| CTRI Number |
CTRI/2018/02/011706 [Registered on: 05/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
24/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of weekly activity level and the individuals capacity and their relationship with sleep disturbance in type 1 and type 2 diabetes patients |
|
Scientific Title of Study
|
An analytical study on physical activity, functional capacity ans sleep health in patients with type 1 and type 2 diabetes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VPrithiha |
| Designation |
MPT final year student |
| Affiliation |
Sri Ramachandra Medical College and Research Institute, College of physiotherapy |
| Address |
82A/1A, manimegalai street, umayalpuram, chrompet, Chennai
1, Ramachandra nagar, chennai 600116
Thiruvallur
TAMIL NADU
600 044
India |
| Phone |
7358351275 |
| Fax |
0 |
| Email |
prithihavenugopalan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
TSenthil kumar |
| Designation |
Assistant Professor, |
| Affiliation |
Sri Ramachandra Medical College and Research Institute (deemed to be university) |
| Address |
Sri Ramachandra Medical College and Research Institute(deemed to be university)
College of Physiotherapy
No-1,ramachandra nagar,porur Chennai- 116
1, Ramachandra nagar, chennai 600116
Thiruvallur
TAMIL NADU
600 116
India |
| Phone |
9444368189 |
| Fax |
0 |
| Email |
tsktill@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VPrithiha |
| Designation |
MPT final year student |
| Affiliation |
Sri Ramachandra Medical College and Research Institute (deemed to be university) |
| Address |
82A/1A, manimegalai street, umayalpuram, chrompet, Chennai
1, Ramachandra nagar, College of Physiotherapy, Sri ramachandra medical college and research institute ( deemed to be university)chennai 600116
Thiruvallur
TAMIL NADU
600 044
India |
| Phone |
7358351275 |
| Fax |
0 |
| Email |
prithihavenugopalan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Hospital,
Outpatient Diabetic clinic
No 1, Ramachandra nagar,porur,
Chennai-116 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 |
| V Prithiha |
Sri Ramachandra Hospital outpatient diabetic clinic |
no-1 ramachandra nagar, porur, chennai 116
Thiruvallur
TAMIL NADU |
7358351275
0
prithihavenugopalan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type 1 and type 2 diabetic patients, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Uncomplicated diabetic patients
1 year since diagnosed as diabetic |
|
| ExclusionCriteria |
| Details |
Complicated diabetic patients (sensory neuropathy)
Persons with clinically evident distal symmetrical neuropathy as symptoms and signs |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Physical activity level by GPAQ Questionnaire
Functional capacity by 6 minute walk test
|
One time evaluation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sleep inventory questionnaire |
Total score is 17 |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/09/2017 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
An observational study is planned to be conducted at the Diabetic Out Patient Department, Sri Ramachandra Hospital Chennai. An informed consent is obtained from the study population. By purposive sampling method, the type 1 and type 2 diabetes patients are administered with questionnaires (GPAQ and Sleep Inventory Questionnaire for the evaluation of physical activity level and sleep deprivation. Functional capacity is assessed by 6 minute walk test. The blood glucose level, HbA1c, details would be obtained from the case sheets and waist hip ratio is measured for further analysis |