| CTRI Number |
CTRI/2024/12/078324 [Registered on: 19/12/2024] Trial Registered Prospectively |
| Last Modified On: |
19/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Physiotherapy in patients with peripheral vascular disease |
|
Scientific Title of Study
|
Effectiveness of Prehabilitation on Quality of Life and Functional Impairment Measure in patients with Peripheral Vascular Disease following Physiotherapy. |
| 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 Jigar Mehta |
| Designation |
Professor |
| Affiliation |
K M Patel Institute of Physiotherapy |
| Address |
Shree Krishna Hospital, K M Patel Institute of Physiotherapy, Room no:152 Karamsad
Anand
Gujarat
388325
India
Anand
GUJARAT
388325
India |
| Phone |
9824771843 |
| Fax |
|
| Email |
jigarnm@charutarhealth.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jigar Mehta |
| Designation |
Professor |
| Affiliation |
K M Patel Institute of Physiotherapy |
| Address |
Shree Krishna Hospital, K M Patel Institute of Physiotherapy, Room no:152 Karamsad
Anand
Gujarat
388325
India
Shree Krishna Hospital, K M Patel Institute of Physiotherapy, Room no:152 Karamsad
Anand
GUJARAT
388325
India |
| Phone |
9824771843 |
| Fax |
|
| Email |
jigarnm@charutarhealth.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prachi Thakkar |
| Designation |
MPT Student |
| Affiliation |
K M Patel Institute of Physiotherapy |
| Address |
Shree Krishna Hospital, K M Patel Institute of Physiotherapy, Room no:152 Karamsad
Anand
Gujarat
388325
India
Anand
GUJARAT
388325
India |
| Phone |
9016005701 |
| Fax |
|
| Email |
prachivithlani1209@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Krishna Hospital, K M Patel Institute of Physiotherapy, Room no:152 Karamsad 388325 India |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Thakkar |
K M Patel Institute of Physiotherapy |
K M Patel Institute of Physiotherapy, Room No: 152, Karamsad, Anand, Gujarat, India 388325
Anand
GUJARAT
Anand
GUJARAT |
9016005701
prachivithlani1209@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Physiotherapy Exercise |
Physiotherapy exercise under supervision on follow up |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1- Diagnosed cases of peripheral vascular disease by vascular surgeon, planned for surgery
and referred for Physiotherapy.
|
|
| ExclusionCriteria |
| Details |
1- Serious co morbidities that affect the outcome measurements
2- Neurological and Musculoskeletal Disorders that affect Morbidity
3- Known cases of Psychiatric Disorders / Non cooperative patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Short Form-36 (SF-36) |
Before the intervention and at the end of intervention (3rd POD and 15th POD) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional Impairment Scale |
The Scale will be taken before & after the intervention (on admission, POD 3rd & 15th of intervention) |
|
|
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)
|
30/12/2024 |
| 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="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
|
INTRODUCTION : PVD is caused by a build-up of fatty deposits inside the walls of the arteries of the limbs, meaning less blood supply can get through. PVD Involves issues with the veins, such as chronic venous insufficiency or varicose veins. The treatment may include lifestyle changes to lower the risk of the disease this may include regular exercise and good nutrition. The VRP (Vascular Rehabilitation Program) is an essential and effective exercise program designed to ameliorate exercise tolerance and decrease the risk of progressive Cardiovascular Disease. Vascular rehabilitation programs aim to minimize the risk of mortality secondary to CVD and to limit the psychological and physiological stresses of PAD, and optimize cardiovascular function to achieve more functional quality of life. Exercise regimens under supervision are beneficial for intermittent claudication patients in managing their claudication symptoms. These closely monitored courses are an essential part of treatment to control symptoms of PAD and stop the condition from getting worse and requiring surgery
There is Dearth of Knowledge about Prehabilitation in Peripheral Vascular Disease patients. The majority articles are for Post Operative care, exercise or Prevention for it, therefore need of the study is targeting at Prehabilitation on the recovery can be measure with available exercises in them.
METHODOLOGY : The participants will be recruited as per the inclusion & exclusion criteria. Participants will be explained about the research purpose and procedure. Once participants agree to participate in study, written informed consent will be obtained. .Participants will be allocated randomly in two groups.
Group (A) Control Group - Only Rehabilitation program group Group (B) Experimental Group - Prehabilitation and Rehabilitation program
Both the outcome measures will be assessed pre and post surgery.
|