None listed
Conditions
Brief summary
Stroke survivors with poor balance and walking impairments have low activity levels and are at risk of falls. Targeted exercise can improve mobility. However, the absence of dose-finding studies may explain the limited effects of exercise delivered in many trials. In this dose-escalation study, we tested the feasibility of using dose-escalation methods, common in Phase 1 pharmaceutical trials, to determine the maximum tolerable dose of exercise in chronic stroke survivors with substantial mobility impairment.
Interventions
The study intervention was a 12 week multimodal exercise program, three sessions each week. Sessions were individual run by a rehabilitation physiotherapist at the participating hospital. The first 4 weeks were 360 min per week, next 4 weeks 420 min per week, last 4 weeks (dose Maximization) was guided by cumulative 3+3 dose escalation design aiming to go up to 750 min per week. A description and examples of the types of exercises are;
Endurance training was delivered using a combination of cyc
The study intervention was a 12 week multimodal exercise program, three sessions each week. Sessions were individual run by a rehabilitation physiotherapist at the participating hospital. The first 4 weeks were 360 min per week, next 4 weeks 420 min per week, last 4 weeks (dose Maximization) was guided by cumulative 3+3 dose escalation design aiming to go up to 750 min per week. A description and examples of the types of exercises are; Endurance training was delivered using a combination of cycling, treadmill and over-ground walking. Endurance training time was planned to progress by 5-15% every week. We aimed for a moderate level of training intensity, with the Borg Rate of Perceived Exertion (RPE) =11. Most endurance activities used steady state training, with interval training added for variety and when RPE levels dropped below 11. Planned interval training included a variety of regimes with a set time at a higher effort (on) followed by low effort recovery (off), e.g., 4 minutes on:2 minutes off, 3 minutes on:3 minutes off. Progressive Resistance Training (PRT) followed a standardized format. Five lower limb strengthening exercises, with free weights or pin-loaded machine weights, were tailored to each participant. Exercises included single or double leg press, calf press, hip abduction, hip extension, hamstring curls and quadriceps over fulcrum. Variation in the weight, number of sets, repetitions and speed of contractions were modified to vary the training stimulus. Amount of weight was increased if the target repetition maximum was achieved. During the Dose-maximization phase participants performed HVPRT, which involves rapid concentric, followed by slower eccentric, muscle contractions. Task-related practice was integral to the program, with emphasis on activities that challenged balance and community walking ability. Stepping and walking progressions included obstacle clearance of the lead and trail legs, variable surfaces, gradients, speed and direction changes, external perturbations, changing environmental demands and dual tasks.
Sponsors
Florey Institute of Neuroscience and Mental Health
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Aged at least 18 years with impaired balance, limited community walking and considered ‘at risk’ of falls. They must at discharge from our hospital also meet the following criteria: (1) walking less than 250 metres for the Six Minute Walk Test, (2) taking at least 15 seconds (or unable) to complete the Four Square Step Test, (3) cognitively able to follow an exercise program (equal to a score of 4 on the FIM19 problem solving, memory and comprehension items), (4) living at home, and (5) between 1 to 5 years post-stroke.
Exclusion criteria
To be eligible, written medical clearance to participate in an exercise program was required.
Outcome results
None listed