| CTRI Number |
CTRI/2024/08/071949 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
16/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Leg Ergometer and Chair Aerobics in subjects undergoing hemodialysis on Functional Capacity, Fatigue and Quality of life. |
|
Scientific Title of Study
|
Effectiveness of Leg Ergometer Vs Chair Aerobics in subjects undergoing hemodialysis on Hemodialytic Parameter Functional Capacity Fatigue and Quality of life A Randomized Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akshada kabnurkar |
| Designation |
PG student |
| Affiliation |
KLE Institute of Physiotherapy, nehru Nagar Belagavi |
| Address |
Advanced Physiotherapy Center,
Department of Cardiovascular And Pulmonary Physiotherapy
Room No. 6 Nehru Nagar, KLE DR Prabhakar Kore Hospital and Research Center Belagavi 590010 Karnataka
Advanced Physiotherapy Center,
Department of Cardiovascular And Pulmonary Physiotherapy
Room No. 6 Nehru Nagar, KLE DR Prabhakar Kore Hospital and Research Center Belagavi 590010 Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
8888631599 |
| Fax |
|
| Email |
akshadakabnurkar28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ganesh B.R |
| Designation |
Professor And Head Of Department of Cardio Vascular and Pulmonary Physiotherapy |
| Affiliation |
KLE Institute of Physiotherapy, nehru Nagar Belagavi |
| Address |
Advanced Physiotherapy Center,
Department of Cardiovascular And Pulmonary Physiotherapy
Room No. 6 Nehru Nagar, KLE DR Prabhakar Kore Hospital and Research Center Belagavi 590010 Karnataka
Advanced Physiotherapy Center,
Department of Cardiovascular And Pulmonary Physiotherapy
Room No. 6 Nehru Nagar, KLE DR Prabhakar Kore Hospital and Research Center Belagavi 590010 Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
8888631599 |
| Fax |
|
| Email |
ganeshbr@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Akshada kabnurkar |
| Designation |
PG student |
| Affiliation |
KLE Institute of Physiotherapy, nehru Nagar Belagavi |
| Address |
Advanced Physiotherapy Center,
Department of Cardiovascular And Pulmonary Physiotherapy
Room No. 6 Nehru Nagar, KLE DR Prabhakar Kore Hospital and Research Center Belagavi 590010 Karnataka
Advanced Physiotherapy Center,
Department of Cardiovascular And Pulmonary Physiotherapy
Room No. 6 Nehru Nagar, KLE DR Prabhakar Kore Hospital and Research Center Belagavi 590010 Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
8888631599 |
| Fax |
|
| Email |
akshadakabnurkar28@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr Prabhakar Kore Hospital and Research Centre Nehru Nagar Belagavi 590010 Karnataka India
|
|
|
Primary Sponsor
|
| Name |
Akshada Kabnurkar |
| Address |
KLE Institute of Physiotherapy, Nehru Nagar , Belagavi |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Akshada Kabnurkar |
KLE institute Of Physiotherapy |
Advanced Physiotherapy Center,
Department of Cardiovascular And Pulmonary Physiotherapy
Room No. 6 Nehru Nagar, KLE DR Prabhakar Kore Hospital and Research Center Belagavi 590010 Karnataka
Belgaum
KARNATAKA |
08888631599
akshadakabnurkar28@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and ethics comitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I998||Other disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
chair aerobics |
one group will be given leg ergometer and another one will be given chair aerobics in subjects undergoing hemodialysis
2 days/week for 6 weeks |
| Comparator Agent |
leg ergometer
|
one group will be given leg ergometer and another one will be given chair aerobics in subjects undergoing hemodialysis for 2 days/week for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects undergoing dialysis since 6 months at-least 2 times/week.
Subjects aged from 19-70 both male and female
Subjects diagnosed with CKD with End-stage Renal Disease.
Subjects who are willing to participate.
|
|
| ExclusionCriteria |
| Details |
Subject who are diagnosed with recent myocardial infarction, unstable angina, uncontrolled arrhythmia, acute stroke.
Hemodynamically unstable subjects.
Subjects with any mental illness which will hamper the patient condition.
Subject having disabilities of lower limb and upper limb.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
functional capacity - 6 minute walk test
fatigue index- borg scale
quality of life- kidney disease quality of life questionnaire |
baseline assessment and post intervention 6 week assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| hemodialytic parameters |
baseline assessment and post intervention 6 week assessment |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/08/2024 |
| Date of Study Completion (India) |
18/03/2025 |
| Date of First Enrollment (Global) |
26/08/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Individuals with chronic kidney disease often face challenges related to physical activity and exercise due to factors such as fatigue, muscle weakness, and potential complications like fluid and electrolyte imbalances so improving functional capacity can improve better QOL. The study will compare the effect of leg ergometers and chair aerobics since these 2 types of exercise have shown significant impact in improving functional capacity and fatigue index in various conditions. There is evidence of having low functional capacity and fatigue in subjects undergoing hemodialysis. There will be no difference in effect of leg ergometer and chair aerobics on, functional capacity, fatigue index, and quality of life in subjects undergoing hemodialysis. There will be effect of leg ergometer and chair aerobics on, functional capacity, fatigue index, and quality of life in subjects undergoing hemodialysis. |