| CTRI Number |
CTRI/2024/11/077370 [Registered on: 26/11/2024] Trial Registered Prospectively |
| Last Modified On: |
20/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Connection between physical capability and performance in people with chronic venous conditions. |
|
Scientific Title of Study
|
Relationship between Functional Capacity and Performance Levels in Individuals with Chronic Venous Diseases. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepshikha Singh |
| Designation |
Post Graduate Student |
| Affiliation |
Ramaiah College Of Physiotherapy (RUAS) |
| Address |
Ramaiah College of Physiotherapy- RUAS,(department of physiotherapy) M S Ramaiah
Nagara, MSRIT Post, Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
7024727730 |
| Fax |
|
| Email |
deepshikhasingh.blooms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena Kiran Nambiar |
| Designation |
Professor |
| Affiliation |
Ramaiah College Of Physiotherapy (RUAS) |
| Address |
Ramaiah College of Physiotherapy- RUAS,(department of physiotherapy
M S Ramaiah
Nagara, MSRIT Post, Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9880575407 |
| Fax |
|
| Email |
veenakn.rcp@msruas.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena Kiran Nambiar |
| Designation |
Professor |
| Affiliation |
Ramaiah College Of Physiotherapy (RUAS) |
| Address |
Ramaiah College of Physiotherapy- RUAS,(department of physiotherapy
M S Ramaiah
Nagara, MSRIT Post, Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9880575407 |
| Fax |
|
| Email |
veenakn.rcp@msruas.ac.in |
|
|
Source of Monetary or Material Support
|
| Ramaiah College of Physiotherapy , M S Ramaiah Nagara ,MSRIT POST , Bangalore -560054
|
| Ramaiah medical and college hospital, M S Ramaiah Nagara ,MSRIT POST , Bangalore -560054
|
| Ramaiah memorial hospital , M S Ramaiah Nagara ,MSRIT POST , Bangalore -560054
|
|
|
Primary Sponsor
|
| Name |
Deepshikha Singh |
| Address |
Ramaiah College of Physiotherapy , M S Ramaiah Nagara , MSRIT POST , Bangalore -560054
|
| Type of Sponsor |
Other [SELF] |
|
|
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 Deepshikha Singh |
Ramaiah medical college and hospital |
Department of Physiotherapy M S Ramaiah nagara, MSRIT post, Bangalore-560054
Bangalore
KARNATAKA |
7024727730
deepshikhasingh.blooms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M S Ramaiah Medical College & Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I80-I89||Diseases of veins, lymphatic vessels and lymph nodes, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Individuals medically diagnosed with chronic venous disease according to clinical,
etiologic, anatomic, pathophysiologic classification CEAP stage 1 to 5.
Self ambulatory patient. |
|
| ExclusionCriteria |
| Details |
• Neurological conditions
• Metastatic conditions
• Peripheral arterial conditions.
• Psychological impairments
• Stage 6 (active ulcer )of CEAP classification |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
6 Minute Walk Test
30 Seconds Sit to Stand |
Baseline - one time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
06/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
06/12/2024 |
| 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 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
|
Functional capacity and performance levels are important indications of illness severity and progression in chronic venous diseases(CVD).. A decline in functional capacity often serves as an early indicator of deteriorating chronic venous disease or the onset of complications such as venous leg ulcers. Moreover, impairments in functional capacity and performance levels can lead to physical restrictions, psychological distress, and decreased social involvement, thereby reducing overall quality of life for those affected by CVD. Numerous studies have focused on managing clinical symptoms of chronic venous diseases, yet in India, the impact on performance level and functional capacity remains unexplored. Despite the high prevalence of these diseases in India, there is a notable gap in comprehending their functional implications. Therefore, there is a need for research to bridge this gap by elucidating the relationship between functional capacity and performance levels in individuals with chronic venous diseases. |