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CTRI Number  CTRI/2025/07/089986 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 01/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Analytical 
Study Design  Other 
Public Title of Study   Relationship of physical activity and exercise confidence with quality of life in patients undergoing dialysis 
Scientific Title of Study   Association of physical activity and exercise self-efficacy with quality of life among patients undergoing dialysis: An analytical study 
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 Shreya Dhake 
Designation  HOD and Asso. Professor 
Affiliation  D.E.S. Brijlal Jindal college of Physiotherapy 
Address  Department of Cardiovascular and respiratory physiotherapy, DES Brijlal Jindal College of Physiotherapy, Fergusson College Campus, Shivajinagar,Pune

Pune
MAHARASHTRA
411004
India 
Phone  9892252731  
Fax    
Email  shreya.dhake@despune.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Chaitrali Bhide PT 
Designation  Post graduate student 
Affiliation  D.E.S. Brijlal Jindal college of Physiotherapy 
Address  DES Brijlal Jindal College of Physiotherapy, Fergusson College Campus, Shivajinagar,Pune

Pune
MAHARASHTRA
411004
India 
Phone  9370978733  
Fax    
Email  chaitrali.bhide733@deccansociety.org  
 
Details of Contact Person
Public Query  
Name  Dr Chaitrali Bhide PT 
Designation  Post graduate student 
Affiliation  D.E.S. Brijlal Jindal college of Physiotherapy 
Address  DES Brijlal Jindal College of Physiotherapy, Fergusson College Campus, Shivajinagar,Pune

Pune
MAHARASHTRA
411004
India 
Phone  9370978733  
Fax    
Email  chaitrali.bhide733@deccansociety.org  
 
Source of Monetary or Material Support  
D.E.S. Brijlal Jindal College of Physiotherapy, Fergusson , IndiaCollege Campus, Pune- 411004 
 
Primary Sponsor  
Name  Chaitrali Bhide 
Address  DE societys Brijlal Jindal College of Physiotherapy, Fergusson college campus,Pune-411004,Maharashtra 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
None  None 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Chaitrali Bhide  ANP Care Foundation  4th Floor, Royal Mystic, 28/2B, Colony, Shivraj Nagar, Rahatani, Pimpri-Chinchwad, Pune, Maharashtra 411017
Pune
MAHARASHTRA 		 9370978733

chaitrali.bhide733@deccansociety.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, DE societys Brijlal Jindal College of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E878||Other disorders of electrolyte andfluid balance, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Age group of 18-65 years
2)History of minimum 6 months of dialysis
3)Able to ambulate at least 50mts.
 
 
ExclusionCriteria 
Details  1)Dementia or severe cognitive impairment
2)Peripheral neuropathy, acute stroke or any other neurological conditions hampering ambulation.
3)Acute cardiac & pulmonary conditions which might interfere in ambulation E.g. Myocardial Infarction, Congestive Cardiac failure, Pulmonary embolism. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1]International Physical Activity Questionnaire – Short Form
2]Exercise Self-efficacy Scale (ESES)
3]Kidney Disease Quality of Life 36-Item Short Form Survey 		 All assessments were conducted at a single time point after completion of the patient’s routine dialysis session. 
 
Secondary Outcome  
Outcome  TimePoints 
None  None 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
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)   20/07/2025 
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   Chronic kidney disease (CKD) affects over 850 million people globally and could become the fifth leading cause of early death by 2040. Dialysis including haemodialysis and peritoneal dialysis, a widely used treatment for Stage 5 CKD. Patients undergoing dialysis often experience a significant decline in quality of life. Improving health-related quality of life (HRQoL) is a key goal in the treatment and rehabilitation of patients with chronic kidney disease (CKD). Research has shown that exercise training in dialysis patients reduces fatigue, decreases muscle cramps, and helps manage complications such as uremic nephropathy and myopathy. It also improves peripheral cardiovascular function, regulates blood pressure, enhances muscle blood flow, and increases physical work capacity. Despite these significant benefits, many patients undergoing dialysis remain inactive. Self-efficacy for physical exercise plays an important role in sustaining motivation and goal-directed behavior. It could be a key factor in enhancing quality of life by encouraging physical activity. This study aims to assess the relationship between physical activity, exercise self-efficacy and HRQoL in dialysis patients, emphasizing the importance of addressing psychological aspects in their care..
Participants will be included based upon inclusion and exclusion criteria. Basic demographic and clinical information, such as age, gender, duration of dialysis, and comorbidities, will be collected. Participants will complete the Exercise Self-Efficacy Scale and Kidney Disease Quality of Life 36-item short form survey to assess their exercise confidence and quality of life respectively. The questions will be asked in a language understood by the participants After collection of data, results will be drawn using statistical tools. 


 
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