| CTRI Number |
CTRI/2024/07/071145 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
survey |
| Study Design |
Other |
|
Public Title of Study
|
To understand benefits and difficulties of exercises in patients who underwent dialysis |
|
Scientific Title of Study
|
Perceived barriers and benefits of exercises in post dialysis patients- a survey. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Samyak Pagare |
| Designation |
Post graduate student |
| Affiliation |
DE societys Brijlal Jindal College of Physiotherapy, Pune |
| Address |
Department of Cardiovascular and respiratory physiotherapy, DE
societys Brijlal Jindal College of Physiotherapy, Fergusson college
campus, , FC road, Pune
Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
7038623339 |
| Fax |
|
| Email |
samyakpagare333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shreya Rahul Dhake PT |
| Designation |
HOD and Asso. Professor |
| Affiliation |
DE societys Brijlal Jindal College of Physiotherapy, Pune |
| Address |
Department of Cardiovascular and respiratory physiotherapy, DE
societys Brijlal Jindal College of Physiotherapy, Fergusson college
campus, FC road, Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
9892252731 |
| Fax |
|
| Email |
shreya.dhake@despune.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shreya Rahul Dhake PT |
| Designation |
HOD and Asso. Professor |
| Affiliation |
DE societys Brijlal Jindal College of Physiotherapy , Pune |
| Address |
Department of Cardiovascular and respiratory physiotherapy, DE
societys Brijlal Jindal College of Physiotherapy, Fergusson college
campus, FC road, Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
9892252731 |
| Fax |
|
| Email |
shreya.dhake@despune.org |
|
|
Source of Monetary or Material Support
|
| DES society college of physiotherapy fergusson college campus ,FC road ,pune. |
|
|
Primary Sponsor
|
| Name |
Samyak Pagare |
| Address |
department of cardiovascular and respiratory physiotherapy DES Brijlal jindalcollege of physiotherapy Fergusson College Campus, Pune 411 004, Shivajinagar, Maharashtra |
| 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 |
| Samyak Pagare |
DES brijlal jindal college of physiotherapy |
DES brijlal jindal college of physiotherapy ,cardiovascular and respiratory department of physiotherapy on ground floor
Pune, 411004
MAHARASHTRA
Pune
MAHARASHTRA |
7038623339
samyakpagare333@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, DE societys Brijlal Jindal College of Physiotherapy, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 35-65 years.
2. Both males and females.
3. Patients with Chronic kidney disease stage
3,4 undergoing Hemodialysis.
|
|
| ExclusionCriteria |
| Details |
1. Patients with impaired cognitive function
2. Patients undergoing peritoneal diagnosis
3. Unconscious patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dialysis patient-perceived Exercise Benefits and Barriers Scale |
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dialysis patient-perceived Exercise Benefits & Barriers Scale |
1day |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/08/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Chronic
diseases are the main challenges in health systems that impose enormous
healthcare costs for societies and governments. Chronic kidney diseases (CKD),
is considered a major health problem worldwide. An irreversible decrease in
kidney function among patients with CKD ultimately progresses them to end stage
kidney disease (ESKD) .There are about 3,730,000patients with CKD worldwide and
annual growth of this disease is 5-6%.Individuals
undergoing dialysis are considerably less physically active as compared to
individuals with milder stages of kidney disease. While there is a need for promoting physical activity and
exercise participation in dialysis patients, which is widely recognized in international and
national guidelines. Thus understanding individual-level barriers and benefits
may help increase participation in exercises. There is increasing prevalence of chronic kidney
disease in India. Literature shows that 129 per million undergoes dialysis,
with frequency of dialysis being two or three times per week.There is a taboo about exercises to be performed in
patients undergoing dialysis .Patients are unaware about exercises which can be
performed during this period. Evidence shows CKD patients are bound to develop
“Inactivity triad†which consists of Exercise deficit disorder, Physical
illiteracy & sarcopenia.The exercise not only reduces the complications of hemodialysis but also decreases the mortality rate of these patients and improves cardiovascular function, blood pressure, muscle strength, nutritional status, and dialysis quality. Inspite of all this positive benefits of exercises, patientswih dialysis
hardly enagage themselves in exercises.To bring change in them ,first we need to understand what are the
barriers with respect to exercises and also to understand perceived benefits of
exercises. |