| CTRI Number |
CTRI/2025/03/083086 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Aerobic Exercises versus Eccentric Resisted Exercises Combined with Inspiratory Muscle Training on Pulmonary Function, Body Composition, and Blood Glucose Level in Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
Effectiveness of Aerobic Exercises versus Eccentric Resisted Exercises Combined with Inspiratory Muscle Training on Pulmonary Function, Body Composition, and Blood Glucose Level in Type 2 Diabetes Mellitus: 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 SANJEEVANI KADAM |
| Designation |
MASTER OF CARDIOVASCULAR RESPIRATORY PHYSIOTHERAPY |
| Affiliation |
MAHARASHTRA INSTITUTE OF PHYSIOTHERAPY LATUR |
| Address |
OPD Number 17, Cardiovascular Respiratory Physiotherapy Maharashtra Institute Of Physiotherapy, MIMSR Campus, Vishwanathpuram, Ambajogai Road, Latur
Latur
MAHARASHTRA
413531
India |
| Phone |
9834499848 |
| Fax |
|
| Email |
kadamsanjeevani698@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VISHVNATH PAWADSHETTY |
| Designation |
HOD and Professor Cardiovascular Respiratory Department |
| Affiliation |
MAHARASHTRA INSTITUTE OF PHYSIOTHERAPY LATUR |
| Address |
OPD Number 17,Cardiovascular Respiratory Physiotherapy Maharashtra Institute Of Physiotherapy, MIMSR Campus, Vishwanathpuram, Ambajogai Road, Latur
Latur
MAHARASHTRA
413531
India |
| Phone |
9422710990 |
| Fax |
|
| Email |
physiovish@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VISHVNATH PAWADSHETTY |
| Designation |
HOD and Professor Cardiovascular Respiratory Department |
| Affiliation |
MAHARASHTRA INSTITUTE OF PHYSIOTHERAPY LATUR |
| Address |
OPD Number, Cardiovascular Respiratory Physiotherapy Maharashtra Institute Of Physiotherapy, MIMSR Campus, Vishwanathpuram, Ambajogai Road, Latur
Latur
MAHARASHTRA
413531
India |
| Phone |
9422710990 |
| Fax |
|
| Email |
physiovish@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharashtra Institute of physiotherapy,MIMSR Campus Vishwanathpuram, Ambajogai
Road, Latur 413531, India |
|
|
Primary Sponsor
|
| Name |
Maharashtra Institute of Physiotherapy Latur |
| Address |
Maharashtra Institute of physiotherapy,MIMSR Campus Vishwanathpuram, Ambajogai Road, Latur 413531,Inadia |
| Type of Sponsor |
Research institution and hospital |
|
|
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 SANJEEVANI KADAM |
MAHARASHTRA INSTITUTE OF PHYSIOTHERAPY LATUR |
Department Of Cardiovascular Respiratory Physiotherapy Maharashtra Institute of physiotherapy,MIMSR Campus Vishwanathpuram, Ambajogai Road, Latur
Latur
MAHARASHTRA |
9834499848
kadamsanjeevani698@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharashtra Institute of Physiotherapy Latur, Ethical Commitee |
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 |
AEROBIC EXERCISES COMBINED WITH INSPIRATORY MUSCLE TRAINING |
Warm-up: (5-10 minutes),
Aerobic Exercises program: (30 -50 minutes)
Brisk Walking (30 -50 minutes)
Inspiratory Muscle Training:
for
3 series with 10 reps each series 2 min interval overload adjust weekly,
Cool-down: (5-10 minutes) .
|
| Intervention |
ECCENTRIC RESISTED EXERCISES COMBINED WITH INSPIRATORY MUSCLE TRAINING |
Warm-up: (5-10 minutes),
Eccentric exercises:
Static quadriceps exercise, Straight leg raise exercise, Quadriceps extensor exercise, Eccentric knee extension exercise
Inspiratory muscle training
3 series with 10 reps each series 2 min.
|
|
|
Inclusion Criteria
|
| Age From |
33.00 Year(s) |
| Age To |
69.00 Year(s) |
| Gender |
Both |
| Details |
1) Diagnosed case of Type 2 diabetes mellitus
2) Patient who can complete 6 min walk test
|
|
| ExclusionCriteria |
| Details |
1) Acute and chronic inflammatory diseases
2) Pregnancy
3) Smoking
4) Chronic alcoholic and drug addiction
5) Patient who has underwent recent cardiothoracic or abdominal surgery.
6) Recent Musculoskeletal injuries
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)PFT (SP10BT) device: Application (by: Benius Medical System, Faridabad) volume accuracy
+-3% or +-0.05L, flow accuracy +-5% or +-0.2L/S
2) Body composition: Body fat analyzer (Actofit Smart Scale Pro Max) (highest accuracy 80-90%)
3) Blood Glucose Level: Glucometer (Dr. Morepan Glucometer One BG 02) (0.96)
|
At patient enrollment first day 4 th week and 8 th week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient who are able to complete 6 min walk test |
able to complete 6 min walk test |
|
|
Target Sample Size
|
Total Sample Size="111"
Sample Size from India="111"
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)
|
30/04/2025 |
| 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="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
present study will be conducted with permission from the Institutional ethical
committee. Participants will be selected based on inclusion and exclusion
criteria.
The
entire procedure will be explained and informed written consent is taken from
the subjects. The present study involves 111 subjects with age group of 33 to
69 years. After pre-evaluation the participants will be assigned into 3 groups according
to simple random sampling.
Group
A receiving Aerobic exercises combined with inspiratory muscle training. Group
B receiving eccentric resisted exercises combined with inspiratory muscle
training Group C receiving inspiratory muscle training. all three groups
will be given 10 min of warm-up at the start of intervention and 10 minutes of
cool-down at the end of intervention. The patients will be assessed prior, at
the end of 4th week and at the end of 8th week by
assessing their pulmonary function (by Spirometer SP10BT), body composition (by
body Fat analyzer) and blood glucose levels (by glucometer).
The
exercise protocol will be carried out for 3 days per week, for 8 weeks to all
three groups. |