| CTRI Number |
CTRI/2024/04/065180 [Registered on: 04/04/2024] Trial Registered Prospectively |
| Last Modified On: |
27/03/2024 |
| 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
|
To check effect of aerobic capacity and muscle strength using circuit training in spinal cord injury patients |
|
Scientific Title of Study
|
Impact of Circuit Training on Aerobic Capacity and Muscle Strength in Individuals with Spinal Cord Injury |
| Trial Acronym |
No |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shubham Vinay Gajare |
| Designation |
PG student |
| Affiliation |
Pravara Institite of Medical Sciences Loni |
| Address |
Neuro physiotherapy department DR. APJ Abdul Kalam Collage of Physiotherapy Pravara Institute of Medical Sciences Loni Neuro physiotherapy department DR. APJ Abdul Kalam Collage of Physiotherapy Pravara Institute of Medical Sciences Loni Ahmadnagar MAHARASHTRA 413763 India |
| Phone |
9604691665 |
| Fax |
|
| Email |
shubhamphysio8249@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Komal Thorat |
| Designation |
Associate Professor |
| Affiliation |
Pravara Institite of Medical Sciences Loni |
| Address |
Neuro physiotherapy department DR. APJ Abdul Kalam Collage of Physiotherapy Pravara Institute of Medical Sciences Loni Neuro physiotherapy department DR. APJ Abdul Kalam Collage of Physiotherapy Pravara Institute of Medical Sciences Loni Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
9764344584 |
| Fax |
|
| Email |
komal.physio@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shubham Gajare |
| Designation |
PG STUDENT |
| Affiliation |
Pravara Institite of Medical Sciences Loni |
| Address |
Neuro physiotherapy department DR. APJ Abdul Kalam Collage of Physiotherapy Pravara Institute of Medical Sciences Loni Neuro physiotherapy department DR. APJ Abdul Kalam Collage of Physiotherapy Pravara Institute of Medical Sciences Loni Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
9604691665 |
| Fax |
|
| Email |
shubhamphysio8249@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pravara Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
DR. APJ Abdul Kalam Collage of Physiotherapy,pims |
| Address |
DR. APJ Abdul Kalam Collage of Physiotherapy Pravara Institite of Medical Sciences Loni |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrShubham Gajare |
Pravara Rural Hospital |
Department Of Neurophysiotherapy Ahmednagar MAHARASHTRA Ahmadnagar MAHARASHTRA |
9604691665
shubhamphysio8249@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee of Dr. APJ Abdul Kalam COPT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G549||Nerve root and plexus disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Effect of circuit training on aerobic capacity and muscle strength in spinal cord injury |
Control Group
Conventional Exercises
Warm up (Stretching on wheelchair)
Aerobics
Wheelchair dance
Wheelchair propulsion activities.
Forward Propulsion
Backward Propulsion
Advancing with obstacles
(zigzag forward/backward)
Advancing to pick up on objects
Strength Training
By using weight cuffs /Theraband
Key muscles:
Pectoralis muscles
Biceps + Deltoid
Triceps
Trapezius + Latissimus Dorsi + Teres major
|
| Intervention |
Effect of circuit training on aerobic capacity and muscle strength in spinal cord injury |
Experimental Group
Warm up
Arm Ergometer
Shoulder Strength Training
1. Butterfly press
2. Curl back neck
(multifunctional machine)
3. Dumbbell exercises
Front raise
Side raise
Triceps
Shoulder shrug
Cooldown period
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 to 70 years
2. Both male and female
3. Traumatic Sci
4. Participants willing to participate |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
1. Participants with cardiorespiratory conditions
2. Autonomic Dysreflexia
3. Functional Electrical Stimulation evoked exercise
4. Recent osteoporotic fracture
5. Enrolment in another clinical study
6. Un-cooperative patients |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
a. 6 min wheelchair propulsion test
b. ASIA scale
c. 1 Repetition Maximum
|
0 week
6 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/04/2024 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
|
BRIEF RESUME OF
THE INTENDED WORK
INTRODUCTION
Spinal cord injury (SCI) is defined as damage to the
spinal cord that temporarily or permanently causes changes in its function. SCI’s
have devastating physical, social and vocational consequences for patients
and their families, and a loss of independence and persistently increased
lifelong mortality rates are the hallmarks of SCI. More than 90% of SCI cases
are traumatic and caused by incidences such as traffic accidents, violence,
sports, or falls. The Male-to-female ratio of 2:1 for SCI, which happens more
frequently in adults compared to children. Demographically, men are mostly
affected during their early and late adulthood (3rd and 8th decades of life)
while women are at higher risk during their adolescence (15–19 years) and 7th
decade of their lives.
Individuals with SCI are known to be at elevated
risk for cardiopulmonary complications. Various reports have associated this
risk with the sedentary lifestyle and
low levels of fitness observed in
persons. In some cases their limited physical capacities are sufficient to
compromise functional levels necessary for performance of basic daily
activities.2 The loss of somatic and autonomic control results in
a reduction of physical activity and blunted cardiovascular response to
exercise. Consequences of this reduction in physical activity include
detrimental changes in body composition and metabolic profiles leading to
significantly poorer health outcomes in this population.
Physical deconditioning is a state of diminished
strength, stamina, and capacity to perform physical activity. A decline in
strength, endurance, and functional capacity are major health concerns for
the individual living with SCI. As stated before, sedentary behavior and
inactivity are major risk factors for the development of cardiovascular
disease and metabolic disorders and have been linked to decreased muscular
strength, reduced aerobic capacity, and increased disability.12 Muscle
strength is decreased because neurological input to the affected muscles that
retain partial innervation is deficient, leading to the loss of normal
activation timing and force-generating capacity.
|
|
Circuit training (CT) consisting of several
resistance exercises performed in succession, with one set directly followed
by a different resistance maneuver. Rest periods between these maneuvers are
usually kept to a minimum, which keeps the HR elevated throughout the entire
training session. A prescribed number of circuits are then 2 completed for
each training session. The benefits of CT in persons without disabilities are
well established and include greater muscular strength, cardiorespiratory
endurance and aerobic capacity than achieved when performing resistance
training and/or aerobic training alone.
NEED
FOR THE STUDY
Studying
the effects of circuit training on aerobic capacity and muscle strength in
spinal cord injury (SCI) patients is crucial for several reasons. Such research can contribute valuable
insights into developing tailored rehabilitation programs and improving the
overall quality of life for individuals with spinal cord injuries. There is a
scarcity of comprehensive research on the specific effects of circuit training in
the context of spinal cord injuries. A study in this area would help fill the
existing knowledge gap and provide evidence-based guidelines for
rehabilitation. As there is lack of literature combining aerobic and anaerobic
exercises in the form of circuit training.
Hence, need of my
this study is to evaluate the effect
of circuit training on aerobic capacity and muscle strength in spinal cord
injury patients
|
RESEARCH
QUESTION
Will there be any effect of circuit training on
aerobic capacity and muscle strength in spinal cord injury patients?
AIM
AND OBJECTIVES
AIM:
To find the effect of circuit training on aerobic
capacity and muscle strength in spinal cord injury patients.
OBJECTIVES:
1. To
evaluate the effect of circuit training on aerobic capacity in spinal cord
injury patients
2. To
find out the effect of circuit training on muscle strength in spinal cord
injury patients.
|
|
HYPOTHESIS
Null
Hypothesis (H0):
There
will be no significant effect of circuit training on aerobic capacity and
muscle strength in spinal cord injury patients.
Alternative
Hypothesis (H1)
There
will be significant effect of circuit training on aerobic capacity and muscle
strength in spinal cord injury patients.
|
|
|