| CTRI Number |
CTRI/2024/05/067594 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Exercise Program on Physical Activity, Depression and Quality of Life in Diabetic Nephropathy Patients
|
|
Scientific Title of Study
|
Effect of Exercise Therapeutic Program on Physical Function, Depression and Quality of Life in Diabetic Nephropathy Patients: An Experimental 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 |
Shetty Kashish Prabhakar |
| Designation |
Post graduate student |
| Affiliation |
Nitte Institute of Physiotherapy, Nitte Deemed to be university |
| Address |
Department Of Physiotherapy, Room No-20, Second Base Division, Nitte Institute of Physiotherapy,NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9606130170 |
| Fax |
|
| Email |
shettykashish07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Purusotham Chippala |
| Designation |
Professor |
| Affiliation |
Nitte Institute of Physiotherapy, Nitte Deemed to be university |
| Address |
Department Of Physiotherapy, Room No-20, Second Base Division, Nitte Institute of Physiotherapy,NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9916460185 |
| Fax |
|
| Email |
chippala_puru@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Purusotham Chippala |
| Designation |
Professor |
| Affiliation |
Nitte Institute of Physiotherapy, Nitte Deemed to be university |
| Address |
Department Of Physiotherapy, Room No-20, Second Base Division, Nitte Institute of Physiotherapy,NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9916460185 |
| Fax |
|
| Email |
chippala_puru@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Nitte Institute of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Nitte Institute of Physiotherapy |
| Address |
Nitte Institute of Physiotherapy Nitte Deemed to be University, Nithyananda Nagar, Deralakatte Mangaluru
Dakshina Kannada
Karnataka
575018
India |
| 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 Purusotham Chippala |
Justice K.S Hegde Charitable Hospital |
Department no.27, Department of Nephrology,Medical Science Complex,Deralakatte,Mangaluru-575018
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA |
9916460185
chippala_puru@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Nitte Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Exercise Therapeutic Program |
The intervention will be given 3 times for 8 weeks during first hour of hemodialysis
The procedure will include:
-Relaxation exercises
-Neck Range of motion exercises(2 reps x10 times)
-Upper limb exercises for non-cannulated arm(2 reps x 10 times)
-Lower limb exercises(2 reps x 10 times)
-Strengthening exercises with weight cuffs/resistance bands |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients, both male and female, 35 to 50 years of age
2. The population that speaks Kannada and English
3. Diabetic nephropathy and type 2 diabetes are present in the patients.
4.Less than 13 mL·h−1·kg−1 is the targeted ultrafiltration rate.
5. Individuals receiving hemodialysis two or three times per week
6. BMI (body mass index) more than 26 |
|
| ExclusionCriteria |
| Details |
1.Erratic vital signs
2. Individuals with symptoms or recent hospitalizations
3. Missed prior HD session
4.Ineffective central venous catheter or arteriovenous fistula |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Physical Function Test with 6 minute walk test, 30 seconds sit to stand test, Hand grip strength of non cannulated arm using dynamometer and Lower limb strength using dynamometer will be assessed.
Hospital Anxiety and Depression scale (HADS) for assessing depression in patients with Diabetic Nephropathy.
Kidney Disease Quality of life (KDQoL) questionnaire for assessing health related quality of life in Diabetic nephropathy patients |
Pre-Intervention (1st Day) and Post intervention and intervention period is 3 times for 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="15" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
06/02/2025 |
| 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)
|
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
|
End stage renal disease or Diabetic Nephropathy or diabetic kidney disease is characterized by decrease in urine protein. These patients experience cardiovascular complications which impair kidney function and general body deterioration . Because of burden of physical symptoms and psychological discomfort , end stage renal disease patients with Hemodialysis Maintainence along diabetic nephropathy have a lower health related quality of life and may have state of depression which also leads to poor physical function. Importance for exercise therapy is highlighted in guidelines of National Kindey foundation to increase physical activity in patients .There are two ways that exercise training can be
administered: as an intradialytic (during dialysis) or extra dialytic (after
dialysis). Studies have indicated that while extra dialytic exercise may yield
greater advantages in terms of functional ability and exercise capacity,
compliance with extra dialytic therapies is lower. The American College of Sports Medicine (ACSM)
guidelines for an exercise prescription state that people with hemodialysis
(HD) should exercise three to five days a week So the need of this study is to determine
how the patients responded to the exercises and how they improved in terms of activities of daily living
as well as mental health and
quality of life |