| 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
|
|
|
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. |