| CTRI Number |
CTRI/2025/10/095932 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
10/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To compare effects of strengthening exercise during dialysis, and routine exercises to improve muscle strength and bone health in patients with chronic kidney disease |
|
Scientific Title of Study
|
A study to compare the effect of Intradialytic therapy, Progressive resisted exercises and Conventional exercises on muscle strength, markers of bone mineral metabolism and quality of life in patients with chronic kidney disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K .Baby Carolin |
| Designation |
Research Scholor |
| Affiliation |
Dr.MGR Educational and Research Institute |
| Address |
Faculty of Physiotherapy
ACS Medical college,
Velappanchavadi
Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9655019633 |
| Fax |
|
| Email |
kbabycarolin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Rajalaxmi |
| Designation |
Professor |Vice Prinvipal |
| Affiliation |
Dr.MGR Educational and Research Institute |
| Address |
Faculty of Physiotherapy
ACS Medical college
Velappanchavadi
Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9176123939 |
| Fax |
|
| Email |
rajalaxmiphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
K .Baby Carolin |
| Designation |
Research Scholor |
| Affiliation |
Dr.MGR Educational and Research Institute |
| Address |
Faculty of Physiotherapy
ACS Medical college
Velappanchavadi
Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9176123939 |
| Fax |
|
| Email |
kbabycarolin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Physiotherapy
ACS Medical college
Velappanchavadi
Chennai 600077 |
|
|
Primary Sponsor
|
| Name |
KBaby Carolin |
| Address |
Research scholor,Faculty of Physiotherapy
ACS Medical college,
Velappanchavadi,
Chennai. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| KBaby Carolin |
ACS Medical College &Hospital,Velappanchadi,Chennai,600077 |
Department of Nephrology
Chennai
TAMIL NADU |
9655019633
kbabycarolin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMITEE |
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 |
conventional exercises |
patient receives usual dialysis care with conventional exercises includes flexibility and stretching exercises .
|
| Intervention |
intradialytic therapy |
Patient receives Intradialytic exercise 3 times per week for 24 weeks
Exercise during the first 2 hours of Hemodialysis for 30 minutes
shoulder press, side shoulder raise, triceps extension, biceps curl, and external shoulder rotation for upper extremity strengthening.
seated knee extension, supine hip flexion, supine hip abduction, supine straight-legged raise, and seated leg curl for lower extremity strengthening; and bilateral straight-leg raises in a supine position or bilateral leg lifts in a seated position for abdominal strengthening.
|
| Intervention |
progressive resisted exercises |
Patients perform progressive resisted exercises during dialysis session targets both endurance and muscle strength potentially affecting bone health more.
The intervention groups performed exercise training during the first 2 hours of hemodialysis sessions using free leg weights.
exercises were resisted by weights, with 40–50% of the 1RM load .
The 1RM load was evaluated every 2 weeks and adjusted for each patient. The training program consisted of
3 groups of 15 repetitions in every lower limb with a 1-minute rest between the groups and a 2-minute rest between the exercise types, 3 times per week for 12 weeks.
upper extremity strengthening with progressive resistance training (PRT) with free-weight dumbbells, lower extremity strengthening with weighted ankle cuffs about 1 and progress to 2 kilograms.
Patients receives exercise for 12 weeks ,three times per week.
Progression based on strength and tolerance level.
|
|
|
Inclusion Criteria
|
| Age From |
34.00 Day(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
On maintenance Hemodialysis 3 sessions/week for at least 6 months.
No history of Myocardial Infarction for past 3 months.
Fit for functional assessment by incremental shuttle walk(ISWT) test. patient should meet 600 meters distance.
Patients with CKD stage
Patients with self reported physical inactivity.
Non wheelchair bound.
Able to provide informed consent.
|
|
| ExclusionCriteria |
| Details |
Patients with Malignancy
Patients with CKD stage 1 and 2
Severe musculoskeletal or neurological disorders.
Uncontrolled hypertension or arrhythmias.
Medications that could interfere with bone metabolism.
Active bone disease not related to chronic kidney disease/metabolic bone disease.
Patients with peritoneal dialysis
Lower limb disabilities/Amputation.
Deep Vein Thrombosis.
Femoral fistula.
use of medications that might influence PTH, calcium, or phosphorus levels
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the muscle strength
Upper and lower limb
2.To assess the bone mineral metabolism:
|
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the Anxiety and depression
To assess the quality of life
|
24 weeks |
|
|
Target Sample Size
|
Total Sample Size="99"
Sample Size from India="99"
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)
|
25/10/2025 |
| 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
|
Chronic kidney disease (CKD) is a progressive condition
where patients often require long-term hemodialysis. Individuals on maintenance
hemodialysis frequently experience muscle weakness, bone mineral imbalance, and
poor quality of life due to reduced physical activity and treatment-related
complications. Exercise interventions have been shown to improve strength,
functional capacity, and well-being in patients with CKD, but there is limited
evidence comparing different forms of exercise in this population.
The purpose of this study is to compare the effects of three different exercise
interventions on patients undergoing maintenance hemodialysis: (1)
intradialytic exercise performed during dialysis sessions, (2) progressive
resisted exercises conducted outside of dialysis, and (3) conventional
exercises. The study will evaluate changes in muscle strength, bone mineral
metabolism, and quality of life in these groups.
This will be a randomized controlled trial conducted among patients with CKD
undergoing regular hemodialysis. Eligible participants will be randomly
assigned to one of the three groups. Standardized protocols for each exercise
type will be followed under supervision. Outcome measures will include
assessment of muscle strength, biochemical markers of bone mineral metabolism,
and validated quality of life questionnaires.
It is expected that the findings of this study will provide evidence on the
most effective exercise strategy for improving physical health, bone status,
and overall quality of life in patients with CKD on hemodialysis. This may help
in developing exercise-based rehabilitation protocols as a part of routine
dialysis care. |