| CTRI Number |
CTRI/2024/03/064409 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Effect of nurse initiated rehabilitation program in improving circulation to the peripheral parts of the body to meet the needs of different tissues among patients with peripheral occlusive vascular disease. |
|
Scientific Title of Study
|
Effect of nurse-led rehabilitation program on peripheral circulation among patients with peripheral vascular disease. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jjothi M |
| Designation |
Professor |
| Affiliation |
Bishop Benziger College Of Nursing |
| Address |
Medical Surgical Nursing Department, Vellappally Natesan Shashtyabdapoorthi Smaraka College Of Nursing, S.N Trusts Medical Mission,KOLLAM.
Research Scholar
Bishop Benziger College of Nursing
Kollam,Kerala, 691001
Kollam
KERALA
691001
India |
| Phone |
9846089707 |
| Fax |
0474-2761801 |
| Email |
dev.dersan22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Anoopa K.R |
| Designation |
Principal |
| Affiliation |
Bishop Benziger College Of Nursing |
| Address |
Bishop Benziger College Of Nursing
Sastri Junction,Kollam
SIMET College Of Nursing,
Konny
Pathanamthitta,Kerala
Pathanamthitta
KERALA
691001
India |
| Phone |
8281302895 |
| Fax |
0474-2761801 |
| Email |
anoopasuresh@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr .Anoopa KR |
| Designation |
Principal |
| Affiliation |
Bishop Benziger College Of Nursing |
| Address |
Bishop Benziger College Of Nursing
SastriJunction
Kollam
SIMET College Of Nursing
Konny
Pathanamthitta
Kerala
Kollam
KERALA
691001
India |
| Phone |
8281302895 |
| Fax |
0474-2761801 |
| Email |
anoopasuresh@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Bishop Benziger Hospital,Kollam District |
| Holy Cross Hospital Kottiyam
Kollam District |
|
|
Primary Sponsor
|
| Name |
Jyothi.M |
| Address |
Sunil Bhavan,Pavithreswaram PO,Puthhor, Kollam,PIN:691507 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| JYOTHI M |
Selected hospitals of Kollam district |
Holy Cross Hospital ,Kottiyam
Kollam
KERALA |
9846089707
dev.dersan22@gmail.com |
| JYOTHI M |
Selected hospitals of Kollam district |
Bishop Benziger Hospital
Kollam
KERALA |
9846089707
dev.dersan22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Bishop Benziger Hospital |
Not Applicable |
| Holy Cross HOSPITAL,Kottiyam,Kollam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I739||Peripheral vascular disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse led rehabilitation program |
Pre test will be conducted on the day of admission by assessing demographic data, ankle brachial index, capillary refill time, pain free walking time and severity of claudication. Nurse led rehabilitation program includes structured exercise program and therapeutic education. Structured exercise program consist of supervised walking, buergers exercise, assisted standing calf raises, step up exercise and chair leg raises. After this therapeutic education will be provided , reference booklet also will be provided. The total duration of intervention is 1 hour 10minutes.The post test will be conducted on 3rd week,6th week and 12th week. |
| Comparator Agent |
Routine care |
Routine care as per hospital policy.Rehabilitation booklet will be provided on discharge. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
-Admitted with diagnosis of peripheral vascular disease and able to follow instructions.
-Able to speak and understand Malayalam.
-Admitted in the hospital for a minimum of three days. |
|
| ExclusionCriteria |
| Details |
-Major cardiac problems such as myocardial infarction in the last 6 months, unstable angina and uncontrolled cardiac arrhythmias
-Severe osteoarthritis, neuro paralytic disease
-Critical limb ischemia and waiting for/underwent surgery
-Mentally challenged patients. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| -Comparing outcome of ankle brachial index, capillary refill time, pain free walking time and severity of claudication among experimental and control group |
3 week, 6 weeks ,12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in the frequency of hospital visit after the administration of rehabilitation program. |
3 weeks,6 weeks ,12 weeks |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
27/03/2024 |
| 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 - YES
- What data in particular will be shared?
Response (Others) - nil
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response (Others) - nil
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response (Others) - nil
- By what mechanism will data be made available?
Response (Others) - nil
- For how long will this data be available start date provided 12-08-2024 and end date provided 12-12-2030?
Response (Others) - nil
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
The primary objective of the study is to evaluate the effect of Nurse - led rehabilitation program on peripheral circulation circulation among patients with peripheral vascular disease by comparing the effect of ankle brachial index ,capillary refill time, pain free walking time and severity of claudication. .The sample allocated for the study is cosequtive selection sample and allocating with block randomization. Descriptive and inferential statistics will be used for analysis. |