minutes duration, progress by 2-5 minutes each session as client tolerates to a maximum of 30 minutes duration per session. Duration: 12 weeks. Mode: Stationary bike; treadmill or overground walking; cross trainer; stepper, as deemed appropriate by physiotherapist. Intensity: Moderate intensity training will be calculated using the heart rate reserve method, or Karvonen method, where moderate-intensity is 40-59% maximum (ACSM., 2010). Target heart rate will be calculated each session. BORG-RPE and heart rate will be used to monitor moderate-intensity exercise. Participation in home exercise program will occur concurrently with supervised sessions (ie. during same 12 week period). Participants should commence the home exercise program once deemed safe to participate in a particular mode, generally overground walking, and self-monitor their own work levels using heart rate monitoring or the BORG-RPE scale. Frequency: Weeks 1-4: 1 session; Weeks 5-8: 2 sessions; Weeks 9-12: 3 sessions, at duration consistent with supervised sessions. Participants will be provided with a weekly home exercise record with clear recommendations of mode/duration/intensity, and check boxes to record exercise completion; BORG-RPE or heart rate.
Sponsors
Johanna Reynolds
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Aged 18 years or older; diagnosed with an ischaemic or haemorrhagic stroke at least six weeks; and no more than 12 months, prior to recruitment; admitted to outpatient centre-based CBR physiotherapy at Western Health; able to walk at least 100m, with or without a gait aid or supervision from another person.
Exclusion criteria
Unable to physically participate in CV exercise at low to moderate intensity; documented medical restrictions to CV training in CBR referral; unable to follow two-stage commands or indicate symptoms during exercise; pregnant; the following comorbidities documented in their referral/medical history or GP screen: cardiovascular instability, including unstable angina, acute or complex arrhythmia; severe aortic valve disease or stenosis; severe left ventricular dysfunction; history of unstable cardiac failure or uncontrolled hypertension; pulmonary hypertension; interstitial lung disease; severe renal impairment; acute infection or fever (local or systemic); uncontrolled diabetes; recent myocardial infarction requiring acute intervention (< 6/52 prior to recruitment); acute myocarditis or pericarditis; acute pulmonary embolism or infarction; neurosurgery less than 6/52 prior to recruitment date.
Outcome results
None listed