| CTRI Number |
CTRI/2024/01/062134 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
26/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing muscle strength and endurance of thigh muscles in individuals with long term heart disease and healthy adults of same age, gender and body size. |
|
Scientific Title of Study
|
Comparison of Peripheral Muscle Strength and Endurance in Chronic Heart Failure Patients and Age, Gender, Body Mass Index Matched Healthy Controls – A Comparative 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 |
Dr Rachna Arora |
| Designation |
Assistant Professor (PT) |
| Affiliation |
Topiwala National Medical College and B.Y.L Charitable Hospital |
| Address |
OPD no.24,Physiotherapy School and Centre, Topiwala National Medical College and Dr B.Y.L Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central, Mumbai, Maharashtra.
Mumbai
MAHARASHTRA
400008
India |
| Phone |
07738095911 |
| Fax |
|
| Email |
rachna2arora@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rachna Arora |
| Designation |
Assistant Professor (PT) |
| Affiliation |
Topiwala National Medical College and B.Y.L Charitable Hospital |
| Address |
OPD no.24,Physiotherapy School and Centre, Topiwala National Medical College and Dr B.Y.L Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central, Mumbai, Maharashtra.
Mumbai
MAHARASHTRA
400008
India |
| Phone |
07738095911 |
| Fax |
|
| Email |
rachna2arora@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gouri Mahadeorao Satpute |
| Designation |
Post Graduate Student |
| Affiliation |
Topiwala National Medical College and Dr B.Y.L , Charitable Hospital |
| Address |
OPD no.24,Physiotherapy School and Centre, Topiwala National Medical College and Dr B.Y.L, Charitable Hospital, Dr A.L,Dr Anandrao Nair Marg, Mumbai Central,Mumbai,Maharashtra.
Mumbai
MAHARASHTRA
400008
India |
| Phone |
8805938324 |
| Fax |
|
| Email |
gourisatpute327@gmail.com |
|
|
Source of Monetary or Material Support
|
| Topiwala National Medical College and Dr B.Y.L Charitable Hospital |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 Rachna Arora |
B.Y.L. Nair Charitable Hospital, Mumbai. |
Intensive Cardiac Care Unit (ICCU), Ground floor,OPD Building,Topiwala National Medical College and Dr B.Y.L Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central, Mumbai, Maharashtra.
Mumbai
MAHARASHTRA |
7738095911
rachna2arora@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Academic Research Projects (ECARP) PG Academic Committee T.N.Medical College and B.Y.L Nair Ch Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I501||Left ventricular failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A: Chronic heart failure patients.
Group B: Normal healthy individuals (Age, gender and BMI matched) |
A)Procedure of measuring quadriceps strength using hand held dynamometer-
Hand held dynamometer will be used to obtain an isometric measure of quadriceps
muscle performance of both lower extremities. Subjects will be seated at the edge of
the treatment table , with the knees in 60 degrees of knee flexion as measured by universal goniometer. This angle is chosen because it represents the average angle of maximal peak force of quadriceps muscle group. The thigh will be stabilized using a strap. The hand-held dynamometer will be positioned two finger widths above the lateral malleolus on the anterior aspect of the tibia. Subjects will be asked to place their arms across their chest while performing isometric knee extension contractions. Subjects will be instructed to apply 100 percent effort for 3 seconds. Best of three trials will
be selected.
B)Procedure of one minute sit to stand test (1-min STST)-
Pre- test vitals like blood pressure, heart rate, SpO2, rate of perceived exertion will be measured and recorded. The one minute sit to stand test will be performed on a
standard-height chair with a seat height of 18 inches (45cm). The test will be started in a seated position with the subjects back supported and hip and knees in 90-90 degrees of flexion with feet resting flat on ground hip width apart. Participants will be instructed to cross their arms and fold them across their chest and to perform stand and sit transitions on the chair as many times as possible within 1 minute. When the time of the test will elapse, the participant will be instructed to stop and the number of completed STS repetitions will be recorded manually. Post-test vitals will be measured immediately after the test and after three minutes recovery.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
For Study Group
1) Chronic heart failure patients for more than 3 months and NYHA class 1 and 2 on OPD basis.
2) Age between 18-65 years males and females.
3) LVEF less than 40% on 2D echo.
For Control Group
1) Age, gender and BMI matched healthy individuals
|
|
| ExclusionCriteria |
| Details |
For Study Group
1) History of hospital stay in past 3 months.
2) Uncontrolled hypertension with systolic BP more than 140 mm Hg and diastolic BP more than 90
mm Hg and resting heart rate more than 100 beats per minute.
3) Class 3 and Class 4 Angina on NYHA scale.
4) Recent STEMI or Acute coronary syndrome NSTEMI.
5) Patient with any Obstructive Coronary Artery Disease which has not been revascularized.
6) Patients with possible statins Intolerance.
7) Patient with severe pulmonary hypertension.
8) Patients with conduction blocks (Grade 1,2,3).
9) Patients with Complex Arrythmias.
10)Patients unable to understand and follow the verbal commands.
11) Patient with any pre-existing musculoskeletal, neurological problems.
12) Patients with any underlying lung pathology or abnormality.
For Control Group
1)Systolic blood pressure more than 140 mmHg and less than 100 mmHg.
2)Resting DBP more than 90 mmHg.
3)Resting HR more than 100 bpm .
4)Subjects with any co-morbidities like hypertension, diabetes, any underlying lung
pathology.
5)Subjects with any pre-existing musculoskeletal or neurological problems.
6)Subjects with Hypothyroidism.
7)subjects with long term use of statins.
8)Subjects who are unable to understand and follow verbal commands. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Quadriceps Strength (Handheld Dynamometer)
2) Lower Limb Endurance (1 minute sit to stand repetitions) |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2024 |
| Date of Study Completion (India) |
10/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/08/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Heart failure is prevalent globally, and is associated with increased risk of mortality with increased risk of hospitalization and high health care costs. The aim of this study was to compare the peripheral muscle strength ( Right and left Quadriceps strength) and endurance (1MSTS) in chronic heart failure patients (Group A) and age, gender, body mass index matched healthy controls (Group B) . 30 Chronic heart failure patients (Group A) and 30 age, gender, and BMI matched healthy controls (Group B ) completed the study. Right and Left Quadriceps strength was measured using Hand-held dynamometer. Quadriceps endurance was measured using 1MSTS. Statistically significant reductions were found in peripheral muscle (Right and left quadriceps) strength and endurance (1MSTS repetitions). Thus, the study concluded that the peripheral muscle strength and endurance were reduced in Chronic heart failure patients as compared to age, gender and BMI matched healthy controls. |