| CTRI Number |
CTRI/2024/04/065602 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| 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 Intradialytic Leg Ergometry Exercise in Patients with Chronic Kidney Disease |
|
Scientific Title of Study
|
Effect of Intradialytic Leg Ergometry Exercise on Muscle Strength, Fatigue, Sleep Quality and Kidney Function Test in Patients with Chronic Kidney Disease: A Randomised Controlled 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 |
Gauri Bhutada |
| Designation |
Pg Student |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Department of Cardio-Respiratory Physiotherapy, Ravi Nair Physiotherapy Collage, Datta Meghe Institute of Higher Education and Research(deemed to be university), Sawangi(meghe) Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7709436048 |
| Fax |
|
| Email |
gauribhu1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishnu Vardhan |
| Designation |
Professor |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Department of Cardio-Respiratory Physiotherapy, Ravi Nair Physiotherapy Collage, Datta Meghe Institute of Higher Education and Research(deemed to be university), Sawangi(meghe) Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8379917421 |
| Fax |
|
| Email |
Vishnu.vardhan@dmiher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishnu Vardhan |
| Designation |
Professor |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Department of Cardio-Respiratory Physiotherapy, Ravi Nair Physiotherapy Collage, Datta Meghe Institute of Higher Education and Research(deemed to be university), Sawangi(meghe) Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8379917421 |
| Fax |
|
| Email |
Vishnu.vardhan@dmiher.edu.in |
|
|
Source of Monetary or Material Support
|
| Ravi Nair Collage of Physiotherapy, Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research (deemed to be university), Sawangi Meghe Wardha 442107, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Ravi Nair Collage of Physiotherapy |
| Address |
Department of Cardiorespiratory Physiotherap, Ravi Nair Physiotherapy Collage, Datta Meghe Institute of Higher Education and Research [Deemed to be University], Sawangi(Meghe) Wardha |
| 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 |
| Dr Gauri Bhutada |
Acharya Vinoba Bhave Rural Hospital and Hemodialysis Centre |
Department of Cardiorespiratory Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (Deemed to be University) Sawangi Wardha, Maharashtra
Wardha
MAHARASHTRA |
7709436048
gauribhu1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E878||Other disorders of electrolyte andfluid balance, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional physiotherapy exercises |
conventional physiotherapy protocol will include, stretching of lower limb muscles with 10 sec hold and 2 -3 sec hold between each repetitions. Ankle toe movements, Heel slides,
Deep breathing exercises.
|
| Intervention |
Intradialytic leg ergometry exercises along with conventional physiotherapy |
Intradialytic leg ergometry is a simple exercise which will include static cycling for 2 times a week for 4 weeks, 30 minutes in each of first hour of hemodialysis along with conventional physiotherapy which will include, stretching of lower limb muscles with 10 sec hold and 2 -3 sec hold between each repetitions, Ankle toe movements, Heel slides, Deep breathing exercises
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients on hemodialysis more than 3 months, Patients of grade III-IV of chronic kidney disease (CKD),
Patients with ability understand and follow instructions.
|
|
| ExclusionCriteria |
| Details |
1.Musculoskeletal problems (rheumatoid arthritis, spondyloarthropathy, osteoarthritis of knee & hip, fracture hip, etc.)
2.Unstable vitals
3.Mentally unstable patients
4.Patients having any kind of infections
5.Un co-operative patients
6.Consistent hypotension on dialysis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Manual muscle test
2.Sleep quality- Pittsburgh Sleep Quality Index
3.Fatigue level- FACIT scale (Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale) |
baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| kidney function test |
baseline and after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| 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 Yet Recruiting |
| 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
|
The aim of our study is to find out the effect of intradialytic leg ergometry exercise on muscle strength, fatigue, sleep quality and kidney function test in patients with chronic kidney disease disease. Intradialytic leg ergometry exercise is a improves physical fitness. Chronic kidney disease is characterized by a gradual loss of kidney function over time. |