| CTRI Number |
CTRI/2025/01/079149 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [digital health interventions including mobile applications, calisthenic video, step count] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Digital health interventions on physical activity and quality of life among hemodialysis patients. |
|
Scientific Title of Study
|
A pilot study to investigate the effectiveness of Digital health interventions on physical activity and quality of life among hemodialysis patients at AIIMS, New Delhi. |
| 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 Manju Amit Kumar Rajora |
| Designation |
Associate Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no.2 College of Nursing AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9870260036 |
| Fax |
|
| Email |
manjuakrajora@aiims.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manju Amit Kumar Rajora |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no.2, Deptt of College of Nursing, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9870260036 |
| Fax |
|
| Email |
manjuakrajora@aiims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manju Amit Kumar Rajora |
| Designation |
Associate Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no.2 College of Nursing AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9870260036 |
| Fax |
|
| Email |
manjuakrajora@aiims.edu |
|
|
Source of Monetary or Material Support
|
| Research Section, AIIMS, Ansari Nagar, New Delhi |
|
|
Primary Sponsor
|
| Name |
Research Section AIIMS New Delhi |
| Address |
AIIMS, Ansari Nagar, New Delhi-110029 |
| 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 Manju AK Rajora |
AIIMS, New Delhi |
Dialysis Unit, AB4 ward, Deptt of Nephrology
New Delhi
DELHI |
9870260036
manjuakrajora@aiims.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N185||Chronic kidney disease, stage 5, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Digital Health Interventions |
Each participant will be provided with a wearable device (specification are being studied at this point). Wearable device-based walking would include, the calisthenics including stretching, aerobic and resistance training. Calisthenics exercises would include an 18-min video prepared by PI and validated by subject experts. The video would include stretching, aerobic and resistance training, and could be performed in a sitting or standing position. Participants will be asked to perform the exercises at least three times a week. Each participant will download an app (the app to be developed, discussed with IT professional) to connect with the health management platform. Participants exercise-related data, including number of steps walked, distance, consumed calories, and heart rate, will be collected through the wearable devices. All participants will be taught to record a dietary diary by plate /bowl portion throughout the day using a smartphone application. All collected information will be uploaded to the health management platform. Only the researchers would be able to access the data on the health management platform. The calories and nutrients in the food, such as starches, proteins, and lipids, and the percentage of vegetables and fruits will be calculated after standardising with the dietician. The necessary advice about diet will be given to the participants by the PI accordingly.
User interface of the health management platform software would include blood pressure management, weight management, exercise management, blood sugar management, Smart wristband, online instruction and my progress. A WhatsApp group will be created to motivate the participants, especially when the daily target step count will be achieved. Teleconsultations of health information will be provided by the PI from 6 to 7pm as and when required by the participants via WhatsApp.
Frequency of the intervention: Calisthenic exercises: three times a week
Walking: everyday
Duration of intervention: 12 months
Baseline assessment: Daily and monthly step count (self-reported). Blood chemistry including Hb, Na, Ca, K, albumin, urea and creatinine, and vitals (heart rate, respiration rate, blood pressure), Quality of life and other objective measures of physical activity (STS-10, STS-60, 6MWT and HGS).
At 3rd, 6th, 9th and 12th month after the intervention: Daily and monthly step count (by wearable device), Blood chemistry including Hb, Na, Ca, K, albumin, urea and creatinine, and vitals (heart rate, respiration rate, blood pressure), Quality of life and other objective measures of physical activity (STS-10, STS-60, 6MWT and HGS). |
| Comparator Agent |
Standard Treatment to the Maintenance hemodialysis patient |
Patients on maintenance hemodialysis will get the standard treatment only. There will be no intervention given to them.
Baseline: Assessment of daily and monthly step count (self-reported), monthly step count (self-reported). Blood chemistry including Hb, Na, Ca, K, albumin, urea and creatinine, and vitals (heart rate, respiration rate, blood pressure), Quality of life and other objective measures of physical activity (STS-10, STS-60, 6MWT and HGS).
At 3rd, 6th, 9th and 12th months: Assessment of daily and monthly step count (self-reported), monthly step count (self-reported). Blood chemistry including Hb, Na, Ca, K, albumin, urea and creatinine, and vitals (heart rate, respiration rate, blood pressure), Quality of life and other objective measures of physical activity (STS-10, STS-60, 6MWT and HGS). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patients aged 18 years and above with a diagnosis of CKD
on maintenance HD for more than 3 months.
willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Patient:
having inability to use a smartphone
having functional impairment or have pain or discomfort while walking
having any psychiatric disorder
had any hospitalization during the previous 3 months.
change dialysis modality or undergo renal transplantation during the study period.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Daily step count and monthly step count. |
Baseline, and at 3, 6, 9, 12 months after initiation of the study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life and other objective measures of physical activity (STS-10, STS-60, 6MWT and HGS). |
baseline, and at 3, 6, 9, 12 months after initiation of the study. |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
03/02/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Primary
objective
1. To evaluate the effectiveness of digital health
interventions (DHIs) on step count among MHD patients.
Secondary objectives
2. To evaluate the effectiveness of digital health
interventions (DHIs) on the other measures of physical activity (STS-10, STS-60,
6 MWT and HGS) among MHD patients.
3. To evaluate the effectiveness of digital health
interventions (DHIs) on quality of life among MHD patients.
4. To seek a relationship between physical activity,
and quality of life among MHD patients. Research Hypothesis:
H1: MHD patients will have improved step count
after 12 months of DHI intervention than those getting standard care.
H2: MHD patients will have improved physical
activity as measured by STS-6, STS-60 and hand grip after 12 months of digital
health interventions than those getting standard care.
H3: MHD patients will have improved quality of life
as measured by KDQOL after 12 months of digital health interventions than those
getting standard care.
|