| CTRI Number |
CTRI/2025/03/082749 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| 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
|
Impact of Exercise and Breathing Training on Physical Health and Quality of Life in Frail CKD Patients: A Clinical Trial |
|
Scientific Title of Study
|
Effectiveness Of Low to Moderate Intensity Aerobic Exercises Along with Inspiratory Muscle Training on Physical Performance, Kinesiophobia and Quality of Life in CKD Patients With Frailty- Randomized 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 |
Dr Gauri Mahendra Sorty |
| Designation |
Masters of Cardiovascular and Respiratory Physiotherapy Student |
| Affiliation |
Maharashtra Institute Physiotherapy , Latur |
| Address |
Maharashtra Institute of Department of Cardiovascular and Respiratory Physiotherapy ,OPD-17,Maharashtra Institute Physiotherapy, MIMSR medical campus, Ambajogai Road ,Latur
Latur
MAHARASHTRA
413531
India |
| Phone |
9021265624 |
| Fax |
|
| Email |
gaurisorty11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishvnath Pawadshetty |
| Designation |
HOD of Cardiovascular and Respiratory Physiotherapy |
| Affiliation |
Maharashtra Institute Physiotherapy , Latur |
| Address |
Maharashtra Institute of Department of Cardiovascular and Respiratory Physiotherapy ,OPD-17,Maharashtra Institute Physiotherapy, MIMSR medical campus, Ambajogai Road ,Latur
Latur
MAHARASHTRA
413531
India |
| Phone |
9422710990 |
| Fax |
|
| Email |
physiovish@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishvnath Pawadshetty |
| Designation |
HOD of Cardiovascular and Respiratory Physiotherapy |
| Affiliation |
Maharashtra Institute Physiotherapy , Latur |
| Address |
Maharashtra Institute of Department of Cardiovascular and Respiratory Physiotherapy ,OPD-17,Maharashtra Institute Physiotherapy, MIMSR medical campus, Ambajogai Road ,Latur
Latur
MAHARASHTRA
413531
India |
| Phone |
9422710990 |
| Fax |
|
| Email |
physiovish@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharashtra Institute of Department of Cardiovascular and Respiratory Physiotherapy ,OPD-17,Maharashtra Institute Physiotherapy, MIMSR medical campus, Ambajogai Road ,Latur |
|
|
Primary Sponsor
|
| Name |
Maharashtra Institute of Physiotherapy,Latur |
| Address |
Maharashtra Institute of Physiotherapy, MIMSR Medical Campus, Ambajogai Road ,Latur 413531 |
| 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 Mahendra Sorty |
Yeshwantrao Chavan Rural Hospital,Latur |
Maharashtra Institute of Department Of Cardiovascular and Respiratory Physiotherapy ,OPD-17,Maharashtra Institute of Physiotherapy, MIMSR medical campus, Ambajogai Road,Latur
Latur
MAHARASHTRA |
09021265624
gaurisorty11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Research on Human Subject |
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 |
1)Aerobic exercise
2)Inspiratory muscle training
|
1)Aerobic exercises content warm up, conditioning program and cool down exercise
2)Inspiratory muscle training is given by inspiratory muscle trainer device |
| Comparator Agent |
Aerobic Exercises only |
Aerobic exercises content warm up, conditioning program and cool down exercise |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)If the score of frailty phenotype criteria is more than or equal to 3 patient consider as a frail
2)Patients should able complete 6 min walk test
3)Resting SPO2 more than or equal to 90 percent
4)Chronicity of the disease (more than 3 months)
|
|
| ExclusionCriteria |
| Details |
1)Uncontrolled DM
2)BP more than 180/110 mmhg or less than 80/60mmhg
3)Muscle pain and cramp
4)RPE greater than or equal to 15
5)Chest pain
6)Arrhythmias
7)Obstructive lung disease
8)History of thoracic and abdominal surgery in past 6 month
9)Osteoarthritis of knee
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Tempa scale for kinesiophobia
2)VO2 max
3)KDQOL-36 |
All outcomes will assess at baseline, at 6th week and 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)6MWT
2)(J-CHS) criteria for frailty |
1)patient is able to complete 6mwt
2) (J-CHS) criteria score equal or more than 3 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/04/2025 |
| 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="1"
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
|
Informed consent will be obtained, and participants (50 individuals aged 18-60) will be selected based on inclusion/exclusion criteria. They will be randomly assigned into two groups: Group A (Intervention) - aerobic exercises with inspiratory muscle training (IMT), and Group B (Control) - aerobic exercises only. Assessments will include physical performance (VO2), kinesiophobia (Tempa scale), and quality of life (KDQOL-36). The exercise protocol will be conducted 3 days per week for 12 weeks, with each session including 5-10 minutes of warm-up, 20-60 minutes of aerobic conditioning, and 5-10 minutes of cool-down. Pre, mid, and post-intervention evaluations will be done for all participants GROUP A: The Aerobic exercise Warm up
exercises (5-10 min): Stretching of large muscle groups like calf ,hamstrings,
quadriceps ,triceps ,biceps, pectoralis major. Conditioning programme (20-60 min) :static cycling, stepping activity, walking (3min each) [2 min of passive interval
after each session] Cool down
exercise (5-10 min):Stretching combined with Active
range of motion exercises of all the peripheral joints. Exercise
prescription will be individualized, with an initial intensity of 40%- 60% of
MHR or/and RPE: 11- 13
Exercise
duration will be increased by 5 min after every 2 weeks (to maximum of 60 mins) Inspiratory
muscle training: 5
series with 10 reps each series 2 min interval overload
adjust weekly; Beginning
with 50% of MIP for 1st to 3rd week ,60%
of MIP for 4th to 6th week,70% of MIP for 7th to 9th
week, 80% of MIP for 10th to 12th week. GROUP B: The Aerobic exercise Warm up exercises (5-10 min): Stretching of large muscle groups like calf ,hamstrings, quadriceps ,triceps ,biceps, pectoralis major. Conditioning programme (20-60 min) :static cycling, stepping activity, walking (3min each) [2 min of passive interval after each session] Cool down exercise (5-10 min):Stretching combined with Active range of motion exercises of all the peripheral joints. Exercise prescription will be individualized, with an initial intensity of 40%- 60% of MHR or/and RPE: 11- 13 Exercise duration will be increased by 5 min after every 2 weeks (to maximum of 60 mins) |