None listed
Conditions
Brief summary
This is a novel dose-escalation study to find the maximum tolerable cardiorespiratory fitness (CRF) training intensity in acute stroke survivors. Small consecutive groups of five stroke survivors receive a CRF training program at a certain intensity. In the next cohort of five participants, the intensity can escalate, stay the same or the study will be stopped and will be based on pre-defined rules. The rules are determined by the occurrence of symptoms of over-exercising in each cohort i.e. increase in pain and exhaustion. If the study is stopped the intensity in the previous cohort of 5 will be regarded as the maximum tolerable training intensity.
Interventions
Physical Fitness Training The intervention will consist of two components: cardiorespiratory fitness (CRF) training and strength training. The CRF training configuration will be interval training with active rest. The CRF training exercise-rest ratios 1:1 min. CRF training The duration of the CRF training component will be 30 minutes (excluding warm-up and cool down). Each session will start with a low intensity warm up and finish with a cool down each lasting about 5 minutes. The mode of CRF training will be interval training with active rest-periods where possible. The exercise modality can be treadmill walking, cycling on an ergometer, overground walking, rowing or exercise on the recumbent stepper and will decided according to the availability of exercise machines and participant’s preference. Participants will attend 3 CRF training sessions per week for a total period of 4 weeks. During the first two weeks, each participant will start with an adaptation period (Phase I) after testing and assessments. In this phase participants will be familiarized with the training procedures and exercises. During Phase I the training intensity which is determined by the percentage of heart rate reserve, will be increased for each bout of exercise within the session or between sessions, based on the individual performance, until the target intensity is reached. This target intensity is predefined and is the same for all participants in the same cohort. The dose will escalate according to a dose-escalation schedule for each following cohort that will be included in the study. The dose intensity will increase with increments of 5% of heart rate reserve. The safety and tolerability of the target intensity will be tested in the last two weeks i.e. Phase II. Strength training In addition to the CRF training component participants will also get functional strength training with a frequency of 2 times per week, which will be added on to the first and the last session of the CRF training of the week. Participants will perform three whole body strength exercises. The intensity is based on the pre-training strength tests. The same three exercises will be performed by the same participant for the duration of their involvement in the study. The intensity of strength training will be increased to a max of 4 sets of 12 repetitions. The dose will first increase by adding repetitions to a max of 12 per set. If 12 repetitions are reached than another set will be added and repetitions per set will be set back to 8 per set. If the maximum number of sets and repetitions are reached the resistance will be increased where possible. There are no specific target doses set for the participants in any of the cohorts. The screening and baseline assessments will be performed at the exercise clinic at the a research institute on the acute hospital campus. The exercise program will take place at different locations depending on the current location of the participants and include the acute hospital, inpatient or outpatient rehabilitation centres or at the research institute. The exercise intervention will be administered by a trained researcher.
Sponsors
Study design
Eligibility
Inclusion criteria
1) ischaemic stroke diagnosis based on MRI/CT or clinical diagnosis, 2) are within 3 weeks post stroke, 3) have no pre-morbid or current restrictions to exercise, 4) are able to transfer from a sitting position to a standing position either independently or with physical assistance, 5) are able to provide informed consent to participate in the study
Exclusion criteria
1) hospitalization for myocardial infarction, heart surgery, or congestive heart failure during the preceding 3 months; 2) significant cardiac pathology (arrhythmia, hypertrophic cardiomyopathy, severe aortic stenosis, or pulmonary embolus); 3) significant pulmonary pathology (i.e. severe chronic obstructive pulmonary disease) and 4) musculoskeletal or neurological problems from conditions other than stroke that would limit the ability to exercise (e.g. Parkinson’s Disease, severe osteoarthritis).