| CTRI Number |
CTRI/2023/06/054515 [Registered on: 28/06/2023] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Inspiratory muscle training (IMT) training in CKD patients . |
|
Scientific Title of Study
|
: Effectiveness of inspiratory muscle training on pulmonary functions and
functional capacity in patients with chronic kidney disease on hemodialysis.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr JIGAR METHA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
K.M PATEL INSTITUE OF PHYSIOTHERAPY.BHAIKAKA UNIVERSITY , SHREE KRISHNA HOSPITAL, KARAMSAD |
| Address |
K.M PATEL INSTITUE OF PHYSIOTHERAPY.BHAIKAKA UNIVERSITY , SHREE KRISHNA HOSPITAL, KARAMSAD
PHYSIOTHERAPY DEPARTMENT
ANAND , GUJARAT 388325. INDIA
Anand
GUJARAT
388325
India |
| Phone |
|
| Fax |
|
| Email |
jigarnm@charutarhealth.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr JIGAR METHA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
K.M PATEL INSTITUE OF PHYSIOTHERAPY.BHAIKAKA UNIVERSITY , SHREE KRISHNA HOSPITAL, KARAMSAD |
| Address |
K.M PATEL INSTITUE OF PHYSIOTHERAPY.BHAIKAKA UNIVERSITY , SHREE KRISHNA HOSPITAL, KARAMSAD
PHYSIOTHERAPY DEPARTMENT
ANAND , GUJARAT 388325. INDIA
Anand
GUJARAT
388325
India |
| Phone |
|
| Fax |
|
| Email |
jigarnm@charutarhealth.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aakanksha kulthe |
| Designation |
PG student |
| Affiliation |
K.M PATEL INSTITUE OF PHYSIOTHERAPY.BHAIKAKA UNIVERSITY , SHREE KRISHNA HOSPITAL, KARAMSAD |
| Address |
K.M PATEL INSTITUE OF PHYSIOTHERAPY.BHAIKAKA UNIVERSITY , SHREE KRISHNA HOSPITAL, KARAMSAD
PHYSIOTHERAPY DEPARTMENT
ANAND , GUJARAT 388325. INDIA
Anand
GUJARAT
388325
India |
| Phone |
|
| Fax |
|
| Email |
akankshask@charutarhealth.org |
|
|
Source of Monetary or Material Support
|
| Room no 152 physiotherapy department shree Krishna hospital karamsad . |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| 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 |
| Jigar Mehta |
shree krishna hospital |
room no 152,
K M patel Institute of Physiotherapy
Anand
GUJARAT |
9824771843
jigarnm@charutarhealth.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
| Institutional ethics committe2 |
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 |
| Comparator Agent |
IMT training |
ONE GROUP WILL BE GIVE IMT AND OTHER WILL BE GIVEN CONVENTIONAL PHYSIOTHERAPY. GROUP ONE WILL RECIVE TREATMENT IN FORM OF IMT TRAINING PLUS CONVENTIONAL PHYSIOTHERAPY AND GROUP TWO WILL RECIEVE TREATMENT IN FORM OF GENERAL PHYSIO PLUS BREATHING EXERCISE PLUS RELAXATION EXERCISE |
| Intervention |
Inspiratory muscle training (IMT) |
group 1 will get IMT training A set of five
repetitions, at one-minute intervals, at 40% of MIP, 20 mins during 3 hemodialysis sessions/weeks x 6
weeks). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients receiving hemodialysis >3 months .
Hemodynamically stable |
|
| ExclusionCriteria |
| Details |
Any existing illness which can limit their participation for exercise or affect the understanding |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
primary outcome :- Maximum inspiratory pressure (MIP)
|
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome :- pulmonary function Test .
6 min walk test |
Baseline post intervention after 6 weeks before the dialysis |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/07/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 participants will be recruited into two groups (experimental and control)
based on computer generated random number table.
All the participants will be explained about the purpose and the procedure to be carried out for the research
work . Written informed consent will be obtained from all
before initiating the trial. Experimental group:- The participants will receive treatment in form of IMT training ( a set of five
repetitions, at one-minute intervals, at 40% of MIP, 20 mins during 3 hemodialysis sessions/weeks x 6
weeks) along with the conventional physiotherapy. Control group:- The participants in the Control group will receive the conventional physiotherapy in form
of:
1. General mobility exercises of upper limb (other than the limb having fistula) and lower limb - (10
repetitions, 1 set) Control group:- The participants in the Control group will receive the conventional physiotherapy in form
of:
1. General mobility exercises of upper limb (other than the limb having fistula) and lower limb - (10
repetitions, 1 set) , Diaphragmatic breathing exercise
Treatment will be given three days a week, on alternate days for total of 4 weeks.
|