| CTRI Number |
CTRI/2025/10/095563 [Registered on: 03/10/2025] Trial Registered Prospectively |
| Last Modified On: |
02/10/2025 |
| 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
|
A Study Comparing Two Types of Exercises Done During Dialysis to Improve Strength, Balance, and Quality of Life in Older Patients with Chronic Kidney Disease |
|
Scientific Title of Study
|
Comparison of Two Forms of Intradialytic Exercises on Strength, Balance and Quality of life in Elderly Hemodialysis Patients with CKD:A Randomized Clinical 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 |
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
Belgaum
KARNATAKA
590010
India |
| Phone |
07259697207 |
| Fax |
|
| Email |
rakshapbprakash@gmail.com |
|
Details of Contact Person
Scientific 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
Belgaum
KARNATAKA
590010
India |
| Phone |
07259697207 |
| Fax |
|
| Email |
rakshapbprakash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil Muragod |
| Designation |
Professor and Head of Department of Geriatrics Physiotherapy |
| 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 |
| Phone |
07259697207 |
| Fax |
|
| Email |
anilmuragod@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr. Prabhakar Kore hospital and MRC.Belgaum KARNATAKA 590010 INDIA |
|
|
Primary Sponsor
|
| Name |
Self sponsored Project |
| Address |
Advanced physiotherapy Center,Room No. 39, Sagar Floor, Dr.Prabhakar Kore Hospital and MRC. Belgaum KARNATAKA 590010 India |
| 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 |
| DrRakshaPB |
Dr.Prabhakar Kore Hospital Belgaum |
Advanced physiotherapy Center,Room No. 39, Sagar Floor, Dr.Prabhakar Kore Hospital
Belgaum
KARNATAKA 590010 India
Belgaum
KARNATAKA |
07259697207
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 |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Podiatric Exercises
|
The route or mode of intervention will be intradialytic exercise performed during the first one to two hours of dialysis. The frequency will be two times per week and the duration will be eight weeks. Each session will include five minutes of warm up, twenty minutes of ankle mobility and strengthening exercises, and five minutes of cool down. The program will consist of ankle circles, ankle dorsiflexion and plantar flexion movements, toe spreading, toe curling using a towel, resistance band exercises for dorsiflexion, plantar flexion, inversion and eversion, and plantar fascia stretches. The intensity of exercise will be maintained at fifty five to sixty percent of maximum heart rate. This program will emphasize resistance and flexibility training. |
| Intervention |
Static Cycling and Stretching |
The route or mode of intervention will be intradialytic exercise performed during the first one to two hours of dialysis. The frequency will be three times per week and the duration will be eight weeks. Each session will include five minutes of warm up, ten minutes of static cycling, and ten minutes of stretching of the tibialis anterior and hamstring muscles. The intensity of exercise will be maintained at fifty five to sixty percent of maximum heart rate. This program will focus on aerobic, resistance, and flexibility training. |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
The study will include both male and female elderly individuals aged sixty five years and above with a score of greater than twenty four on the Mini Mental State Examination as described by Folstein in nineteen seventy five. Patients scoring between twenty one and fifty six on the Berg Balance Scale indicating mild to moderate impairment will be included. Participants will be patients with chronic kidney disease who have been receiving dialysis for at least three months with a minimum of twenty five sessions. The intervention will be delivered during the first one to two hours of ongoing dialysis and outcome measures will be assessed thirty minutes after dialysis. |
|
| ExclusionCriteria |
| Details |
Individuals who have undergone surgery or been hospitalized in the past three months will be excluded. Participants with lower limb amputations, severe balance impairments, severe visual or hearing loss, or neurological conditions such as stroke, amyotrophic lateral sclerosis, or multiple sclerosis will not be included. Patients with orthopedic conditions such as severe osteoarthritis or recent fractures, and those diagnosed with unstable angina, post coronary artery bypass grafting, pulmonary embolism, or myocardial infarction will also be excluded. All of these conditions are considered absolute contraindications for exercise. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. 30-Second Chair Stand 18
2.Berg Balance Scale
3. Kidney Disease and Quality of Life (KDQOL™-36) 20
|
8 WEEKS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcomes of the study will include changes in balance measured by the Berg Balance Scale, changes in lower limb muscle strength assessed by manual muscle testing, changes in ankle mobility assessed using goniometry, changes in quality of life assessed using the Kidney Disease Quality of Life Short Form questionnaire, and changes in fatigue levels assessed by the Fatigue Severity Scale. All these outcomes will be measured at baseline and again after eight weeks of intervention. |
0th week,4th week,8th week |
|
|
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)
|
15/10/2025 |
| 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
|
The study will include both male and female elderly individuals aged 65 years and above with a Mini Mental State Examination score of 24 or more and a Berg Balance Scale score between 21 and 56 indicating mild to moderate impairment. Participants will be patients with chronic kidney disease undergoing dialysis for at least three months with a minimum of twenty five sessions. The intervention will be delivered during the first one to two hours of ongoing dialysis and outcome measures will be assessed thirty minutes after dialysis. Group A will perform static cycling and stretching three times per week for eight weeks at an intensity of fifty five to sixty percent of maximum heart rate. The program will include five minutes of warm up ten minutes of cycling and ten minutes of stretching of the tendoachilis and hamstrings focusing on aerobic resistance and flexibility training. Group B will undergo podiatric exercises twice per week for eight weeks at the same intensity. This will consist of five minutes of warm up twenty minutes of ankle mobility and strengthening exercises and five minutes of cool down emphasizing resistance and flexibility. The podiatric exercise program will include ankle circles ankle dorsiflexion and plantar flexion toe spreading toe curling using a towel resistance band exercises for dorsiflexion plantar flexion inversion and eversion and plantar fascia stretches thereby targeting ankle mobility and strengthening during dialysis sessions. |