| CTRI Number |
CTRI/2022/08/044752 [Registered on: 18/08/2022] Trial Registered Prospectively |
| Last Modified On: |
17/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To check the effect respiratory muscle training, Pranayama and cycling in kidney disease patients |
|
Scientific Title of Study
|
Additive Effect of Intradialytic Inspiratory Muscle Training, Aerobic Exercise and Pranayama on Toxin Removal, Pulmonary Functions and Quality of Life in Chronic Kidney Disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sofia B Chettiar |
| Designation |
Masters of Cardio-pulmonary Physiotherapy Student |
| Affiliation |
Maharashtra Institute of Physiotherapy |
| Address |
MIP College of Physiotherapy, MIMSR Medical Campus, Ambajogai Road, Vishwanathpuram, Latur
MIP College of Physiotherapy, MIMSR Medical Campus, Ambajogai Road, Vishwanathpuram, Latur
Latur
MAHARASHTRA
413512
India |
| Phone |
9619038607 |
| Fax |
|
| Email |
chettiarsofia96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishvnath S Pawadshetty |
| Designation |
HOD of Cardio-pulmonary Physiotherapy |
| Affiliation |
Maharashtra Institute of Physiotherapy |
| Address |
MIP College of Physiotherapy, MIMSR Medical Campus, Ambajogai Road, Vishwanathpuram, Latur
MIP College of Physiotherapy, MIMSR Medical Campus, Ambajogai Road, Vishwanathpuram, Latur
Latur
MAHARASHTRA
413512
India |
| Phone |
9422710990 |
| Fax |
|
| Email |
physiovish@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sofia B Chettiar |
| Designation |
Masters of Cardio-pulmonary Physiotherapy Student |
| Affiliation |
Maharashtra Institute of Physiotherapy |
| Address |
MIP College of Physiotherapy, MIMSR Medical Campus, Ambajogai Road, Vishwanathpuram, Latur
MIP College of Physiotherapy, MIMSR Medical Campus, Ambajogai Road, Vishwanathpuram, Latur
MAHARASHTRA
413512
India |
| Phone |
9619038607 |
| Fax |
|
| Email |
chettiarsofia96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yeshwantrao Chavan Rural Hospital, Dialysis centre
MIMSR Medical Campus, Ambajogai Road, Vishwanathpuram, Latur |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Sofia B Chettiar |
MIP College of Physiotherapy |
MIP College of Physiotherapy, MIMSR Medical Campus, Ambajogai Road, Vishwanathpuram, Latur
Latur
MAHARASHTRA |
9619038607
chettiarsofia96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharashtra Institute of Physiotherapy Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aerobic exercise |
Cycling for 20 mins with intensity between 2 to 3 on modified Borg scale
2 days per week for 8 weeks |
| Intervention |
Inspiratory Muscle Training |
Resistance will be set at 40% of PImax 5 sets of 5 repetition with 60 seconds of break in between the sets.
2 days per week for 8 weeks
|
| Comparator Agent |
NIL |
NIL |
| Intervention |
Pranayama |
Pranayama will be given 2 sets for 3 mins with 1 min of break in between the sets.
2 days per week for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Known Case of Chronic Kidney Disease (Stages III to V) for >2 years
Should be able to complete six-minute walk test
Patients willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Unstable Vitals
Recent sequelae of cerebrovascular accidents (i.e, in the last three months)
Osteoarticular or musculoskeletal incapacitating disease of lower extremity
Rest-less leg syndrome
COPD
Mentally Unstable patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pulmonary Function Test will be assessed with a portable spirometer
|
Baseline and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Kidney functions will be assessed by measuring blood urea and creatinine by kidney function test |
Baseline and 8 weeks |
| Quality of life will be assessed using Kidney Disease Quality of Life Questionarie |
Baseline and 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
28/08/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Intradialytic Inspiratory Muscle Training, Aerobic Exercise and Pranayama will be given to the intervention group after which Pre an Post values of Kidney Function test, Pulmonary Function Test and Quality of Life will be assessed after 8 weeks of intervention |