FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/10/074835 [Registered on: 07/10/2024] Trial Registered Prospectively
Last Modified On: 05/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Physical Activity and Exercise]  
Study Design  Other 
Public Title of Study   Comparing Low-Intensity Aerobic Exercise with Blood Flow Restriction to High-Intensity Interval Training: Effects on Fitness in Untrained People 
Scientific Title of Study   Low-intensity aerobic training with blood flow restriction versus high-intensity aerobic interval training on anaerobic parameters in untrained individuals: quasi-experimental study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vedith M D 
Designation  MSc. Student 
Affiliation  Manipal College of Health Professions 
Address  Department of Exercise and Sports Sciences, MCHP, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8762100628  
Fax    
Email  vedith123devang@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mr Tulasiram B 
Designation  Assistant Professor- Senior Scale 
Affiliation  Manipal College of Health Professions 
Address  Department of Exercise and Sports Sciences, MCHP, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9738034067  
Fax    
Email  tulasiram.b@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Mr Tulasiram B 
Designation  Assistant Professor- Senior Scale 
Affiliation  Manipal College of Health Professions 
Address  Department of Exercise and Sports Sciences, MCHP, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9738034067  
Fax    
Email  tulasiram.b@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal-576104. 
 
Primary Sponsor  
Name  Department of Exercise and Sports Sciences 
Address  Department of Exercise and Sports Sciences, MCHP, Manipal 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Mr Vedith M D  Department of Exercise and Sports Sciences, MCHP, Manipal 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mr Vedith M D  Center for Sports Science, Medicine and Research  Floor -5, Marena Sports Complex, Marena Road, Madhav Nagar, Eshwar Nagar, MAHE, Manipal, Karnataka- 576104
Udupi
KARNATAKA 
8762100628

vedith123devang@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KMC and KH Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  NIL 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  High Intensity Aerobic Interval exercise training  Set of exercises designed in a way to modulate the perceived exertion during exercise. Jumping Jacks, Burpees, Mountain climbers, Inchworm, Air squats, High Knees. All the exercises listed will be performed as many repetitions possible for 30 seconds with rest in between for 3 sets. (Approximate 15 minutes)  
Intervention  Low intensity Exercise with Blood flow restriction cuffs  Overground walking at comfortable pace with Blood flow restriction cuff tied on the upper thigh (both legs) at 60% of Leg Occlusion Pressure (LOP) for 15 minutes.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Not trained since last 6 months.
Those who can dedicate time to the intervention program.
Non-smokers and Non-alcoholic drinkers.  
 
ExclusionCriteria 
Details  Individuals suffering from any respiratory disease.
Individuals suffering from any Cardiovascular disease.
Individuals suffering from any vascular disease.
Individuals who underwent any surgeries in the past 6 months.
Individuals complaining of pain or any significant injury in the past 6 months. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Anaerobic Power (Mean power, Average power and Maximum power)-Watts  Baseline and Post-intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Muscle endurance- Number of repetitions in 2 minutes  Baseline and Post-intervention 
Muscle power- Watts  Baseline and Post-intervention 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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)   16/10/2024 
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="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  
Primary objective: To compare the effects of Low-intensity aerobic training with blood flow restriction on anaerobic power and capacity versus High-intensity aerobic interval training in untrained individuals.
Secondary objective: To compare the effects of Low-intensity aerobic training with blood flow restriction versus high-intensity aerobic interval training on muscle endurance and power in untrained individuals.
Justification for study: 1. This research will provide a clear, descriptive reference to design a Blood Flow Restriction aerobic training program for an untrained individual.
2. The time-efficiency, load-efficient, and lesser exertion effects of Blood Flow Restriction Training will help untrained individuals perform consistent exercise.
3. There are limited studies on studying the effects of Blood Flow Restriction Training on anaerobic capacity and muscle endurance in untrained populations, and no studies compare the effects of walk training with Blood Flow Restriction and traditional High-Intensity Interval Training.
After IEC and IRC approval, CTRI registration and approval will be obtained. All the participants will undergo these tests before and after the intervention/exercise program to obtain the baseline and post-intervention test results, respectively. The tests will be performed: 1. Wingate Anaerobic Test  2. Squat Test  3. Standing Vertical Jump Test
The participant recruitment process begins with screening and assessing the participants for their eligibility, after excluding the participants who do not match the inclusion criteria, denied participation, or denied providing consent of participation. Depending on their convenience, the participants will be divided into Low-Intensity aerobic training with a BFR group (LI-BFR) or a High-Intensity aerobic interval training group (HIIT). Both groups are equally divided into the required sample size. The familiarization of the tests will be performed for all the participants. The participants of the LI-BFR group are familiar with BFR cuffs, and occlusion pressure is determined using the VALD Digital Air Band (BFR Cuffs). These cuffs will be tied on the proximal-most part of the lower limb and inflated to record the resting Blood pressure of the limb in the supine position. The baseline/ pre-testing will be performed after 48 hours of familiarization. The intervention for both groups will begin after 48 hours of pre-testing. In the LI-BFR group, the participants will perform ground walking with BFR cuffs inflated for 60% leg occlusion pressure (LOP) for 15 minutes. This will be continuous, comfortable pace walking, which will be supervised throughout to maintain the RPE at 6-8.
In the HIIT group, the participants will perform a set of exercises for 3 sets, each exercise lasting 30 seconds with as many repetitions as possible. After each exercise, 5 seconds and after each set, 30 seconds of rest will be incorporated. This protocol will be supervised throughout to alter the RPE between 12-18. Standardized warmup and cooldown exercises will be demonstrated and applied. The exercises include Jumping Jacks, Burpees, Mountain climbers, Inchworm Air squats, and High Knees.
The intervention will continue for 6 weeks, 4 sessions/week (24 sessions). The intervention session will last up to 15 minutes. After 48 hours of intervention completion, the post-testing will be performed. As the participants are untrained, the intervention will be supervised, and proper care will be taken of the participants. Since the exercise intervention is supervised, there is a minimal risk of injury occurring. If there is any injury, the student researcher is well-equipped to manage the acute injury. Participants are prone to muscle cramps, muscle aches/muscle soreness,/Delayed Onset of Muscle Soreness. The participants will be advised to use a hot water bag application after every session to minimize the effect of muscle soreness. As PI is a healthcare provider, immediate care will be provided to the participants who experience discomfort during the session. An optimal amount of muscle spray(diclofenac) and a first aid kit will be available if necessary.
The participants will receive a baseline report on their health/physical parameters like anaerobic capacity, muscle endurance, and power. These metrics can help them understand the necessity of performing the exercise and motivate them to be consistent in it. The participants will get a well-planned, supervised exercise routine for 6 weeks, which they can further pursue on their own. They can benefit from supervised physical activity and exercise during the intervention, which helps them learn proper form and posture. The exercise program and post-intervention test will help them understand how the intervention/exercise program has helped them to improve their health. Even during the intervention of 6 weeks, the participants can experience the effects of regular exercise, which motivates them to be consistent.
 
Close