| CTRI Number |
CTRI/2024/11/077307 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
22/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Inspiratory and Expiratory Muscle Training Protocols on Dialysis Dependent Chronic Kidney Disease Patients |
|
Scientific Title of Study
|
Efficacy of different Inspiratory and Expiratory Muscle Training protocols on Cardiopulmonary Parameters in Dialysis Dependent Chronic Kidney Disease Patients: A Comparative 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 |
Neha Reyalch |
| Designation |
Assistant Professor |
| Affiliation |
S.G.T University |
| Address |
Faculty of Physiotherapy
SGT University, Gurugram
Gurgaon
HARYANA
122006
India |
| Phone |
8826043916 |
| Fax |
|
| Email |
nehareyalch09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neha Reyalch |
| Designation |
Assistant Professor |
| Affiliation |
S.G.T University |
| Address |
Faculty of Physiotherapy
SGT University, Gurugram
Gurgaon
HARYANA
122006
India |
| Phone |
8826043916 |
| Fax |
|
| Email |
nehareyalch09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neha Reyalch |
| Designation |
Assistant Professor |
| Affiliation |
S.G.T University |
| Address |
Faculty of Physiotherapy
SGT University, Gurugram
Gurgaon
HARYANA
122006
India |
| Phone |
8826043916 |
| Fax |
|
| Email |
nehareyalch09@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SGT University |
| Address |
Budhera Gurugram |
| 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 |
| Dr Neha Reyalch |
SGT Hospital Gurugram |
SGT University Budhera Gurugram
Gurgaon
HARYANA |
8826043916
nehareyalch09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J989||Respiratory disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1-Inspiratory Muscle Training + Pulmonary Rehab
|
Patient Will Perform Inspiratory Muscle Training along with Pulmonary Rehab which includes aerobic Training and Chest Expansions Exercises |
| Intervention |
GROUP 2- Expiratory Muscle Training + Pulmonary rehab |
Patient will perform the PEP Expiratory Muscle Training along with Pulmonary rehab which includes aerobic training and chest Expansion Exercise |
| Comparator Agent |
GROUP 3 - Conventional Pulmonary rehab |
1. Deep breathing exercises
2. Spirometry
3. Chest expansion exercises |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with chronic kidney disease who are on hemodialysis for more than 3 months with or without cardiopulmonary complications.
2. The study will include men and women older than 18 years.
|
|
| ExclusionCriteria |
| Details |
1. History of arrhythmias (6 months)
2. Unstable angina.
3. Severe lung carcinoma
4. Severe valve disease
5. Spinal cord injured patient
6. Patient with lower limb amputation
7. Decompensated Diabetes Mellitus and Hypertension
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Inspiratory Muscle strength
2 Expiratory Muscle strength |
Day 1 Assessment
4th Week Assessment
8th Week Assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Diaphragm thickness
2. Pulmonary function test
3. liver function test
4. kidney function test
5. Glomerular filtration rat
6. 6 min walk test & vo2 max
7. Quality of life |
Day 1 Assessment
4th Week Assessment
8th Week Assessment |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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 1 |
|
Date of First Enrollment (India)
|
09/12/2024 |
| 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="0"
Months="8"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nehareyalch09@gmail.com].
- For how long will this data be available start date provided 30-11-2025 and end date provided 31-01-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
CKD is not only a major risk factor for dialysis but also increased the
risk of cardiovascular, respiratory, musculoskeletal, immune, endocrine and
metabolic system. The reduced lung function leads to endothelial alteration.
The cardiovascular diseases are collectively the main cause of death in patients
with undergoing hemodialysis. The reduction in the inspiratory and expiratory
muscle strength, is evaluated by maximum inspiratory pressure(MIP). Thus
inspiratory muscle training could improve functional capacity in hemodialysis
patient. However, the effect of threshold IMT and threshold PEP IMT with
integrated renal rehabilitation have not yet compared with the cardiopulmonary
complication in CKD patient. Null Hypothesis
H01. The effect of
Threshold IMT with integrated rehabilitation will not produce any change in the
muscle strength, PFT, GFR, cardiorespiratory fitness in dialysis depended CKD
patient.
H12
The
effect of Threshold PEP IMT with integrated rehabilitation will not produce any
change in the muscle strength, PFT, GFR, LFT, KFT, Diaphragm thickness and cardiorespiratory fitness in dialysis-dependent CKD patients.
H23
The
effect of threshold IMT and threshold PEP IMT with integrated renal
rehabilitation there will be no comparison in the muscle strength, PFT, GFR, LFT, KFT, Diaphragm thickness and
cardiopulmonary fitness in dialysis-dependent CKD patients.
Alternate Hypothesis
H1. The effect of
Threshold IMT with integrated rehabilitation will produce changes in the
muscle strength, PFT, GFR, LFT, KFT, Diaphragm thickness and cardiorespiratory fitness in dialysis-dependent CKD
patients.
H2 The effect of Threshold
PEP IMT with integrated rehabilitation will produce changes in the muscle
strength, PFT, GFR, LFT, KFT, Diaphragm thickness and cardiorespiratory fitness in dialysis-dependent CKD patients.
H3 The effect of threshold
IMT and threshold PEP IMT with integrated renal rehabilitation there will be a
comparison in the muscle strength, PFT, GFR, LFT, KFT, Diaphragm thickness and cardiopulmonary fitness in
dialysis-dependent CKD patients. |