Back to resultsAcute Effects of Continuous Verses Interval Aerobic Training in Spinal Cord Injury Patient
Primary Purpose
Spinal Cord Injuries
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Interval Aerobic Exercise training Group
Continuous Aerobic Exercise training Group
Sponsored by
About this trial
This is an interventional supportive care trial for Spinal Cord Injuries focused on measuring Continuous Aerobic Exercise, Interval Aerobic Exercise
Eligibility 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
Sites / Locations
- Armed Forces Institute of Rehabilitation Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Interval Aerobic Exercise training Group
Continuous Aerobic Exercise training Group
Arm Description
Interval Aerobic Exercise for 4 weeks
Continuous aerobic exercise for 4 weeks
Outcomes
Primary Outcome Measures
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
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
Systolic and diastolic blood pressure
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
Secondary Outcome Measures
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
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
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.
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
Full Information
NCT ID
NCT05061160
First Posted
September 18, 2021
Last Updated
October 21, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05061160
Brief Title
Acute Effects of Continuous Verses Interval Aerobic Training in Spinal Cord Injury Patient
Official Title
Acute Effects of Continuous Verses Interval Aerobic Training on Autonomic Dysreflexia in Spinal Cord Injury Patient
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Continuous Aerobic Exercise, Interval Aerobic Exercise
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interval Aerobic Exercise training Group
Arm Type
Experimental
Arm Description
Interval Aerobic Exercise for 4 weeks
Arm Title
Continuous Aerobic Exercise training Group
Arm Type
Active Comparator
Arm Description
Continuous aerobic exercise for 4 weeks
Intervention Type
Other
Intervention Name(s)
Interval Aerobic Exercise training Group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Continuous Aerobic Exercise training Group
Intervention Description
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 Outcome Measure Information:
Title
Baroreflex sensitivity (BRS)
Description
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
Time Frame
4th Week
Title
Heart rate reserve (HRR)
Description
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
Time Frame
4th Week
Title
Systolic and diastolic blood pressure
Description
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
Time Frame
4th week
Secondary Outcome Measure Information:
Title
Oxygen saturation
Description
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
Time Frame
4th Week
Title
Pain perception
Description
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
Time Frame
4th week
Title
Exercise self-efficacy
Description
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.
Time Frame
4th week
Title
QOL Index-Spinal cord injury version questionnaire
Description
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
Time Frame
4th Week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Iqbal Tariq, MSCPPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Armed Forces Institute of Rehabilitation Sciences
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
44000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Acute Effects of Continuous Verses Interval Aerobic Training in Spinal Cord Injury Patient
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