| CTRI Number |
CTRI/2025/02/080505 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between nerve and muscle functions with fatigue in people with Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
Association of neuromuscular functions with fatigue in people 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 |
Dr Majumi M Noohu |
| Designation |
Professor |
| Affiliation |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi |
| Address |
Room Number 105, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Okhla, New Delhi
South
DELHI
110025
India |
| Phone |
9868023378 |
| Fax |
|
| Email |
mnoohu@jmi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Majumi M Noohu |
| Designation |
Professor |
| Affiliation |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi |
| Address |
Room Number 105, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Okhla, New Delhi
South
DELHI
110025
India |
| Phone |
9868023378 |
| Fax |
|
| Email |
mnoohu@jmi.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Tabbashum Khatun |
| Designation |
Postgraduate Student |
| Affiliation |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Okhla, New Delhi
South
DELHI
110025
India |
| Phone |
8105857836 |
| Fax |
|
| Email |
tabbashum.physio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Jamia Nagar Okhla, New Delhi-110025 |
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Jamia Nagar, Okhla, New Delhi, India, 110025 |
| Type of Sponsor |
Other [Central University ] |
|
|
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 Majumi M Noohu |
Centre for Physiotherapy and Rehabilitation Sciences Clinic, Jamia Millia Islamia, New Delhi |
Physiotherapy OPD, Room Number 08, Ground floor, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Okhla, New Delhi- 110025
South
DELHI |
9868023378
mnoohu@jmi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Institutional Ethical Committee, Jamia Millia Islamia, Jamia Nagar, New Delhi-110025 |
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 |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adults diagnosed with Type 2 Diabetes Mellitus more than or equal to 6 months
Male and female
Age between 40-70 years |
|
| ExclusionCriteria |
| Details |
Diabetic foot ulcer
Lower limb amputation
wheelchair bound
Over 70 years
Known history of stroke, cancer or other central nervous system pathology which may cause additional burden of fatigue besides diabetes
Inability to ambulate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Predicted variable:
Fatigue: will be assessed Multidimensional Fatigue Inventory
Predictor variables:
1. Muscle strength: Handheld dynamometer reading of knee extensors, ankle dorsiflexors.
Leg press test: to assess 1 Repetition Maximum determination
2. Muscle endurance: 2 minutes step test to assess muscle endurance
3. Nerve function: Nerve conduction velocity of Deep peroneal (Motor) and Sural nerve (sensory)
4. Sensory function: Monofilament test and Vibration Perception Threshold
5. Physical activity: International Physical Activity Questionnaire- Short form to assess Physical activity
6. Depression: Hamilton Depression Rating Scale to assess depression.
7. Quality of life : will be assessed using SF12-V2 questionnaire.
8. Functional status: International Classification of Functioning Disability and Health to assess the function status. |
Baseline assessment will be taken |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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)
|
15/01/2027 |
| 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="4"
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
|
Background: Fatigue is a prevalent and debilitating symptom in individuals with type 2 diabetes mellitus (T2DM), often impacting physical activity, psychological well-being, and overall quality of life. Neuromuscular function and other factors such as depression and functional capacity may play significant roles in its manifestation.
Aims: 1. To study the association of neuromuscular function with fatigue in individuals with T2DM. 2. To investigate the relationship between physical activity, depression, quality of life, and fatigue in this population. 3. To classify individuals into different fatigue levels and analyze their functional capacity.
Methodology It is a observational cross sectional study.
Predicted variable: Fatigue: Multidimensional Fatigue Inventory will assess fatigue
Predictor variables: 1.Muscle strength: Handheld dynamometer reading of knee extensors, ankle dorsiflexors and handgrip to assess muscle strength. Leg press testing: For 1 Repetition Maximum determination
2. Muscle endurance: 2 minutes step test to assess muscle endurance
3. Nerve function: Nerve conduction velocity of Deep peroneal (Motor) and Sural nerve (sensory)
4. Sensory function: Monofilament test and Vibration Perception Threshold
5. Physical activity: International Physical Activity Questionnaire- Short form to assess Physical activity
6. Depression: Hamilton Depression Rating Scale to assess depression.
7. Quality of life : will be assessed using SF12-V2 questionnaire.
8. Functional status: International Classification of Functioning Disability and Health to assess the function status.
Results: will be reported for all variables at baseline.
Significance: This study aims to identify key factors influencing fatigue in T2DM and provide a foundation for tailored intervention strategies to enhance patient outcomes and quality of life
|