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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
18-45 year old healthy adults |
|
Intervention / Comparator Agent
|
|
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). |