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CTRI Number  CTRI/2026/03/106202 [Registered on: 13/03/2026] Trial Registered Prospectively
Last Modified On: 13/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To find out if exercises during dialysis can reduce tiredness in people receiving dialysis treatment 
Scientific Title of Study   Effect of aerobic exercises on intradialytic exercises in subjects undergoing haemodialysis: A pilot experimental 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  SRIPADA KAMESWARI GAYATRI 
Designation  Student  
Affiliation  Gitam Institute Of Medical Sciences And Research, Gitam School Of Physiotherapy. 
Address  GITAM School of Physiotherapy, 4th floor Medical College Building, GIMSR Campus, GITAM (Deemed to be University), Rushikonda 530045, Visakhapatnam, Andhra Pradesh.

Visakhapatnam
ANDHRA PRADESH
530045
India 
Phone  9553580032  
Fax    
Email  ksripada2@gitam.in  
 
Details of Contact Person
Scientific Query  
Name  Dr. Aparna Pattnaik 
Designation  Assistant Professor  
Affiliation  Assistant Professor, GITAM Institute Of Medical Sciences And Research, Gitam School Of Physiotherapy. 
Address  GITAM School of Physiotherapy, 4th floor Medical College Building, GIMSR Campus, GITAM (Deemed to be University), Rushikonda 530045, Visakhapatnam, Andhra Pradesh.

Visakhapatnam
ANDHRA PRADESH
530045
India 
Phone  8240665569  
Fax    
Email  apattnai@gitam.edu  
 
Details of Contact Person
Public Query  
Name  SRIPADA KAMESWARI GAYATRI 
Designation  Student  
Affiliation  Gitam Institute Of Medical Sciences And Research, Gitam School Of Physiotherapy. 
Address  GITAM School of Physiotherapy, 4th floor Medical College Building, GIMSR Campus, GITAM (Deemed to be University), Rushikonda 530045, Visakhapatnam, Andhra Pradesh.


ANDHRA PRADESH
530045
India 
Phone  9553580032  
Fax    
Email  ksripada2@gitam.in  
 
Source of Monetary or Material Support  
GITAM School Of Physiotherapy, GITAM Institute Of Medical Sciences and Research  
 
Primary Sponsor  
Name  GITAM School Of Physiotherapy GITAM Institute Of Medical Sciences and Research 
Address  GITAM School of Physiotherapy, 4th floor Medical College Building, GIMSR Campus, GITAM (Deemed to be University), Rushikonda 530045,  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aparna Pattnaik PT  GITAM Institute of medical sciences and research   Department of Physiotherapy, OPD 1, Rushikonda, Endada, Andhra Pradesh 530045
Visakhapatnam
ANDHRA PRADESH 		 8240665569

apattnai@gitam.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GIMSR Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N189||Chronic kidney disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A  Participants in the intervention group will perform intradialytic pedal ergometer exercise during the second hour of the dialysis session. Each session will include a 5-minute warm-up consisting of stretching and squeeze ball exercises, followed by 30 minutes of moderately paced cycling on a pedal ergometer, and a 5-minute cool-down using the same conventional exercises. The intervention will be conducted three times per week for eight weeks. 
Comparator Agent  Group B   The control group will receive conventional care, including warm-up and cool-down exercises, without intradialytic cycling. 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Participants should be aged between 35 to 70 years.
The patients who are undergoing haemodialysis for atleast one year
Patients who are prescribed haemodialysis 3 times a week.
Patients with no history of cardiac problems like Myocardial infarction
Referral from nephrologist
Patients who give their consent 
 
ExclusionCriteria 
Details  Patients with limb anomalies
Patients aged above 70years
Uncontrollable hypertension (more than 150mmHg systole and 100mmhg diastole)
Hypotensive patients (less than 90mmHg systole and 60mmHg diastole)
Recent stroke
Any neurological or orthopedic conditions preventing them from exercises
Arteriovenous fistula
Patients on peritoneal dialysis
Patients who did not give their consent 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare pre- and post-intervention fatigue scores (FSS)  Once a week for 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To compare pre- and post Quality of life (KDQoL-36) and Physical performance (SPPB) between the intervention and control groups.  KDQol will be measured once every 2 weeks for 8 weeks and SPPB will be measured on 1st week, 4th week and 8th week.  
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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)   25/03/2026 
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="0"
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  

This pilot randomized controlled trial aims to evaluate the effect of intradialytic aerobic exercise using a pedal ergometer on fatigue among patients undergoing maintenance haemodialysis. A total of 32 participants (aged between 35 to 70 years) receiving haemodialysis three times per week for at least one year will be randomly allocated into intervention (ni=16) and control (nc=16) groups at the dialysis unit of GIMSR Hospital, GITAM University. The intervention group will perform supervised pedal ergometer exercise during dialysis for 40 minutes per session, three times per week for 8 weeks, while the control group will receive routine care. Outcomes including fatigue (Fatigue Severity Scale), kidney disease quality of life questionnaire (KDQoL-36) and short physical performance battery  (SPPB) will be assessed pre- and post-intervention. The study involves minimal risk, ensures informed consent, confidentiality, and continuous monitoring during exercise, and aims to determine whether structured intradialytic aerobic exercise can significantly reduce fatigue and improve functional outcomes and quality of life in haemodialysis patients.

 
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