| CTRI Number |
CTRI/2024/02/063342 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
22/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate the effectiveness of a nurse administered special breathing exercise on body fatigue and quality of life |
|
Scientific Title of Study
|
Efficacy of Nurse Executed Low Intensity Breathing Based Leg Exercises on Biochemical Parameters, Fatigue and Health-related Quality of Life among Haemodialysis Patients
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Maryelizabeth Tidiya Walarine |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Medical-Surgical Nursing
MIMS College of Nursing
Malappuram
No.1,Ramachandra Nagar
Porur
Chennai
Malappuram
KERALA
673633
India |
| Phone |
9074783041 |
| Fax |
|
| Email |
maryelizabethtidiyawalarine@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh C |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Faculty of NUrsing,
Sri Ramachandra Institute of Higher Education and Research, Porur,Chennai
No.1,Ramachandra Nagar
Porur
Chennai
Chennai
TAMIL NADU
600 116
India |
| Phone |
9880055512 |
| Fax |
|
| Email |
ramesh.c@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh C |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Medical-Surgical Nursing
Sri Ramachandr Faculty of Nursing,
Sri Ramachandra Institute of Higher Education and Research, Porur,Chennai
No.1,Ramachandra Nagar
Porur
Chennai
KERALA
600116
India |
| Phone |
9880055512 |
| Fax |
|
| Email |
ramesh.c@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr.Sajith Narayanan
Head,Department of Nephrology
MIMS Hospital
Govindapuram
Kozhikode
Kerala
|
|
|
Primary Sponsor
|
| Name |
Maryelizabeth Tidiya Walarine |
| Address |
MIMS College of Nursing
Malappuram
Kerala |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| MIMS Hospital |
Govindapuram
Kozhikode
Kerala
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sajith Narayanan |
Aster MIMS Hospital |
Department of Nephrology
Room No-320
Govindapuram P.O
Kozhikode
Kerala
673016
Kozhikode
KERALA |
04952488000
mimsclt@asterhospital.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Malabar Institute of Medical Sciences (MIMS) |
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
|
| Type |
Name |
Details |
| Intervention |
Nurse Executed Low Intensity Breathing Based Leg Exercises |
The low-intensity leg exercise comprises leg lifts, quadriceps femoris contraction, and knee
flexion. Participants will lie on their back with both feet flat on the bed.
In the first exercises, patients will raise the right leg straight out at 30°–40°, hold for five
seconds, and then slowly lower their leg to the start position before doing the same motion with
the left leg.
For the second exercise, participants will bend both knees, elevate the right calf, and straighten
the right knee for five seconds before slowly lowering the leg and returning to the start position.
This motion will be then repeated with the left leg before participants returning to lying on their
back with both feet flat on the bed.
For the third exercise, participants will elevate their straightened right leg at 30°–40°, bend the
right knee to a 90° angle, and then slowly lower the leg to the start position. This will be repeated
with the opposite knee. Throughout the exercise, the breath will not be held but should be
focused.
Right after the leg exercises, participants will perform abdominal breathing by placing both
hands below the umbilicus, doing a controlled exhale slowly until the hands will be flat on the
abdomen, and inhaling deeply until the abdomen push forward both hands. Participants will be
required to exhale for six seconds through pursed lips and then inhale for three seconds through
the nose.
Exercises will be made to be done by the patient for 15 minutes, three times a week. Patient will be followed up three times weekly until 3 months when he/she visits the Dialysis department
|
| Comparator Agent |
Routine care |
Patients will be receiving routine care from the
Haemodialysis department such as Physician advice, Nephrologist advice, dietary guidance,
follow-up instructions, lifestyle modification and disbursement of medications. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients
1) of either gender above 20 years
2) diagnosed as ESRD
3)undergoing haemodialysis treatment three times per week for at least 3 months
|
|
| ExclusionCriteria |
| Details |
Patients,
1) with any musculoskeletal and neurological conditions limiting mobility of lower
limbs
2) with altered level of consciousness
3) who are undergoing peritoneal dialysis
4) with severe heart disease or unstable angina
5) who have shortness of breath at rest |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fatigue |
Baseline, Week 4, Week 8, Week 12, 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of Life
|
Baseline, Week 4, Week 8, Week 12, 3rd Month and 6th Month |
| S Albumin, S Calcium, S Phosphorus and Vitamin D3 |
Baseline, Week 4,week Week 8, Week 12, 3rd month |
|
|
Target Sample Size
|
Total Sample Size="190"
Sample Size from India="190"
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)
|
04/03/2024 |
| 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="2"
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
|
End stage renal disease (ESRD) is the 12th leading cause of death worldwide and the 8th in India. Haemodialysis is an important and common treatment method adopted for ESRD. Fatigue is commonly reported among patients receiving
haemodialysis and is debilitating.A 12-week breathing-based leg exercise program helped enhance quality of life among
haemodialysis patients. In spite of the numerous pieces of evidence regarding the benefits of exercises, it is not used as part of standard care for patients undergoing
haemodialysis.It was found that low-intensity exercise leads to removal of small solutes like potassium.
phosphate and urea nitrogen.The current study aims to evaluate the efficacy of nurse-executed low-intensity breathing-based leg exercises on
selected biochemical parameters, fatigue, and health-related quality of life among
haemodialysis patients and thereby enable patients undergoing haemodialysis to reduce
fatigue and maintain a better quality of life with improved biochemical measures.The study tries to evaluate the following hypothesis: H1: -There will be significant difference in mean pre-test and post-test scores of biochemical
parameters among patients undergoing haemodialysis in interventional group with that of control
group. H2: There will be significant difference in mean pre-test and post-test scores of fatigue among
patients undergoing haemodialysis in interventional group compared with the control group. H3: There will be significant difference in mean pre-test and post-test scores of health-related
quality of life among patients undergoing haemodialysis in interventional group with that of
control group. |