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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05061160
Recruitment Status : Completed
First Posted : September 29, 2021
Last Update Posted : October 24, 2022
Sponsor:
Information provided by (Responsible Party):
Riphah International University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: Interval Aerobic Exercise training Group Other: Continuous Aerobic Exercise training Group Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Acute Effects of Continuous Verses Interval Aerobic Training on Autonomic Dysreflexia in Spinal Cord Injury Patient
Actual Study Start Date : October 15, 2021
Actual Primary Completion Date : August 30, 2022
Actual Study Completion Date : August 30, 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Interval Aerobic Exercise training Group
Interval Aerobic Exercise for 4 weeks
 Other: Interval Aerobic Exercise training Group

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.
Active Comparator: Continuous Aerobic Exercise training Group
Continuous aerobic exercise for 4 weeks
 Other: Continuous Aerobic Exercise training Group

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.


Outcome Measures
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Primary Outcome Measures :
  1. Baroreflex sensitivity (BRS) [ Time Frame: 4th Week ]
    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

  2. Heart rate reserve (HRR) [ Time Frame: 4th Week ]
    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

  3. Systolic and diastolic blood pressure [ Time Frame: 4th week ]
    Changes from the Baseline, Blood pressure is measured through sphygmomanometer


Secondary Outcome Measures :
  1. Oxygen saturation [ Time Frame: 4th Week ]
    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

  2. Pain perception [ Time Frame: 4th week ]
    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

  3. Exercise self-efficacy [ Time Frame: 4th week ]
    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.

  4. QOL Index-Spinal cord injury version questionnaire [ Time Frame: 4th Week ]
    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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05061160


Locations
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Pakistan
Armed Forces Institute of Rehabilitation Sciences
Rawalpindi, Punjab, Pakistan, 44000
Sponsors and Collaborators
Riphah International University
Investigators
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Principal Investigator: Muhammad Iqbal Tariq, MSCPPT Riphah International University
More Information
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Responsible Party: Riphah International University
ClinicalTrials.gov Identifier: NCT05061160    
Other Study ID Numbers: REC/01080 Maryam Tahir
First Posted: September 29, 2021    Key Record Dates
Last Update Posted: October 24, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riphah International University:
Continuous Aerobic Exercise
Interval Aerobic Exercise
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System