Acute Effects of Continuous Verses Interval Aerobic Training in Spinal Cord Injury Patient

Study Overview
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Brief Summary
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To determine the Acute effects of continuous verses interval aerobic training on autonomic dysreflexia in Spinal Cord injury Patient. To Determine the Acute effects of these training on, Exercise Self efficacy and pain.

Official Title
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Acute Effects of Continuous Verses Interval Aerobic Training on Autonomic Dysreflexia in Spinal Cord Injury Patient

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Other: Interval Aerobic Exercise training Group
* Other: Continuous Aerobic Exercise training Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Spinal cord injury Patients with level of injury below T 10 Acute Spinal Cord Injury (Usually Acute phase lasts 8-12 weeks) Patients Had experience of Syncope or Postural Hypotension Exclusion Criteria: Neurological disease, Cognitive impairment (Mini-Mental State Examination < 22) , Acute and chronic infections

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interval Aerobic Exercise training Group<br>Interval Aerobic Exercise for 4 weeks | Other: Interval Aerobic Exercise training Group<br>* Interval Aerobic exercise will be on upper limb Bicycle with a pause of 3 mins interval Interval Aerobic Exercises: Frequency= 3 times per week Intensity= 50% of heart rate reserve for 2 mins 80% of heart rate reserve for 1 min Type= interval aerobic exercise Time= 40 minutes There will be 5 minutes for warm up and 5 minutes for cool down.<br>|
| Active Comparator: Continuous Aerobic Exercise training Group<br>Continuous aerobic exercise for 4 weeks | Other: Continuous Aerobic Exercise training Group<br>* Continuous Aerobic exercise will be on upper limb Bicycle Continuous Aerobic Exercise: Frequency= 3 times per week Intensity= 50% of heart rate reserve Type= continuous aerobic exercise Time= 40 minutes There will be 5 minutes for warm up and 5 minutes for cool down.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baroreflex sensitivity (BRS) | BRS is the index which is used to quantify the control of baroreflex on the heart rate. Patient's beat to beat arterial pressure and heart rate are measured simultaneously with the Maximal expiratory pressure (MEP) manoeuvre or valsalva manoeuvre. Changes from the baseline to 4 week will be analyzed | 4th Week | 
| Heart rate reserve (HRR) | It is the difference between resting heart rate and maximum heart rate. HRR is primarily use to determine heart rate zone for exercise. HRR can be calculated by subtracting resting heart rate from maximum heart rate. Changes from the baseline to 4 week will be analyzed | 4th Week | 
| Systolic and diastolic blood pressure | Changes from the Baseline, Blood pressure is measured through sphygmomanometer | 4th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen saturation | Amount of oxygen in the blood is known as oxygen saturation. normal range is 94-99 percent. Pulse oximeter is used to measure oxygen saturation. Changes from the baseline to 4 weeks | 4th Week | 
| Pain perception | Pain is defined as unpleasant sensation which is generated by body as a protective response to prevent further tissue damage. It will be measured with the help of Numeric pain rating scale ranging 0 to 10. where 0 is no pain and 10 is the worst pain imaginable. Changes from the baseline to 4 week will be analyzed | 4th week | 
| Exercise self-efficacy | It is defined as how much an individual consider he eligible to perform the given exercise. Spinal Cord Injury (SCI) Exercise Self Efficacy scale will be provided to the individuals at the baseline and then after 72 hours i.e 3 days of training/week. It has total of 10 questions which allow the participants to indicate on four point scale how much confident they are about the exercise. | 4th week | 
| QOL Index-Spinal cord injury version questionnaire | QOL index spinal cord injury version is used to assess the quality of life of spinal cord injury patients. It has 32 to 37 items. Each item is rated on scale of 1 to 6.5 scores of 0-30 are calculated.1) quality of life, 2) health and functioning, 3) social and economic life, 4) physiological life, and 5) family life. Changes from the baseline to 4th week will be analyzed | 4th Week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous Aerobic Exercise, Interval Aerobic Exercise