| CTRI Number |
CTRI/2024/02/062484 [Registered on: 09/02/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Validation of a fitness band in healthy individuals. |
|
Scientific Title of Study
|
Validation of wearable in free living healthy individuals. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sara Manohar Malpe |
| Designation |
BPT intern |
| Affiliation |
Manipal College of Health Professionals |
| Address |
Dept of Physiotherapy,
MCHP, MAHE, Manipal
Udupi
Udupi
KARNATAKA
576101
India |
| Phone |
9632475605 |
| Fax |
|
| Email |
sara.malpe@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Sara Manohar Malpe |
| Designation |
BPT intern |
| Affiliation |
Manipal College of Health Professionals |
| Address |
Dept of Physiotherapy,
MCHP, MAHE, Manipal
Udupi
KARNATAKA
576101
India |
| Phone |
9632475605 |
| Fax |
|
| Email |
sara.malpe@learner.manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sara Manohar Malpe |
| Designation |
BPT intern |
| Affiliation |
Manipal College of Health Professionals |
| Address |
Dept of Physiotherapy,
MCHP, MAHE, Manipal
Udupi
KARNATAKA
576101
India |
| Phone |
9632475605 |
| Fax |
|
| Email |
sara.malpe@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Heart Failure Association of India HFAI |
|
|
Primary Sponsor
|
| Name |
Heart Failure Association of India HFAI |
| Address |
Room no. 1212, Medical block second floor, Department of Cardiology, Sree Chitra Tirunal Institute for Medical Sciences and technology, Medical College campus trivandrum Kerala 695011 |
| Type of Sponsor |
Government funding agency |
|
|
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 Abraham Samuel Babu |
Department of Cardiothoracic and vascular surgery Cardiac Rehabilitation Clinic |
Cardiac Rehabilitation Clinic Department of Physiotherapy Room number 32 third floor Department of Cardiovascular and Thoracic Surgery Kasturba Hospital
Manipal
Udupi
KARNATAKA |
9742502838
abrahambabu@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Kasturba medical College and kasturba hospital institutional ethics committee-2 |
Approved |
| Kasturba medical College and kasturba hospital institutional ethics committee-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)With no self reported comorbidities
2)Above the age of 18 years
3)Either gender
|
|
| ExclusionCriteria |
| Details |
1)Patients with neuromuscular diseases for whom ambulation is not possible
2)Participants who use walking aids
3)Participants with psychological impairments that can affect assessment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of steps taken during six minute walk test |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Distance covered during six minute walk test |
Baseline |
|
Target Sample Size
Modification(s)
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/02/2024 |
| Date of Study Completion (India) |
31/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Introduction: Physical inactivity is the fourth biggest risk factor for worldwide mortality. Walking is the most practical approach to be active because it can be done by anybody and everywhere. Standardised physical activity monitoring during hospitalisation is a tangible solution, it raises awareness of physical inactivity while also serving as an input to evaluate and improve individual patients’ physical activity levels.
Gaps:Research shows validation of older versions of Mi band but there is lack of study showing validation of Mi band 6. Limited studies have demonstrated Validity of Mi-Band in healthy individuals.
Need:Promoting physical activity by increasing step count
Objective: To determine the level of agreement of step count and distance covered using Mi band and direct visualization during 6MWT in healthy individuals |