High Intensity Interval Training in Chronic Stroke Patients

Recruiting

Phase N/A Results N/A

Trial Description

Stroke is a global health-care problem that is common, serious and disabling. In most countries, stroke is second or third most common cause of death and one of the main causes of acquired adult disability. After stroke, patients remain at continued high risk for recurrent stroke as well as for myocardial infarction and cardiac death. After completion of conventional physical therapy, there are no empiric recommendations and few resources promoting regular exercise during the chronic stroke period.Interventions to improve cardiorespiratory fitness are still not part of routine neurorehabilitation programs in many rehabilitation centers, and therapy is often dominated by standard rehabilitative therapies based on neurodevelopmental principles such as the Bobath concept. These standard therapies are an insufficient stimulus to increase fitness levels after stroke.

Detailed Description

Stroke is a major cause of chronic disability worldwide. After stroke, patients remain at continued high risk for recurrent stroke as well as for myocardial infarction and cardiac death. Comorbid cardiovascular conditions are present in 75% of stroke patients, representing the leading cause of death in stroke survivors. Due to the low levels of physical activity, stroke survivors are deconditioned, leading to a loss of functional and social independence with subsequent declines in quality of life. Interventions to improve cardiorespiratory fitness are still not part of routine neurorehabilitation programs in many rehabilitation centers, and therapy is often dominated by standard rehabilitative therapies based on neurodevelopmental principles such as the Bobath concept. These standard therapies are an insufficient stimulus to increase fitness levels after stroke.
The first aim of the study is to evaluate the effects of a high intensitive physical training in improving cardiorespiratory fitness and gait ability in chronic stroke patients. The second aim is to compare the effects of high aerobic interval treadmill training and maximal strength training in chronic stroke patients.
Patients will be randomized into three groups. The first group (experimental group) will be subjected to 3-month training period (3 sessions/week) of high intensity aerobic training on treadmill. The second group (experimental group group) will undergo to a strength training with the same duration and frequency of the first group. The third group (control group)will be subjected to conventional training with the same duration and frequency of the experimental groups. Data will be analysed by means parametric and non-parametric tests. Both, within and between groups comparison will be performed.
As primary outcomes measures will be considered the peak oxygen uptake, walking energy cost, 6 minutes walking test. As secondary outcomes measures will be considered the 10-meter Walking Test,Time Up and Go test, Activities- specific balance confidence scale, SF-36 Health Survey Questionnaire, Stroke Impact Scale, Oxygen Uptake Efficiency Slope (OUES), arterial-venous oxygen difference; cardiac output and muscle strength.

Conditions

Interventions

  • High intensity aerobic training Other
    Intervention Desc: The mode of the training will be uphill treadmill walking in 4x4 minute intervals at 85% and 95% of Heart Rate Peak (HRpeak) precede by 10-minute warm-up period on the treadmill at self-selected speed and inclination. Between the 4-minute intervals, 3-minute active breaks walking at approximately 50% of HRpeak will be applied. The training sessions will be terminated by a 3-minute cool-down period at 50% to 70% HRpeak. To compensate for increased VO2peak, the speed and/or inclination will be gradually adjusted during 3-month intervention to make sure that the target HR will be between 85% and 95% of HRpeak during the high-intensity intervals.
    ARM 1: Kind: Experimental
    Label: High Intensity Aerobic training
    Description: The subjects will perform a high intensity treadmill training
  • High Intensity Strength Training Other
    Intervention Desc: Five warm-up repetitions will be completed at approximately 50% of 1 repetition maximum before the main session of four sets of four repetitions unilaterally at 85%Y95% of 1 repetition maximum for both leg press and plantarflexion. When subjects will be able to complete a fifth repetition, the weight will be increased by 1.25 to 2.5 kg, dependent on subjective feelings of capability. They will be encouraged to focus of an explosive concentric movement and a controlled eccentric movement such that the time on each phase will be in the ratio 1:2. The subjects will be regularly reminded to focus on breathing during the contraction, preventing the valsalva maneuver and high rises in blood pressure. The session will finish with a minimum 5-min warm down the treadmill device.
    ARM 1: Kind: Experimental
    Label: High Intensity Strength Training
    Description: The subjects will perform and high intensity training on the same leg horizontal press.
  • Mixed Training Other
    Other Names: Conventional Training
    Intervention Desc: Conventional training consisted of group mobility, balance and stretching exercises. Mobility training included treadmill and cycloergometer training for 10 minutes at self selected speed. Exercises at the parallel bars included weight shift from leg to leg, half-squat, turn in place, leg-trunk flexion, and extension exercises. Finally seated upper- and lower-limb stretching exercises will focus on range of motion, including trunk mobility.
    ARM 1: Kind: Experimental
    Label: Mixed Training
    Description: Conventional training consisted of group mobility, balance and stretching exercises.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 6 minutes walking test (6-MWT) All patients enrolled in the study will be evaluated at baseline time 0 of treatment and after after 12 weeks of training. Yes
Secondary 10 meters Walking test (10-MtWT) Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training Yes
Secondary Time Up and Go Test (TUG) Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training Yes
Secondary Gait analysis Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training Yes
Secondary Strength Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training Yes
Secondary Arterial - venous oxygen difference (a-v O2 diff) Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training Yes
Secondary Cardiac Output (CO) Basline, Post- training, Follow- up 6 and 9 months Yes
Secondary Oxygen Uptake Efficiency Slope (OUES) Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training Yes
Secondary Activities- specific Balance Confidence Scale: Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training Yes
Secondary SF-36 Health Survey Questionnaire Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training Yes
Secondary Stroke Impact scale Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training Yes
Secondary Peak of Oxygen Consumption (VO2peak) Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training Yes
Secondary Walking energy cost (Wc) Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training Yes

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