| CTRI Number |
CTRI/2025/08/093169 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
15/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Studying How Arm Exercises Can improve Heart Health and Fitness in People with Paralysis of the Legs. |
|
Scientific Title of Study
|
Effect of Arm Cycle Ergometer Training on Heart Rate Variability and Physical Capacity in Paraplegics. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanshi Sharma |
| Designation |
MPT Student |
| Affiliation |
Indian Spinal Injuries Center- Institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, Sector C, Vasant Kunj,
New Delhi-110070
South West
DELHI
110070
India |
| Phone |
9953958443 |
| Fax |
|
| Email |
priyanshi0303@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shambhovi Mitra |
| Designation |
Associate Professor |
| Affiliation |
Indian Spinal Injuries Center- Institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, Sector C, Vasant Kunj,
New Delhi-110070
South West
DELHI
110070
India |
| Phone |
9711968166 |
| Fax |
|
| Email |
shams.physio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shambhovi Mitra |
| Designation |
Associate Professor |
| Affiliation |
Indian Spinal Injuries Center- Institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, Sector C, Vasant Kunj,
New Delhi-110070
South West
DELHI
110070
India |
| Phone |
9711968166 |
| Fax |
|
| Email |
shams.physio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Spinal Injuries Center- Institute of Rehabilitation Sciences Sector C, Vasant Kunj,
South West,
New Delhi ,
Delhi-110070,
India
|
|
|
Primary Sponsor
|
| Name |
Priyanshi Sharma |
| Address |
Indian Spinal Injuries Center- Institute of Rehabilitation Sciences Sector C, Vasant Kunj,
New Delhi,
South West,
Delhi-110070,
India
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shambhovi Mitra |
Indian Spinal Injuries Center-Institute of Rehabilitation Sciences |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences Sector C, Vasant Kunj,
South West,
Delhi-110070,
India
New Delhi
DELHI |
09711968166
shams.physio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: G959||Disease of spinal cord, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aerobic training for T1-T6 level of injury |
Arm Cycle Ergometer Training will be done .
Training will be given for 5 days per week for 4 weeks.
Session consists of:
5 minute warm up through upper limb stretching.
Training through Arm Cycle Ergometer(ACE).
Progression in training will be made with either increase in time or with increase in intensity.
Duration:
Week 1 : for 10 minutes per day,
Week 2 : for 15 minutes per day,
Week 3 : for 15 minutes per day,
Week 4 : for 20 minutes per day.
Intensity: On the basis of:
CR 10 (mild) for week 1 and week 2 and
CR 10 (moderate) for week 3 and week 4 .
In the end
5 minutes cool down through Resistance free ACE. |
| Comparator Agent |
Aerobic training for T7-T12 level of injury |
Arm Cycle ergometer training will be done.
Participants with SCI below T6, where autonomic function and HRV are generally preserved, that is why this will serve as the comparator group and will receive the same Arm Cycle Ergometer Training protocol as the intervention group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Level of injury: T1 – T12 (AIS-A, B, C)
Individual who use a wheel chair for more than 75% of the time they are awake. |
|
| ExclusionCriteria |
| Details |
Person with neurological deficits (other than SCI)and pre-diagnosed psychiatric illness.
Clinically diagnosed of unstable angina or MI within post 1 month.
Resting HR more than 120 bpm
Systolic BP more than 180 mmHg and Diastolic BP more than 100 mmHg.
Participants on medication that affects the regulation of heart rate (such as b-blockers, etc.)
Individual diagnosed with medical issues such as pressure sores, urinary tract infections, cardiac disorders, or musculoskeletal complain of upper extremities will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Heart rate Variability
[SDNN] |
Baseline and at the end of training |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
6 minute push test
|
Baseline and at the end of training |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Spinal cord injury (SCI) causes motor, sensory, and autonomic dysfunction, with higher-level injuries (above T6) leading to greater autonomic dysfunction which depends on injury level due to imbalance in parasympathetic and sympathetic nervous system. Heart rate variability (HRV) which is a key marker for assessment of autonomic function is often reduced in SCI . Physical activity may improve HRV in SCI. This study aims to investigate the effects of an 4 week arm cycle ergometer (ACE) training program on autonomic function and physical capacity in individuals with thoracic spinal cord injury (SCI). Thirty participants will be stratified into two groups based on level of injury (T1–T6 and T7–T12). Primary outcome will be heart rate variability (HRV), and secondary outcome will be the 6-minute push test (6MPT). Assessments will be conducted at baseline and post-intervention. The study will analyze whether level of injury influences the response to ACE training, with the goal of improving cardiovascular health and functional performance in the SCI population. Intervention Summary:
Participants will undergo an arm cycle ergometer (ACE) aerobic exercise program, 5 days/week for 4 weeks. The program is designed with gradual progression in both duration and intensity. Each session will follow a structured format for both the groups. Warm-up: 5 minutes ( upper extremity stretching ) Main exercise: ACE training , with duration increasing weekly: Week 1: 10 minutes per day Week 2: 15 minutes per day Week 3: 15 minutes per day Week 4: 20 minutes per day Cool-down: 5 minutes (resistance-free ACE) Intensity: Borg CR-10 scale mild in Weeks 1 to 2 and moderate in Weeks 3 to 4.
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