| CTRI Number |
CTRI/2024/08/072694 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
19/07/2024 |
| 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
|
Improving Leg Health in PAD Patients: Effects of Supervised Exercise on Mobility and Blood Flow |
|
Scientific Title of Study
|
Screening of Individuals at risk for Peripheral Arterial Disease in lower extremity and influence of supervised exercise training on physical function and lower extremity vascularization. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhoomika Sawant |
| Designation |
PhD Scholar Assistant Professor |
| Affiliation |
MGM School of Physiotherapy,MGM Institute of Health Sciences, Navi Mumbai |
| Address |
MGM Department of Physiotherapy MGM Hospital Kamothe Plot no 1 and 2 Navi Mumbai Taluka Panvel Raigarh MAHARASHTRA 410209 India
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
bsawant@mgmsopnm.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajani Mullerpatan |
| Designation |
Professor Director MGM School of Physiotherapy MGM Institute of Health Sciences Navi Mumbai |
| Affiliation |
MGM School of Physiotherapy MGM Institute of Health Sciences Navi Mumbai |
| Address |
MGM Department of Physiotherapy MGM Hospital Kamothe Plot no 1 and 2 Navi Mumbai Taluka Panvel Raigarh MAHARASHTRA 410209 India
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
rajani.kanade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajani Mullerpatan |
| Designation |
Professor Director MGM School of Physiotherapy MGM Institute of Health Sciences Navi Mumbai |
| Affiliation |
MGM School of Physiotherapy MGM Institute of Health Sciences Navi Mumbai |
| Address |
MGM Department of Physiotherapy MGM Hospital Kamothe Plot no 1 and 2 Navi Mumbai Taluka Panvel Raigarh MAHARASHTRA 410209 India
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
rajani.kanade@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM School of Physiotherapy MGM Institute of Health Sciences Kamothe sector 1 campus Navi Mumbai
Raigarh
MAHARASHTRA
410209 India |
|
|
Primary Sponsor
|
| Name |
Bhoomika Sawant MGM School of Physiotherapy MGM Institute of Health Sciences |
| Address |
MGM Educational Campus Department of Physiotherapy MGM Hospital Kamothe Plot no 1
and 2 Navi Mumbai Taluka Panvel Raigarh MAHARASHTRA 410209
India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Bhoomika Sawant |
MGM Institute of Health Sciences MGM School of Physiotherapy |
Department of
Physiotherapy,
MGM Hospital
Kamothe Plot no 1 and
2 Navi Mumbai Taluka
Panvel Raigarh
MAHARASHTRA
Raigarh
MAHARASHTRA
Raigarh
MAHARASHTRA |
02227437866
bsawant@mgmsopnm.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Peripheral Arterial Disease |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional rehabilitation group |
For the Conventional rehabilitation group, assessment will be followed by 1st physiotherapy training session before the initiation of rehabilitation program. Physiotherapy training sessions will be conducted at a feasible site that is either at participants own environment or at various hospitals of MGM within Navi Mumbai for the participant.
Care-giver in detail will be explained about the individuals physical function limitations and about the importance of exercises. It will be ensured that the care-giver also understands the technique and do’s and don’ts of each and every exercise. So that he/she can assist and guard the elderly individual during exercises suggested and taught.
Each person will receive an individualized and comprehensive program including structured exercise, and behavioural and lifestyle modification. Smoking cessation is a vital component of care for patients with PAD who continue to smoke, and the full range of options including supportive counselling
|
| Intervention |
Experimental group |
For the experimental rehabilitation group, assessment will be followed by 1st physiotherapy training session before the initiation of the novel Supervised exercise training program. Physiotherapy training session will be conducted at a feasible site that is either at participants own environment or at various hospitals of MGM within Navi Mumbai for the participant. following initial assessment the participants will undergo a supervised exercise training protocol, which will be three days a week for 3 months. Post three months the patients will undergo post training assessment and longitudinal follow up will be taken however for the study it will be 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Males and females with risk factors Either Diabetes or Hypertension With one the following; Smoking, hypercholesteremia, physical Inactivity, Obesity .
ABI value 0.7-0.9(mild to moderate affection of Peripheral arterial disease.
|
|
| ExclusionCriteria |
| Details |
Dementia
Induvial with cognitive impairment – inability to follow instructions
Amputation
Major surgery or myocardial infraction
during previous three months
Unstable Angina
Walking limited by a condition other than leg Ischemia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
early identification of risk factors for Peripheral Arterial Disease
to understand lower limb vascularisation in ground level activities
to develop a supervised exercise training protocol for improving physical function and quality of life in patients with peripheral arterial diease
|
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Early identification of Peripheral Arterial Disease using a Novel screening tool |
screening tool |
|
|
Target Sample Size
|
Total Sample Size="484"
Sample Size from India="484"
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)
|
01/09/2024 |
| 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="3"
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 Peripheral arterial disease (PAD) is a circulatory condition resulting from reduced blood flow through the arteries, primarily due to atherosclerosis. PAD affects about 10-15% of the population and 20% of people over 60. Despite its prevalence, PAD is often underdiagnosed, especially in developing countries like India. PAD leads to significant physical and psychosocial impairments, increasing the risk of coronary heart disease, cerebrovascular disease, and severe limb complications. Research Question To investigate early screening for PAD and the impact of supervised exercise training on physical function, quality of life, and lower limb vascularisation. Clinical Significance Effective non-invasive screening tools for PAD are crucial, especially for asymptomatic patients, to improve prognosis. Physical activity can reduce the risk and improve survival in PAD patients. This study aims to develop a novel non-invasive screening tool and a supervised exercise training protocol to enhance physical function and vascularisation in PAD patients. Aim of the Study To screen individuals at risk for early signs of PAD in the lower extremities and evaluate the effect of exercise training on physical function, quality of life, and lower extremity vascularisation. Objectives - Identify early signs of lower extremity PAD in at-risk individuals (e.g., those with diabetes or hypertension).
- Study lower extremity vascularisation in activities such as squatting and kneeling in individuals with mild to moderate PAD.
- Compare the effect of a 12-week supervised exercise program on physical function, quality of life, and lower extremity vascularisation between a control group and an intervention group.
Conclusion This study aims to develop a novel non-invasive tool for early diagnosis of PAD and evaluate the benefits of a supervised exercise training protocol, aiming to improve physical function, quality of life, and vascular health in PAD patients |