| CTRI Number |
CTRI/2024/03/063667 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| 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
|
Benefits of exercise on blood sugar level post exercises |
|
Scientific Title of Study
|
Effect of resistance exercise on blood glucose level in patient 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 |
Prachi Thorat |
| Designation |
Intern |
| Affiliation |
Dr Apj Abdul Kalam College Of Physiotherapy |
| Address |
Dr Apj Abdul Kalam College Of Physiotherapy Loni
Pravara Institute of Medical Sciences.
Department of orthopedic physiotherapy
OPD no.403
Loni Maharashtra
Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
8828143929 |
| Fax |
|
| Email |
prachithorat0077@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sukhpreet Pabla |
| Designation |
Assistant Professor |
| Affiliation |
Dr Apj Abdul Kalam College Of Physiotherapy |
| Address |
Pravara Institute Of Medical Sciences.
Dr Apj Abdul Kalam College Of Medical Sciences.
Orthopaedic Physiotherapy Opd
Tal Rahata District Ahmednagar Loni Maharashtra
Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
9638299273 |
| Fax |
|
| Email |
pablasukhpreet27@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Prachi Thorat |
| Designation |
Intern |
| Affiliation |
Dr Apj Abdul Kalam College Of Physiotherapy |
| Address |
Dr Apj Abdul Kalam College Of Physiotherapy Loni
Department of Orthopedic physiotherapy
OPD no.403
Loni Maharashtra
Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
8828143929 |
| Fax |
|
| Email |
prachithorat0077@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Apj Abdul Kalam College Of Physiotherapy, Loni ,Taluka- Rahata, District Ahmednagar Pin-413736
|
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| 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 |
| Dr Prachi Thorat |
Dr Apj Abdul Kalam College Of Physiotherapy |
Opd no 403 Department Of Orthopaedic Physiotherapy fourth floor Dr Apj Abdul Kalam College Of Physiotherapy Ahmadnagar MAHARASHTRA |
8828143929
prachithorat0077@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL 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 |
Conventional Protocol |
1.Hot water fermentation
Frequency - 2 times per day
for 3 days per week.
Duration - 10 min
2.Transcutaneous Electrical Nerve Stimulation
Frequency - 3 days per week
10hz and 5 mA
Intensity - As per tolerance
Time - 7 min
Type - Acupuncture Tens
3.Strecthing for upper limb, lower limb
Frequency - 3 times per week
duration - 30 sec hold
4 set
15 sec relaxation
period
4.Aerobic exercise (walking, cycling ).
Frequency - 3 days per week
Duration - 30 min
5.Strengthening exercise
Frequency - 3 times per week
8 to 10 reps
2- 3 reps
Intensity - moderate
Duration - 10 min per session
Type - Resistance Band.
The protocol will be 3 days per week for 4 weeks for 40 to 50 min.
|
| Intervention |
Structured Protocol |
Exercise protocol will be of 40 Minutes.
Subjects will be undergoing the exercise session for 40 min for 3days per week for the period of 4 weeks.
The exercise regimen will be consisted of 5mins warm up session which included brisk walking , curl ups, neck rotations and gentle stretching.
30 min intervention phase
Upper limb and lower limb patterns was administered in standing, resistance was given through weight cuff (weights cuff were selected ranging from least resistance i.e 0.5 kg to 2kg.) based on 10 RM
According To FITT Principle -
F - 3days /week (alternate days alternate muscle group )
I- moderate intensity 40% to 60% of 10 RM
T- 30 min
T- weight cuff
Upper Limb Muscles -
1. Trapezius
2.Biceps
3.Triceps
4.Pectoralis major
Lower Limb Muscles -
1. Quadriceps
2. Hamstrings
3. Calf
4. Glutei
Cool Down Phase:
Strechings for the same muscles will be given.
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing to participate
2.Patients diagnosed with type 2 DM with HbA1c ≥ 6.4
3.BMI ≥ 23 kg/m2
4.Patient able to perform 10RM using weight cuff
5.Patients hand grade 3 in MMT |
|
| ExclusionCriteria |
| Details |
Cardiac disorders such as coronary artery disease atrial fibrillation
Respiratory disorders
Patient not willing to participate
Orthopaedic Abnormalities |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Glycosylated Haemoglobin(HbA1c) |
Data will be recorded baseline and fourth week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Repitition maximum |
Data will be recorded baseline & fourth week |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
15/03/2024 |
| 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="0" Months="6" 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
|
AIMS AND OBJECTIVES To study the effect of resistance exercises on blood glucose level (HbA1C) in patients with type 2 Diabetes Mellitus coming to rural health setup To find out the effect of resistant exercises on blood glucose level HbA1C 10RM
SELECTION CRITERIA INCLUSION CRITERIA 1 Patients willing to participate 2 Patients diagnosed with type 2 DM with HbA1C≥ 6.4 3 BMI ≥ 23 kg/m2 4 Patient able to perform 10RM using weight cuff 5 Patients hand grade 3 in MMT
EXCLUSION CRITERIA 1 Elevated BP (resting BP> 200/115) 2 Cardiac disorders such as coronary artery disease, atrial fibrillation. 3 Respiratory disorders . 4 Patient not willing to participate 5 Orthopaedic Abnormalities
Exercise Protocol will be of 40 Minutes. Subjects will be undergoing the exercise session for 40 min for 3days per week for the period of 4 weeks. The exercise regimen will be consisted of 5mins warm up session which included brisk walking , curl ups, neck rotations and gentle stretching. 30 min intervention phase Upper limb and lower limb patterns was administered in standing, resistance was given through weight cuff (weights cuff were selected ranging from least resistance i.e 0.5 kg to 2kg.) based on 10 RM According To FITT Principle - F - 3days /week (alternate days alternate muscle group ) I- moderate intensity 40% to 60% of 10 RM T- 30 min T- weight cuff Upper Limb Muscles - 1. TRAPEZIUS 2.BICEPS 3.TRICEPS 4.PECTORALS MAJOR Lower Limb Muscles - 1. QUADRICEPS 2.HAMSTRINGS 3.CALF 4. GLUTEI COOL DOWN PHASE STRECHINGS FOR THE SAME MUSCLES WILL BE GIVEN
The Data collected will be analyzed by various statistical methods mean, median and test of significance, The data will be analyzed with IBM SPSS 25 for windows statistical software. For all statistical analyses, probability levels of P < 0.05 will be considered statistically significant
STUDY PERIOD 6 Months
AMENDMENT OF PROTOCOL No change in the study procedure shall be affected without the mutual agreement of investigator, physician and ethical committee
CONFIDENTIALITY The identity of patient generated in the study will be bounded in strict confidence. The remaining data will be available only to the investigator involved in the study and to the regulatory authorities. Break in the confidentiality is possible only after detail review by the investigator and with the permission of the ethical committee. Information will be disclosed to the concerned person/authority under special circumstances like severe unreported untoward reactions.
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