| CTRI Number |
CTRI/2020/09/027539 [Registered on: 02/09/2020] Trial Registered Prospectively |
| Last Modified On: |
29/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of strengthening and stretching exercise on blood glucose level in type 2 diabetes patients |
|
Scientific Title of Study
|
Effect of Proprioceptive Neuromuscular facilitation on blood glucose level and quality of life among type 2 diabetes mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
shagun agarwal |
| Designation |
Research scholar |
| Affiliation |
amity institute of physiotherapy |
| Address |
Amity university
sec 125
gautam budh nagar
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9910259583 |
| Fax |
|
| Email |
shagunbpt@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
JASOBANTA SETHI |
| Designation |
DIRECTOR |
| Affiliation |
amity institute of physiotherapy |
| Address |
amity university
sec 125
gautam budh nagar
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9988600462 |
| Fax |
|
| Email |
jsethi@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
shagun agarwal |
| Designation |
Research scholar |
| Affiliation |
amity institute of physiotherapy |
| Address |
amity university
sec 125
gautam budh nagar
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9910259583 |
| Fax |
|
| Email |
shagunbpt@yahoo.com |
|
|
Source of Monetary or Material Support
|
| AMITY UNIVERSITY
GAUTAMBUDH NAGAR |
|
|
Primary Sponsor
|
| Name |
amity institute |
| Address |
amity institute of physiotherapy
sec125 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| shagun agarwal |
amity university |
sec125 , gautam budh nagar
Gautam Buddha Nagar
UTTAR PRADESH |
9910259583
shagunbpt@yahoo.com |
| shagun agarwal |
IAMR |
9mile stone , delhi meerut road duhai ghaziabad
Ghaziabad
UTTAR PRADESH |
9910259583
shagunbpt@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| amity university |
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 |
| Intervention |
proprioceptive neuromuscular strengthening |
Strengthening with theraband in PNF patterns using slow reversal hold
10 reps x 3 sets
UE patterns in standing
LE patterns in standing
Theraband would be selected from least resistance (yellow) to more (black) based on 10RM
10RM would be checked after 2 weeks
3 times /week for 12 weeks
PATTERNS OF UPPER LIMB AND LOWER LIMB
D1Flexion
D2Flexion
D1Extension
D2Extension
TRUNK LT /RT ROTATION
Walk as per control group
DIET PLAN
|
| Intervention |
proprioceptive neuromuscular stretching |
Slow Reversal Hold-relax method will be used
Hold for 10 sec and relax for 10 sec
Repetition 4 times
3 times /week for 12 weeks
PATTERNS OF UPPER LIMB AND LOWER LIMB
D1Flexion
D2Flexion
D1Extension
D2Extension
--TRUNK LT /RT ROTATION
Walk as per control group
DIET PLAN |
| Comparator Agent |
walking |
Type of exercise :prolonged , rhythmic activities using large muscle groups(e.g walking )
Duration : 150 min/week .
Frequency :5-7 days /week with no more than two days without exercise
Diet chart
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with T2DM diagnosed by clinician
Sedentary life style (Not involved in active sports , gym, yoga, before 6 months from study)
Age group 35-55(both male and female )
HbA1c level above 6.5
Ready to adherent to diet chart |
|
| ExclusionCriteria |
| Details |
Any other neurological disorder
Recent musculoskeletal injury
Involved in active sports
Current insulin therapy
Changes during the previous three months in:
Oral hypoglycemic medication
Anti hypertensive medication
Lipid lowering medication
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Blood glucose level
HbA1C
2.Average plasma glucose
3.Quality of life
Tool: Quality of life instrument for Indian diabetes patients (QOLID)
|
12 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| quality of life |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="399"
Sample Size from India="399"
Final Enrollment numbers achieved (Total)= "460"
Final Enrollment numbers achieved (India)="460" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/09/2020 |
| Date of Study Completion (India) |
20/08/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Effect of proprioceptive neuromuscular facilitation stretching versus aerobic training on glycosylated hemoglobin (HbA1C) in patients with type 2 diabetes mellitus
Shagun Agarwal, Jasobanta Sethi, Rajeev Aggrawal
Amity institute of Physiotherapy, Amity University Uttar Pradesh, Noida, India
Effect of proprioceptive neuromuscular facilitation strengthening versus proprioceptive neuromuscular facilitation stretching on glycosylated haemoglobin in patients with type 2 diabetes mellitus
Shagun Agarwal, Jasobanta Sethi, Rajeev Aggrawal
Amity institute of Physiotherapy, Amity University Uttar Pradesh, Noida, India |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Type 2 diabetes mellitus is a chronic disease characterized by decrease insulin sensitivity and overall poor glucose tolerance .Diabetes is fast gaining the status of a potential epidemic in INDIA with more than 72 million diabetic individuals currently diagnosed with the disease ,figure expected to almost double to 134 million by 2025. the annual cost to treat diabetes is estimated to be rs 27400 per capita, which if constant would reach an annual 1.95 lac crore by 2025. American diabetes association says that adoption and maintenance of physical activity are critical for blood glucose management and overall health in individuals with diabetes . few explorations has been established in the field of strengthening and stretching effectiveness on blood glucose levels among patient with type 2 diabetes. This study will give an insight to clinicians and patient community about the low cost therapeutic in blood glucose regulation among patients with type 2 diabetes mellitus . This experimental study has been designed to see the long term effectiveness of proprioceptive neuromuscular facilitation strengthening and proprioceptive neuromuscular facilitation stretching on HbA1c and quality of life in patient with type 2 diabetes mellitus .the study protocol is of 12 weeks so that we can see the long term effect of protocol. This study will give low cost exercise tool to patients . |