| CTRI Number |
CTRI/2024/07/070736 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
07/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find correlation of six minute walking performance with quality of life in old people aged 60 years and above |
|
Scientific Title of Study
|
Correlation of 6 minute walking performance with Quality of Life in Geriatric Population |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AIIMSG/IEC/M5/P17/2024 Dated: May 31, 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saptarshi Hazra |
| Designation |
Post Graduate Trainee |
| Affiliation |
All India Institute of Medical Sciences Guwahati |
| Address |
Department of Physical Medicine and Rehabilitation
All India Institute of Medical Sciences
Guwahati Changsari
Kamrup
ASSAM
781101
India |
| Phone |
9007521277 |
| Fax |
|
| Email |
dr.saptarshihazra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prof Diganta Borah |
| Designation |
Professor and Head of the Department of Physical Medicine and Rehabilitation |
| Affiliation |
All India Institute of Medical Sciences Guwahati |
| Address |
Department of Physical Medicine and Rehabilitation
AIIMS Guwahati
Kamrup
ASSAM
781101
India |
| Phone |
7503005456 |
| Fax |
|
| Email |
digantaborah@aiimsguwahati.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prof Diganta Borah |
| Designation |
Professor and Head of the Department of Physical Medicine and Rehabilitation |
| Affiliation |
All India Institute of Medical Sciences Guwahati |
| Address |
Department of Physical Medicine and Rehabilitation
AIIMS Guwahati
Kamrup
ASSAM
781101
India |
| Phone |
7503005456 |
| Fax |
|
| Email |
digantaborah@aiimsguwahati.ac.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences
Guwahati Changsari
Assam 781101
India |
|
|
Primary Sponsor
|
| Name |
Saptarshi Hazra |
| Address |
Department of Physical Medicine and Rehabilitation
All India Institute of Medical Sciences
Changsari Guwahati
Assam 781101 |
| 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 Saptarshi Hazra |
All India Institute of Medical Sciences Guwahati |
Out Patient Department of Physical Medicine and Rehabilitation
Kamrup
ASSAM |
9007521277
dr.saptarshihazra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Guwahati |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
QUALITY OF LIFE IN GERIATRIC POPULATION |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Age 60 years and above
Individuals not involved in any competitive sports
Subjects independent in basic activities of daily life
|
|
| ExclusionCriteria |
| Details |
Individuals with significant visual or hearing impairment
Uncontrolled hypertension or diabetes mellitus
Symptomatic cardiopulmonary disease
Severe renal or hepatic disease
Uncontrolled epilepsy
Progressive neurological disease
Chronic debilitating arthritis, low back pain
Present acute or terminal illness
Use of walking aids
Any neurological, skeletal muscle or joint disturbance significantly affecting activities of daily life (ADL)
Inability to provide proper response to the Quality of life questionnaire
Individuals with history of smoking, alcohol and drug abuse
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Six minute walking distance in meters
2. Quality of Life as per Short Form 36 Health Survey score |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of Six Minute Walking Performance with Quality of Life |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="101"
Sample Size from India="101"
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)
|
01/08/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study titled "Correlation of 6 minute walking performance with Quality of Life in Geriatric Population" is a single centred, cross-sectional, observational study to be held at Department of Physical Medicine and Rehabilitation, AIIMS Guwahati for a period of two years. The study aims to correlate the performance in 6 minute walk test with Quality of Life in geriatric population aged 60 years and above. The study will measure the performance in 6 minute walk test in terms of total distance covered in meters and assess the quality of life in terms of SF 36 scores, and thereby the two variables will be correlated to assess the applicability of 6 minute walk test as a predictor of Quality of Life in geriatric population. After informed consent and initial health assessment, the participants would be asked to fill up the pre-validated, free to use SF-36 Questionnaire. After the test, the 6 minute walking distance would be recorded as per American Thoracic Society Guidelines, and performance would be correlated with the SF 36 responses to find association. The study does not involve any intervention or randomization.Confidentiality of subjects would be maintained as per ICMR Guidelines. Both Participant Information Sheet and Informed Written consent will be in English, Hindi And Assamese language (language preferred by the participant). The estimated sample size of the study is 101. Statistical analysis will be done by suitable tests like frequency percentage, Student’s t-test, Chi Square test, Pearson Correlation coefficient and Spearman rank correlation with a p value of less than 0.05 to be considered statistically significant. The study involves less than minimal risk. There is no conflict of interest. |