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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05061160
• Other study ID #: REC/01080 Maryam Tahir
• Status: Completed
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: October 2022
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Pakistan	Armed Forces Institute of Rehabilitation Sciences	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Systolic and diastolic blood pressure	Changes from the Baseline, Blood pressure is measured through sphygmomanometer	4th week
Secondary	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
Secondary	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
Secondary	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
Secondary	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