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Completed

NCT Number: NCT05061160

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

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.

Completed

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Armed Forces Institute of Rehabilitation Sciences

Rawalpindi, Punjab Province, 44000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interval Aerobic Exercise training Group

Other

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.

Continuous Aerobic Exercise training Group

Other

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 29, 2021
Registry last updated
Oct 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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