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CTRI Number  CTRI/2020/12/029861 [Registered on: 16/12/2020] Trial Registered Prospectively
Last Modified On: 07/12/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Usefulness of the instrument- hand grip dynamometer- for testing muscle fatigability in healthy adults 
Scientific Title of Study   Utility of electronic hand grip dynamometer for testing muscle endurance in healthy human volunteers 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vangaveti Sneha 
Designation  Senior Resident 
Affiliation  AIIMS, New Delhi 
Address  Department of Pharmacology, 4th floor, Teaching Block, All India Institute of Medical Sciences (AIIMS)

South
DELHI
110029
India 
Phone  9884361372  
Fax    
Email  sneha.vanag@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr V L Kumar 
Designation  Professor and Head 
Affiliation  AIIMS, New Delhi 
Address  Department of Pharmacology, 4th floor, Teaching Block, All India Institute of Medical Sciences (AIIMS)

South
DELHI
110029
India 
Phone  9205913266  
Fax    
Email  kumarvl98@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr V L Kumar 
Designation  Professor and Head 
Affiliation  AIIMS, New Delhi 
Address  Department of Pharmacology, 4th floor, Teaching Block, All India Institute of Medical Sciences (AIIMS)

South
DELHI
110029
India 
Phone  9205913266  
Fax    
Email  kumarvl98@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi 
 
Primary Sponsor  
Name  Dr Vangaveti Sneha 
Address  Department of Pharmacology, 4th floor, Teaching Block, All India Institute of Medical Sciences (AIIMS), New Delhi-29 
Type of Sponsor  Other [Self] 
 
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 
Dr Vangaveti Sneha  AIIMS, New Delhi  Room No. 5005, Convergence Block, Department of Pharmacology, AIIMS, New Delhi-110029
South
DELHI 
9884361372

sneha.vanag@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  18-45 year old healthy adults  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Participants aged 18-45 years of either gender
2. Participants free from any impairment in either limb for at least 12 months prior to the study
3. Participants willing to participate and give informed written consent 
 
ExclusionCriteria 
Details  1. Participants with BMI > 30 kg/m2
2. Participant with any history of medication intake for chronic illnesses
3. Participants with history of extensive use of either limb/ evidence of hypertrophy of limb muscles
4. Inability to understand given instructions
5. History of excessive intake of alcohol (equivalent to or more than 40 g per day), tobacco (equivalent to or more than half a pack of cigarettes per day), coffee, tea or drinks containing caffeine (equivalent to more than 4 cups per day)
6. Pregnant or lactating women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the correlation between muscle endurance parameters evaluated by six-minute walk test (6MWT, distance walked), push up test (number performed) and electronic hand grip dynamometer (duration of grip for each variation/fatigue index) in healthy human volunteers  Baseline (day 0), 1 week and 2 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate and compare the effect of physiological differences (age, gender, body-mass index, body composition and physical activity) on muscle endurance parameters evaluated using six-minute walk test (6MWT), push up test and hand grip dynamometry  Baseline (Day 0), 1 week and 2 weeks 
To assess the repeatability of hand grip dynamometry (standardized protocol according to primary objective) for evaluating muscle endurance in healthy human volunteers  Baseline (day 0), 1 week and 2 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/01/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Muscle strength as well as endurance have been highlighted as important components associated with health-related fitness in individuals of all age groups. On one hand, muscle strength is the ability to exert maximal force whereas muscle endurance refers to the ability to perform prolonged muscular work at predetermined intensity without external signs of fatigue. These two indices, when taken together, have been shown to provide an almost complete measure of muscle performance. There has been an increasing focus on the interchangeability of muscle performance related tests in conditions of age-related, disease-related or resource-related constraints. Modified methods often need to be validated and correlated with the existing reliable methods in order to utilize these alternative testing options. The hand grip dynamometer is a simple instrument that has been used widely for evaluating muscle strength and in more recent times, muscle endurance. There is lack of a standard protocol for evaluating muscle endurance in these studies employing dynamometry. Moreover, these protocols have not been correlated with any existing methods used for upper limb endurance testing. Therefore, it has been planned to establish and validate a standard protocol for evaluating muscle endurance using hand grip dynamometer.

The aim of the present study is to evaluate whether hand grip dynamometer can be used to test muscle endurance in adults. Participants who meet the inclusion and exclusion criteria will be further screened before the main study. The general information, anthropometric measurements and physical examination findings will be recorded for each participant during the screening visit. The physical activity and cardiorespiratory fitness will also be evaluated for all eligible participants during this visit. Only those participants who fall in low or moderate category of physical activity and whose values of maximal oxygen uptake fall within a specified range (30-60 mL/kg/min) will be considered eligible for the main study. For the main study, after following adequate precautions, each participant will have to perform 3 tests for muscle endurance:
1. Six-minute walk test (6MWT): Participants will be asked to walk for 6 minutes at their own pace while being monitored closely. The distance walked will be taken as the endpoint.
2. Push-up test: Depending upon their gender, participants will be asked to perform push-ups according to the standard protocol (men) or modified protocol (women) till exhaustion. The number of push-ups will be taken as the endpoint.
3. Hand grip dynamometry: After explaining the testing position for electronic hand grip dynamometer, different protocols will be employed to assess the static as well as dynamic muscle endurance. 
a) Static endurance: Duration for which the participant can maintained a desired target contraction (either 50% or 60% of maximum voluntary contraction) will be taken as endpoint.
b) Dynamic endurance: Two approaches for evaluating dynamic endurance will be used. First, each participant will be asked to repeatedly squeeze the dynamometer at a fixed rate till exhaustion (duration will be taken as endpoint). Second, participants will be instructed to squeeze the dynamometer will maximal effort for 8,10 or 12 repetitions at 15 second intervals (fatigue index will be taken as endpoint). 

Adequate precautions will be taken during the conduct of each study and participants will be given sufficient rest period between different tests. The levels of perceived exertion (using Borg CR-10 scale) and muscle soreness (using visual analogue scale) will be evaluated before the start of and immediately after each test. For evaluating repeatability, all tests will be repeated twice in the same order in the following 4 weeks (ensuring at least one-week
interval between each visit).
 
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