| CTRI Number |
CTRI/2026/01/101717 [Registered on: 21/01/2026] Trial Registered Prospectively |
| Last Modified On: |
20/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Aerobic Resistance and Inspiratory (ARIS) Training on functional
Capacity and Quality of Life in Patients With Chronic Kidney Disease Undergoing Dialysis:A Quasi-Experimental Study |
|
Scientific Title of Study
|
Effectiveness of Aerobic Resistance and Inspiratory (ARIS) Training on functional
Capacity and Quality of Life in Patients With Chronic Kidney Disease Undergoing Dialysis:A Quasi-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 |
Nisha Muthusamy |
| Designation |
PG RESIDENT |
| Affiliation |
KMCH COLLEGE OF PHYSIOTHERAPY |
| Address |
153/A
SAVADI STREET
R P PUDUR
NAMAKKAL
259 and 267
Kalapatti post
Coimbatore 641048
Coimbatore
TAMIL NADU
637001
India |
| Phone |
8526725318 |
| Fax |
|
| Email |
nishamuthu27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shanmugapriya M |
| Designation |
Assistant professor |
| Affiliation |
KMCH COLLEGE OF PHYSIOTHERAPY |
| Address |
259 and 267
Kalapatti post
Coimbatore 641048
259 and 267
Kalapatti post
Coimbatore 641048
Coimbatore
TAMIL NADU
641048
India |
| Phone |
7339370110 |
| Fax |
|
| Email |
shanmugapriya.m@kmchphysiotherapy.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Nisha Muthusamy |
| Designation |
Pg resident |
| Affiliation |
KMCH COLLEGE OF PHYSIOTHERAPY |
| Address |
153/A
Savadi street
R P Pudur
Namakkal
259 and 267
Kalapatti post
Coimbatore 641048
Coimbatore
TAMIL NADU
637001
India |
| Phone |
8526725318 |
| Fax |
|
| Email |
nishamuthu27@gmail.com |
|
|
Source of Monetary or Material Support
|
| KMCH COLLEGE OF PHYSIOTHERAPY 259 and 267
Kalapatti post
Coimbatore 641048 |
|
|
Primary Sponsor
|
| Name |
KMCH College of Physiotherapy |
| Address |
SF NO: 259 & 267 Kalapatti Post, Coimbatore -641048 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrMangala KumarV |
Kovai medical center and hospital |
Department of Nephrology, 2nd floor, 99A Avinashi road, coimbatore 641014
Coimbatore
TAMIL NADU |
8526725318
nishamuthu27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee KMCH institute of Allied Health Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aerobic exercise |
aerobic exercise - stationary cycling |
| Intervention |
ARIS( Aerobic resistance and inspiratory training) |
aerobic - stationary cycling
resistance - weight cuffs
inspiratory training - incentive spirometry all these exercises combined helps in improving functional capacity and quality of life in individuals |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
stage 4 and 5 of chronic kidney disease undergoing dialysis |
|
| ExclusionCriteria |
| Details |
uncontrolled hypertension
severe anemia
unstable cardiac condition
malignancy or history of malignancy
type 1 diabetes mellitus
subjects with peritoneal dialysis catheter
severe respiratory illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Functional capacity
|
Baseline and 8th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
Baseline and 8th week |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/02/2026 |
| 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="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
|
This study examines methods to improve the functional capacity and quality of life for people who undergo dialysis. CKD is a life-threatening one that needs dialysis until the kidney transplantation occurs. This may cause symptoms like fatigue, reduced physical activity, and poor quality of life. So, the aim of the study is to determine the effects of ARIS (aerobic, resistance, and inspiratory muscle) training in patients with CKD. |