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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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