| CTRI Number |
CTRI/2025/03/082711 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How taking multiple medications affects the health and quality of life of older dialysis patients with chronic kidney disease |
|
Scientific Title of Study
|
Association of Polypharmacy with Physical Fitness and Quality of Life in Elderly Hemodialysis Patients with Chronic Kidney Disease: An Observational 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 |
RakshaPB |
| Designation |
Post Graduate student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced physiotherapy Center,Room No. 39, Sagar Floor, Dr.Prabhakar Kore Hospital and MRC. Belgaum KARNATAKA 590010 India
Belgaum
KARNATAKA 590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
7259597207 |
| Fax |
|
| Email |
rakshapbprakash@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAnil Muragod |
| Designation |
Professor and Head of Department of Geriatrics Physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced physiotherapy centre,Room No. 39, Sagar Floor, KLE hospital Dr.Prabhakar Kore Hospital and MRC. Belgaum KARNATAKA 590010 India
KARNATAKA 590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
08312473906 |
| Fax |
|
| Email |
anilmurgod@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
RakshaPB |
| Designation |
Post Graduate student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced physiotherapy Center,Room No. 39, Sagar Floor, Dr.Prabhakar Kore Hospital and MRC. Belgaum KARNATAKA 590010 India
Belgaum
KARNATAKA 590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
7259697207 |
| Fax |
|
| Email |
rakshapbprakash@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tertiary care hospital, Belagavi KARNATAKA 590010
|
|
|
Primary Sponsor
|
| Name |
KAHER institute of physiotherapy |
| Address |
KAHER institute of physiotherapy,JNMC campus,Nehru nagar,Belagavi |
| 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 |
| RakshaPB |
Dr.Prabhakar Kore hospital |
Advanced physiotherapy centre,Room No. 39, Sagar Floor, KLE
hospital Dr.Prabhakar Kore Hospital and MRC. Belgaum
KARNATAKA 590010 India
KARNATAKA
590010
India
Belgaum
KARNATAKA |
7259697207
rakshapbprakash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and ethical committee KAHER institute of physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Elderly Hemodialysis Patients with Chronic Kidney Disease |
| Patients |
, (1) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female elderly 65 and above
Score ≥24 on the Mini Mental State Examination
Dialysis patients with CKD Patients receiving dialysis for at least 3 months, minimum of 25 sessions 30min after dialysis all the outcome measures will be assessed elderly using ≥5 prescribed medications concurrently
Patient able to walk with or without walking aids for 100mts
|
|
| ExclusionCriteria |
| Details |
Individuals who have undergone surgery or been hospitalized in the past three months.
Lower limb amputations
Severe visual or hearing loss
Patients with neurological conditions, such as stroke,ALS,MS;
Orthopedic conditions, such as severe osteoarthritis,recent fractures ;
Diagnosed Unstable angina,post-CABG,pulmonary embolism,myocardial infarction
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the correlation of polypharmacy on physical fitness and quality of life (QoL) in elderly hemodialysis patients with chronic kidney disease (CKD)using
Five-Time Sit-to-Stand Test (FTSST) Six-Minute Walk Test (6MWT) Lower Extremity Functional Scale (LEFS)Chair sit and Reach Test Kidney Disease and Quality of Life (KDQOLâ„¢-36) |
T0 at the time of pre assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
06/04/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Subjects will be screened based on inclusion and exclusion criteria from various parts of Belagavi City.Before participating in the study, participants will be told of its objective and will be required to sign a written informed consent form.Data will be collected over a six-month period, with a systematic evaluation capturing demographic information, medication use, and medical history. The study will use validated outcome measures to assess physical fitness and quality of life, such as the FTSST, 6MWT, LEFS, Chair Sit and Reach Test, and KDQOL-36 questionnaire. After collecting the data, the goal is to provide insights into how polypharmacy affects physical fitness and quality of life. |