| CTRI Number |
CTRI/2023/08/056418 [Registered on: 11/08/2023] Trial Registered Prospectively |
| Last Modified On: |
10/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Exercise and education program for elderly with Diabetes using technology |
|
Scientific Title of Study
|
Effect of a comprehensive rehabilitation program using digital technology on lower extremity function and quality of life in community-dwelling older adults with type 2 Diabetes Mellitus |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tina Agnes |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Centre for Diabetic Foot Care and Research, Department of Physiotherapy,
2nd floor
Manipal College of Health Professions,
Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9740688454 |
| Fax |
|
| Email |
tina.agnes@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Tina Agnes |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Centre for Diabetic Foot Care and Research, Department of Physiotherapy,
2nd floor
Manipal College of Health Professions,
Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9740688454 |
| Fax |
|
| Email |
tina.agnes@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Arun Maiya |
| Designation |
Dean and Professor |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Dean-Manipal College of Health Professions,
Chief- Centre for Diabetic Foot Care and Research
Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845350823 |
| Fax |
08202571915 |
| Email |
arun.maiya@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions |
| Centre for diabetic foot care and research and Kasturba hospital |
|
|
Primary Sponsor
|
| Name |
Department of Health Research |
| Address |
Ministry of Health and family welfare, Department of Health Research, 2nd floor, red cross road, New Delhi-110001 |
| 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 |
| Tina Agnes |
Centre for Diabetic Foot Care and Research |
Room number- 4, Centre for Diabetic foot care and research, Department of Physiotherapy, First floor, N Block, Kasturba Hospital, Manipal, Udupi, Karnataka-576104
Udupi
Udupi
KARNATAKA |
08202923054
tina.agnes@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comprehensive Rehabilitation program delivered through digital technology (Mobile application) |
Comprehensive Rehabilitation program will include exercise intervention delivered through the mobile application will consist of general flexibility exercises, Low to moderate intensity aerobic exercises, strengthening exercises, Advice on foot care & footwear and health education material related to lifestyle delivered through and mobile application. The total duration of this intervention will be 12 weeks |
| Comparator Agent |
Standard care |
Control group will be receiving standard care prescribed by the physician and advice on being active by the physiotherapist and general foot care and advice on footwear
The total duration of standard care will be 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Older adults between 60 to 75 years
Minimum duration of type 2 Diabetes mellitus - one year
5 repetitions sit to stand test score above 11.6 seconds
Older adults with functional vision & hearing
Participants using an android based smartphone or primary informal caregiver who is living with the older adult has a smartphone with android version 4.0 or above
Participants who can read and comprehend Kannada or English
Have internet access on smartphone through Wi-Fi/Mobile data
Either gender
Able to ambulate independently without walking aids
|
|
| ExclusionCriteria |
| Details |
Older adults who are immobile
Any neurological impairment (eg: Stroke, Parkinsonism) which can impair mobility
Individuals with open foot ulcers
Any Chronic or Acute injury which could affect participation in the rehabilitation program
Cognitive impairment (Mini Cog score of 2 or less than 2)
Uncontrolled hypertension
Any major cardiac event in the past 6 months
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. lower extrimity function- Lower Extremity functional scale (LEFS), walking performance & functional capacity using 6 minute walk distance, Mobility using Timed up & go test, gait speed, lower extremity strength & balance using Short physical performance battery & flexibility using sit and reach test
2. Quality of Life using SF-36 |
Before the intervention & 12 weeks after |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Physical activity - Global physical activity questionnaire (GPAQ)
Behavioral changes related to foot care (Knowledge & Practice of footcare)-Nottingham Assessment of Functional Footcare (NAFF)
Fear of fall- Falls efficiency scale – International (FES-I)
Neuropathic pain- DN-4 questionnaire
Glycemic parameters- FBS and HbA1c
|
Before the intervention & 12 weeks after |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
21/08/2023 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The aim of this study is To develop and test the effects of a comprehensive rehabilitation program delivered through digital technology on lower limb function and quality of life in community dwelling older adults with type 2 Diabetes Mellitus. This study is divided into two phases: phase 1 is the Design, Development and validation of a mobile health application for the delivery of a comprehensive rehabilitation program for community-dwelling older adults with type 2 DM and phase 2 is a randomized controlled trial to look at the Effect of a comprehensive rehabilitation program delivered through a mobile health application on lower extremity function and quality of life in community dwelling older adults with type 2 DM. Digital technology in terms of use mobile phones is becoming an important tool and the healthcare sector has seen a paradigm shift towards digital health. The benefits include time and cost savings, shortened waiting time and improved quality of life.The use of digital technology is emerging as a way of delivering exercises. Such interventions can aid elderly in exercising at their preferred time and location. Currently there is limited understanding and evidence on the effect of use of smartphones for the delivery of exercises in older adults with type 2 DM. If digital interventions can be proven effective, Comprehensive rehabilitation interventions delivered through digital technology can be prescribed to older adults with type 2 DM, increasing the reach to a wider population. Hence through this study, we will study the effects of a comprehensive rehabilitation program using digital technology on lower extremity function and quality of life in community-dwelling older adults with type 2 DM |