| CTRI Number |
CTRI/2021/10/037422 [Registered on: 21/10/2021] Trial Registered Prospectively |
| Last Modified On: |
20/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Home Based Rehabilitation On Cardio-Respiratory Fitness In Post Covid-19 Type II Diabetes Mellitus Patients-Randomized Controlled Trail |
|
Scientific Title of Study
|
Effect of home based rehabilitation program on
cardio-respiratory fitness level with post
COVID-19 patients in type II Diabetes
Mellitus-Randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MANISH SHUKLA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
MGM INSTITUTE OF PHYSIOTHERAPY |
| Address |
MGM Institute of Physiotherapy,
Cardio-Respiratory Department,
N 6, CIDCO, Aurangabad
MGM Institute of Physiotherapy,
Cardio-Respiratory Department,
N 6, CIDCO, Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9960290614 |
| Fax |
|
| Email |
manish.shukla20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MANISH SHUKLA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
MGM INSTITUTE OF PHYSIOTHERAPY |
| Address |
MGM Institute of Physiotherapy,
Cardio-Respiratory Department,
N 6, CIDCO, Aurangabad
MGM Institute of Physiotherapy,
Cardio-Respiratory Department,
N 6, CIDCO, Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9960290614 |
| Fax |
|
| Email |
manish.shukla20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MANISH SHUKLA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
MGM INSTITUTE OF PHYSIOTHERAPY |
| Address |
MGM Institute of Physiotherapy,
Cardio-Respiratory Department,
N 6, CIDCO, Aurangabad
MGM Institute of Physiotherapy,
Cardio-Respiratory Department,
N 6, CIDCO, Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9960290614 |
| Fax |
|
| Email |
manish.shukla20@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Institute of Physiotherapy, N 6, CIDCO, Aurangabad |
|
|
Primary Sponsor
|
| Name |
MGM Institute Of Physiotherapy |
| Address |
MGM Cardiorespiratory Physiotherapy OPD NO- 04, MGM Physiotherapy Rehabilitation And Fitness Center, N-6, CIDCO, Aurangabad |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dhanshreee Vinod Dabhade |
MGM Medical College And Hospital |
MGM Cardiorespiratory Physiotherapy OPD NO- 04, MGM Physiotherapy Rehabilitation And Fitness Center,
N 6, CIDCO, Aurangabad
Aurangabad
MAHARASHTRA |
9834206631
dhanashreedabhade672@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGMIOP INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GROUP A- EXPERIMENTAL GROUP- Physical activity like brisk walking, stair climbing, spot marching, healthy diet, lifestyle modifications
GROUP B - CONTROLLED GROUP- Daily routine activity, lifestyle modifications, healthy diet. |
patients will be performing the activity for 30 minutes / day along
with which they will be doing 10 min warm up exercises (arm
circles, side shuffles, spot marching) prior to the activity and 10 min
cool down exercises ( stretching ) after the activity.
Mild to moderate intensity exercise for 3-5 days per week for 150 min per week |
| Intervention |
HOME BASED REHABILITATION PROGRAM |
mild to moderate physical activity which will involve 15
minutes of brisk walking, step up and step down for 5 minutes, spot
marching for 5 minutes and stair climbing- 2 flights |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Post COVID patients who have been medically diagnosed with
type 2 DM.
Age 40-50 years
Post COVID patients who had mild infection, successfully
recovered and tested negative. (Negative RT – PCR )
Patients with normal BMI (18. 5 – 24.9)
Both males and females |
|
| ExclusionCriteria |
| Details |
Patients who had history of ICU stay who were ventilated for
prolong period of time.
Patients who are had the history of chronic diabetes mellitus.
Patients suffering from diabetic retinopathy, diabetic
nephropathy, diabetic neuropathy, fractures.
Pregnant women and women who are lactating |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
VO2 MAX
6 MINUTES WALK TEST
|
AT BASELINE
ON 4TH WEEK
ON 8TH WEEK |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PHYSICAL ACTIVITY RATING QUESTIONNAIRE |
AT BASELINE
ON 4TH WEEK
ON 8TH WEEK |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
22/10/2021 |
| 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="6"
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
|
Title - Effect of home based rehabilitation program on cardio-respiratory fitness level with post COVID-19 patients in type II Diabetes Mellitus-Randomized controlled trial Method - Study design: Randomized Controlled Trail with Parallel Group Design Study setting : MGM Medical College & Hospital, Aurangabad Study population: Post COVID – 19 patients with Type 2 DM Sample size: 70 (35 in experimental group and 35 in controlled group) Study duration: 18 months Sampling technique : Convenient sampling technique Procedure - The study will be conducted after the approval of the ethical committee. GROUP A- EXPERIMENTAL GROUP (n= 35) Physical activity like brisk walking, stair climbing , spot marching, healthy diet, lifestyle modifications. GROUP B- CONTROLLED GROUP (n= 35) Daily routine activity, lifestyle modifications, healthy diet. We will acquire structured data including demographic data which includes (Name, Age, Gender, BMI), past history, personal history, drug history, socioeconomic history and laboratory reports (blood glucose level). The “6 minute walk” test will be performed to check for the fitness level for the patient whether the patient is fit for the study or not in regards to endurance. All the safety measures for COVID 19 will be taken. Guidelines related to COVID 19 will be explained to the patients. The Post COVID 19 patient who has a “Negative RT-PCR” report will be selected.
GROUP A (EXPERIMENTAL GROUP) PROCEDURE: Patients will be explained about the study procedure. Informed consent will be taken by them. In this group the patients will be advised change their sedentary habits, ideas related to life style modification and will also be advised to maintain a healthy diet. Along with these lifestyle modifications, the patients in this group will be performing some home- based rehabilitation program which include mild to moderate physical activity which will involve 15 minutes of brisk walking, step up and step down for 5 minutes, spot marching for 5 minutes and stair climbing- 2 flights. A video- tape will be shared with the patients explaining the various exercises which will help the patients to understand how the exercise will be done. Patients will be asked to install the “PEDOMETER APP” on their mobile phones to maintain the record of their activity. The app shows total number of footsteps walked per day, amount of calories burnt, distance walked, time of walking, weekly report. After the completion of 8 weeks protocol the patient will be assessed for the blood glucose level and cardio-respiratory fitness. The cardio-respiratory fitness will be checked by VO2 max and 6 minute walk test. VO2 max is the Gold Standard to calculate the cardio-respiratory fitness.
GROUP B (CONTROLLED GROUP) PROCEDURE: Patients will be explained about the study procedure. Informed consent will be taken by them. In this group the patients will be advised change their sedentary habits, ideas related to life style modification and will also be advised to maintain a healthy diet.
Outcome measures - 1. VO2 Max 2. 6 Minute walk Test 3. Physical Activity Rating Questionnaire |