| CTRI Number |
CTRI/2025/07/091193 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of aerobic exercise on chronic kidney disease |
|
Scientific Title of Study
|
Effect of moderate aerobic exercise with and without resistance on kidney function in chronic kidney disease. |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
G VENUVENDHAN |
| Designation |
Research Scholar |
| Affiliation |
Dr.MGR Educational and Research Institute |
| Address |
Faculty of physiotherapy, ACS Medical College and Hospital, Velappanchavadi
Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
8300502550 |
| Fax |
|
| Email |
venuvendhang@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
V. RAJALAXMI |
| Designation |
Vice Principal / professor |
| Affiliation |
Dr.MGR Educational and Research Institute |
| Address |
Faculty of Physiotherapy,
ACS Medical college and Hospital, Velappanchavadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9176123939 |
| Fax |
|
| Email |
rajalaxmigopalakrishnan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
G VENUVENDHAN |
| Designation |
Research Scholar |
| Affiliation |
Dr.MGR Educational and Research Institute |
| Address |
Faculty of Physiotherapy, ACS Medical college and Hospital, Velappanchavadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
8300502550 |
| Fax |
|
| Email |
venuvendhang@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Physiotherapy,
ACS Medical College and Hospital,
Dr. MGR Educational and Research Institute
Velappanchavadi, Chennai- 600077 |
|
|
Primary Sponsor
|
| Name |
G VENUVENDHAN |
| Address |
Faculty of Physiotherapy,
ACS Medical College and Hospital,
Dr. MGR Educational and Research Institute
Velappanchavadi, Chennai- 600077 |
| 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 |
| G VENU VENDHAN |
ACS Medical College and Hospital, Velappanchavadi, Chennai- 600077 |
department of physiotherapy,
Chennai
TAMIL NADU |
8300502550
venuvendhang@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| A.C.S Medical College Hospital |
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
|
| Type |
Name |
Details |
| Intervention |
Moderate aerobic exercise |
Moderate aerobic exercise for 30 mins |
| Intervention |
Moderate Aerobic exercise |
Moderate Aerobic exercise with resisted exercise for 30 mins |
| Comparator Agent |
standard CKD management |
no exercise is prescribed |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. CKD patients with stage 3 and 4 on eGFR
2. Chronic kidney disease with age ranges from
30 to 50 years
3.Both genders
4. Medical clearance for exercise |
|
| ExclusionCriteria |
| Details |
1. Severe chronic kidney disease – stage 5
2. CKD caused other than diabetes and hypertension
3. Age over and above 50 years
4. Mentally unstable patients
5. Recent myocardial Infraction
6. COPD and Asthma
7. Uncontrolled diabetic mellitus and hypertension
8. Any neurological conditions that restrict the
mobility of the individuals
9. Recent fracture within six months in lower
limb and upper limb
10. Severe OA knee, hip or ankle joint
11. Any type of carcinoma
12. Patient those who are physically active (doing moderate exercise) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Blood urea and creatine
2. Urine protein |
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. 6 minute walk test
2. Fatigue Severity Scale
3. Kidney Disease Quality of Life Short Form |
24 weeks |
|
|
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)
|
01/08/2025 |
| 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="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
|
Aim: Chronic renal disease is a serious condition that affects the kidney leds to various complications like high blood pressure, anemia, and general weakness and also effects the bones, nerves and heart. Aerobic exercise have various health benefit and prescribed for prevention and management of various diseases like diabetic mellitus, cardiovascular diseases, musculoskeletal problems, age related problems, cancer, etc. but the exercise prescription in the CKD patients are very minimal due the little understanding of the effect of exercise in this patients. Hence the aim of the study is to find effect aerobic exercises in renal functions of chronic renal disease. Objective: To find effect aerobic exercise in renal function of chronic kidney disease, functional capacity of CKD patients, fatigability level of CKD patients and Quality of life in CKD patients. Methodology: It’s an experimental design with comparative study ( pre and posttest ) in Out Patient Department of physiotherapy - ACS medical college and Hospitals, Study duration of 24 weeks. sample size of 35 / group ( total 105 for 3 groups) Subjects were Randomly assigned three groups. Group 1 - Moderate intensity Continues walking and resisted exercise, for minimum 30 min/ day for 5 days a week with the intensity 12 to 14 Borg rating of perceived exertion. Group 2 - Moderate intensity Continues walking for minimum 30 min / day for 5 days a week with Intensity 12 to 14 on Borg rating of perceived exertion Group 3 - Conventional where no specific exercise will be prescribed. Outcome: Outcome measures are blood urea and creatine, Urine protein, 6 minute walk test, Fatigue Severity Scale and Kidney Disease Quality of Life Short Form |