NCT05061160

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 29, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

October 15, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

October 24, 2022

Status Verified

October 1, 2022

Enrollment Period

11 months

First QC Date

September 18, 2021

Last Update Submit

October 21, 2022

Conditions

Keywords

Continuous Aerobic ExerciseInterval Aerobic Exercise

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Systolic and diastolic blood pressure

    Changes from the Baseline, Blood pressure is measured through sphygmomanometer

    4th week

Secondary Outcomes (4)

  • Oxygen saturation

    4th Week

  • Pain perception

    4th week

  • Exercise self-efficacy

    4th week

  • QOL Index-Spinal cord injury version questionnaire

    4th Week

Study Arms (2)

Interval Aerobic Exercise training Group

EXPERIMENTAL

Interval Aerobic Exercise for 4 weeks

Other: Interval Aerobic Exercise training Group

Continuous Aerobic Exercise training Group

ACTIVE COMPARATOR

Continuous aerobic exercise for 4 weeks

Other: Continuous Aerobic Exercise training Group

Interventions

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.

Interval 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.

Continuous Aerobic Exercise training Group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Neurological disease,
  • Cognitive impairment (Mini-Mental State Examination \< 22) ,
  • Acute and chronic infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Armed Forces Institute of Rehabilitation Sciences

Rawalpindi, Punjab Province, 44000, Pakistan

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Muhammad Iqbal Tariq, MSCPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2021

First Posted

September 29, 2021

Study Start

October 15, 2021

Primary Completion

August 30, 2022

Study Completion

August 30, 2022

Last Updated

October 24, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations