| CTRI Number |
CTRI/2021/10/037241 [Registered on: 11/10/2021] Trial Registered Prospectively |
| Last Modified On: |
21/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Functional Capacity, Physical Activity Level and Quality of life in Adult patients with End Stage Renal Disease on Hemodialysis. |
|
Scientific Title of Study
|
Correlation of Functional Capacity with Physical Activity Level and Quality of Life in Adult patients with End Stage Renal Disease on Hemodialysis- A Pilot Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ECARP/2021/58 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rachna Arora |
| Designation |
Assistant Professor |
| Affiliation |
Physiotherapy School and Centre, TNMC. |
| Address |
Physiotherapy School And Centre, Topiwala National Medical College, Mumbai Central.
Mumbai
MAHARASHTRA
400008
India |
| Phone |
02223027503 |
| Fax |
|
| Email |
rachna2arora@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aditi Gajanan Padki |
| Designation |
Postgraduate Student |
| Affiliation |
Physiotherapy School and Centre, TNMC. |
| Address |
Physiotherapy School And Centre, Topiwala National Medical College, Mumbai Central.
Mumbai
MAHARASHTRA
400008
India |
| Phone |
8591016355 |
| Fax |
|
| Email |
aditipadki96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditi Gajanan Padki |
| Designation |
Postgraduate Student |
| Affiliation |
Physiotherapy School and Centre, TNMC. |
| Address |
Physiotherapy School And Centre, Topiwala National Medical College, Mumbai Central.
Mumbai
MAHARASHTRA
400008
India |
| Phone |
8591016355 |
| Fax |
|
| Email |
aditipadki96@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Physiotherapy School and Centre Topiwala National Medical College and BYL Nair Ch Hospital |
| Address |
Physiotherapy School And Centre, Topiwala National Medical College and BYL Nair Ch Hospital, Mumbai Central- 400008 |
| Type of Sponsor |
Government 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 |
| Rachna Arora |
Topiwala National Medical College and BYL Nair Ch Hospital. |
Artificial Kidney Division Unit,7th floor, OPD building,
Topiwala National Medical College and BYL Nair Hospital, Mumbai Central- 400008
Mumbai
MAHARASHTRA |
02223027503
rachna2arora@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Academic Research Projects (ECARP) PG Academic Committee, T.N Medical College and BYL Nair Ch. Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ESRD patients on haemodialysis for more than 3 months
2. Adult in the age group of 18-60 years
3. Kt/V ratio- 1.2
4. Patient willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1. Resting SBP > 140 mm Hg and SBP < 100 mm Hg
2. Resting DBP > 100 mm Hg
3. Ejection fraction < 50%
4. Hemoglobin < 9 mg/dl
5. Any cardiac event within 2 months
6. Any cardiac surgery within 6 months
7. Recent respiratory infection in past 3 months
8. Resting oxygen saturation < 92% as measured by finger pulse oximeter
9. Patients who are not ambulatory
10. Patients unable to understand and follow verbal commands
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Functional Capacity with the help of 6 minute walk test.
2. Physical activity level with the help of International Physical Activity Questionnaire(IPAQ).
3. Quality of life with the help of Kidney Disease Quality Of life Short Form (KDQOL-SF). |
One time assessment of patients will be done with total duration of assessment not exceeding 45 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/10/2021 |
| Date of Study Completion (India) |
17/07/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is an Observational, Cross-sectional Pilot study to correlate the functional capacity with physical activity level and quality of life in adult patients with end stage renal disease on hemodialysis.
The outcome measure that will be used to measure the functional capacity is 6 minute walk test, International Physical activity level Questionnaire (IPAQ) will be used to measure the physical activity level and Kidney disease quality of life questionnaire - Short form ver. 1.3 will be used to asses the quality of life in these patients. |