| CTRI Number |
CTRI/2026/02/104859 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [physiotherapy and pranayam] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To see the effects of Pedal Exercise and Sama Vritti pranayama on blood pressure, respiratory rate, pulse rate and Fatigue level in hemodialysis patient. |
|
Scientific Title of Study
|
EFFECTS OF PEDAL EXERCISE VERSUS SAMA VRITTI PRANAYAMA ON HEMODYNAMIC PARAMETERS AND FATIGUE LEVEL IN HEMODIALYSIS PATIENTS :AN 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 |
Vanshika Patel |
| Designation |
PG MPT 1st year student |
| Affiliation |
College of Physiotherapy, Sumandeep Vidyapeeth. |
| Address |
PG1 classroom, 2nd floor, Department of CardioRespiratory Disorders and Intensive Care, College of Physiotherapy, Sumandeep Vidyapeeth, Pipariya taluka, Waghodia, Vadodara, Gujarat, India, 391760
Vadodara
GUJARAT
391760
India |
| Phone |
8128749894 |
| Fax |
|
| Email |
vanshikapatel1902@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tejas R Chokshi |
| Designation |
Professor |
| Affiliation |
College of Physiotherapy, Sumandeep Vidyapeeth. |
| Address |
College of Physiotherapy, Sumandeep Vidyapeeth, Pipariya taluka, Waghodia, Vadodara, Gujarat, India, 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9909557689 |
| Fax |
|
| Email |
svdu.administrator@sumandeepvidyapeethdu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tejas R Chokshi |
| Designation |
Professor |
| Affiliation |
College of Physiotherapy, Sumandeep Vidyapeeth. |
| Address |
College of Physiotherapy, Sumandeep Vidyapeeth, Pipariya taluka, Waghodia, Vadodara, Gujarat, India, 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9909557689 |
| Fax |
|
| Email |
svdu.administrator@sumandeepvidyapeethdu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dialysis unit, Department of Nephrology, Dhiraj General Hospital, Sumandeep Vidyapeeth Deemed to be University, Waghodia, Vadodara, Gujarat, India, 391760 |
|
|
Primary Sponsor
|
| Name |
Vanshika Patel |
| Address |
PG1 classroom, 2nd floor, Department of Cardio-Respiratory Disorders and Intensive Care, College of Physiotherapy, Sumandeep Vidyapeeth, Pipariya taluka, Waghodia, Vadodara, Gujarat, India, 391760. |
| Type of Sponsor |
Other [self - funded] |
|
|
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 |
| Dr Vanshika Patel |
Dialysis Unit, Dhiraj General Hospital. |
Dialysis Unit, Department of nephrology, Dhiraj General Hospital, Sumandeep Vidyapeeth Deemed to be university campus, Waghodia, pipariya, Vadodara, Gujarat, India, 391760.
Vadodara
GUJARAT |
8128749894
vanshikapatel1902@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidhyapeeth Institutional Ethics Committee. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
pedal exercise and sama vritti pranayama. |
Group A including even number participants performs pedal exercise for 30 minutes in three phases warm up, conditioning and cool down phase and Group B including odd number participants performs sama vritti pranayama for 15 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
Gender – Male and Female.
Age – Adults 18-64 years.
Receiving hemodialysis twice/thrice a week.
Haemodynamically stable individuals. |
|
| ExclusionCriteria |
| Details |
Unstable cardiac conditions.
Severe dyspnea.
Lower-limb mobility limitations.
Cognitive impairment/ Dementia.
Acute infectious diseases. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fatigue Level( using Borge scale) |
pre to post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters( Blood pressure, Pulse rate and Respiratory rate) |
pre to post intervention |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
09/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
09/03/2026 |
| 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
|
Participants undergoing hemodialysis will be screened based on inclusion criteria, and written informed consent will be obtained from eligible and willing individuals.Participants will be randomly allocated into two groups: Group A (Pedal Exercise) and Group B (Sama Vritti Pranayama). Baseline assessment of fatigue (using the Borg Rating of Perceived Exertion Scale) and hemodynamic parameters (blood pressure, pulse rate, and respiratory rate) will be recorded before each intervention session.Interventions will be administered twice weekly for four weeks during the first two hours of hemodialysis.Group A will perform a 30-minute pedal exercise session consisting of warm-up, conditioning (cycling at 45–50 RPM), and cool-down phases. Vital parameters will be monitored during exercise, and the session will be discontinued if adverse symptoms occur.Group B will perform Sama Vritti Pranayama (equal ratio breathing: 4-4-4-4 seconds) for approximately 15 minutes, completing six cycles with rest intervals between cycles.Post-intervention fatigue and hemodynamic parameters will be recorded immediately after the session and every 2 minutes until values return to baseline. The same procedure will be followed in all sessions for both groups over the 4-week study period. |