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

• Sponsor: Riphah International University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05061160
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8.5
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Oct 15, 2021
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

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

Primary Outcome Measures

1. Baroreflex sensitivity (BRS) [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) [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 [4th week]

   Changes from the Baseline, Blood pressure is measured through sphygmomanometer

Secondary Outcome Measures

1. Oxygen saturation [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 [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 [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 [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

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Armed Forces Institute of Rehabilitation Sciences	Rawalpindi	Punjab	Pakistan	44000

Sponsors and Collaborators

• Riphah International University

Investigators

• Principal Investigator: Muhammad Iqbal Tariq, MSCPPT, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Riphah International University
• ClinicalTrials.gov Identifier: NCT05061160
• Other Study ID Numbers: REC/01080 Maryam Tahir
• First Posted: Sep 29, 2021
• Last Update Posted: Jun 1, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Spinal Cord Injuries; Wounds and Injuries

Study Results

No Results Posted as of Jun 1, 2022