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CTRI Number  CTRI/2024/08/072832 [Registered on: 21/08/2024] Trial Registered Prospectively
Last Modified On: 21/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [respiratory muscle training]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A clinical trail to study Effect of Nurse-Guided Respiratory Muscle exercise on Respiratory Functional Capacity and Muscle Strength In Patients With Haemodialysis  
Scientific Title of Study   Effect of Nurse-Led Respiratory Muscle Training on Functional Capacity and Respiratory Muscle Strength In Patients With Haemodialysis: A Quasi-Experimental 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  Abhishek Barra 
Designation  PG Student  
Affiliation  COLLEGE OF NURSING , AIIMS JODHPUR  
Address  Seminar hall-2, first floor, College of Nursing, AIIMS JODHPUR, Basni phase-2.

Jodhpur
RAJASTHAN
342005
India 
Phone  7340278303  
Fax    
Email  abhishekbarra2@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mr Nipin Kalal 
Designation  Assisstant Professor  
Affiliation  COLLEGE OF NURSING , AIIMS JODHPUR  
Address  Room no.- 106, first floor, College of Nursing, AIIMS JODHPUR, Basni phase-2.

Jodhpur
RAJASTHAN
342005
India 
Phone  8955945598  
Fax    
Email  kalalnipin@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mr Nipin Kalal 
Designation  Assisstant Professor  
Affiliation  COLLEGE OF NURSING , AIIMS JODHPUR  
Address  Room no.- 106, first floor, College of Nursing, AIIMS JODHPUR, Basni phase-2.

Jodhpur
RAJASTHAN
342005
India 
Phone  8955945598  
Fax    
Email  kalalnipin@gmail.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR, RAJASTHAN 342005.INDIA 
 
Primary Sponsor  
Name  Non sponsored 
Address  NIL 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Abhishek barra  All india institute of medical science, Jodhpur  5th Floor, OPD , NEPHROLOGY DEPARTMENT, AIIMS JODHPUR
Jodhpur
RAJASTHAN 
7340278303

abhishekbarra2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee, AIIMS JODHPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N19||Unspecified kidney failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nurse led Respiratory muscle training.  interventional Group: Receives nurse-led respiratory muscle training in addition to standard care. Respiratory Muscle Training Exercises: Deep Breathing Exercise: Also known as diaphragmatic breathing, it engages the diaphragm to improve inhalation and exhalation efficiency. Instructions for patients: Find a comfortable, quiet place to sit or lie down. Sit with feet flat on the floor or lie on the back with a pillow under the head and knees. Place one hand on the chest and the other on the abdomen to monitor breathing patterns. Inhale slowly and deeply through the nose, focusing on expanding the abdomen rather than raising the chest. Feel the abdomen rise and the lower hand move outward while keeping the upper hand relatively still. Pause briefly after inhaling to allow for oxygen absorption and relaxation. Exhale slowly and completely through the mouth, gently contracting abdominal muscles to release air. Repeat for several minutes, aiming for a smooth, rhythmic pattern of inhalation, pause, and exhalation. Focus solely on breathing, letting go of distracting thoughts. Incentive Spirometry: Instructions for patients: Sit up straight or recline slightly in a comfortable position with feet flat on the floor and back supported. Hold the spirometer upright, ensuring the tubing is free from obstructions. Adjust the flow rate indicator to the appropriate level. Place the mouthpiece securely in the mouth, forming a tight seal with the lips. Inhale slowly and deeply through the mouthpiece, expanding the lungs as much as possible. Aim to raise the floating marker to the prescribed level on the spirometer for visual feedback. Hold the breath for 2-3 seconds at the peak of inhalation. Exhale slowly and steadily, either through the mouthpiece or normally. Perform the exercise for 20 minutes twice daily (morning and evening), with each session lasting 5 minutes and including 1 minute of rest between exercises. Implementation and Monitoring: Exercises demonstrated to patients at the hemodialysis unit. Patients to redemonstrate exercises. Patients to perform exercises at home for 20 minutes twice daily. Weekly check-ins at the hemodialysis unit for resolving doubts and reinforcing exercise continuation. Exercise Log for Participants: Participants to maintain a detailed exercise log, recording: Date Time of day Exercise type Duration Rest intervals Any variations or modifications Subjective notes on perceived exertion or comfort  
Comparator Agent  Routine care  Control group participants will receive standard routine care after hemodialysis. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients who are willing to participate in the study.
2. Patients who are receiving haemodialysis more than 3 month.
3. patients who have haemoglobin more then 8.0 mg/dl.
4. patients who understand hindi or english .  
 
ExclusionCriteria 
Details  1. Presence of an active infection or inflammatory condition
2. Occurrence of acute myocardial infarction within previous three months
3. Manifestation of symptomatic peripheral arterial disease 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Respiratory muscle strenghth   2 month  
 
Secondary Outcome  
Outcome  TimePoints 
Respiratory muscle functional capacity   2 month  
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
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)   05/09/2025 
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   Post Haemodialysis respiratory complication can be decrease by respiratory muscle training and health education. These changes can be applied more effectively if the patients involve actively in the process.
therefor a nurse led respiratory muscle training after haemodialysis in India could be used as an intensive approach to reduce the complication and improve the functional outcome.

STEP 1: Enrolment 
 The patients fulfilling the inclusion criteria in the nephrology department of selected tertiary care teaching hospital will be recruited for the present study. Informed written consent will be obtained from the patients for conducting the study, and the patients will be informed about the intervention.

 STEP 2: Baseline Data collection 
 The baseline data will be collected from the enrolled patients which will include the Socio demographic Variables, Clinical information sheet, 6 minute walk test, breath holding test , pulmonary function test , (MIP+MEP). Firstly data will be collected from the control group after completion of collection interventional group data will be collected to avoid contamination. 

 STEP 3: Non Randomization Allocation 
 Participants will be assigned into intervention and control group equally .

STEP 4: Intervention
 The control group will be given standard haemodialysis care . The interventional group will receive the nurse led respiratory muscle training along with the standard treatment which includes the following exercises: 

 ï‚· Deep breathing exercise
 Deep breathing exercises, scientifically termed diaphragmatic breathing, involve engaging the diaphragm, the primary muscle responsible for respiration, to facilitate efficient inhalation and exhalation. I will ask my patients to perform this technique: Find a comfortable, quiet place to sit or lie down. Sit in a chair with your feet flat on the floor or lie down on your back with a pillow under your head and knees for support. Place one hand on your chest and the other hand on your abdomen, just below your rib cage, to monitor your breathing patterns. Inhale slowly and deeply through your nose. As you inhale, focus on expanding your abdomen rather than raising your chest. This allows the diaphragm to descend and create more space for the lungs to fill with air. You should feel your abdomen rise and your lower hand move outward while keeping your upper hand relatively still. Once you’ve inhaled fully, pause for a moment to hold the breath. This pause allows for oxygen absorption and provides a brief moment of relaxation. Exhale slowly and completely through your mouth. As you exhale, gently contract your abdominal muscles to facilitate the release of air from the lungs. You should feel your abdomen fall and your lower hand move inward. Repeat this cycle of deep breathing for several minutes, aiming for a smooth, rhythmic pattern of inhalation, brief pause, and exhalation. As you continue with the exercise, try to focus your attention solely on your breathing, letting go of any distracting thoughts or external stimuli. 

 ï‚· Incentive Spirometary
 I will ask the patients to perform deep breathing Exercise. 
Patient will follow these steps –
 Positioning: Sit up straight or recline slightly in a comfortable position. Make sure your feet are flat on the floor or supported, and your back is well-supported. Patients will Hold the incentive spirometer upright, ensuring the tubing is free from kinks or obstructions. Adjust the flow rate indicator to the appropriate level, 
 - Place the mouthpiece securely in your mouth, forming a tight seal around it with your lips.
 - Inhale slowly and deeply through the mouthpiece, focusing on expanding your lungs as much as possible. 
- Aim to raise the floating marker or indicator to the prescribed level on the spirometer. This provides visual feedback on your inhalation effort. Hold your breath for 2-3 seconds at the peak of your inhalation, maintaining lung expansion.
 - Exhale slowly and steadily, either through the mouthpiece or normally. The exercise routine involves performing exercises for 20 minute and twice a day (morning and evening), with each session lasting 5 minutes and including 1 minute of rest between exercises. 
 Participants will be demonstrated the exercise at haemodialysis unit ask the patients to redemonstrate the exercise Patients will be asked to do Exercise at home for 20 minute twice a day . As patients will come to haemodialysis unit weekly I will resolve the doubt of the patients for exercise and reinforce the patients for the exercise continuation. 
 As part of my research investigating the efficacy of home-based exercise, participants will kindly request my participants in maintaining a detailed exercise log. Which will help in follow up of participants? I will ask my participants to record the following parameters for each exercise session: 
 1. Date 
 2. Time of Day 
 3. Exercise Type 
 4. Duration 
 5. Rest Intervals 
 6. Any Variations or Modifications 
 7. Subjective Notes on Perceived Exertion or Comfort

STEP 5: Post-intervention data collection 
 Respiratory muscle capacity and strength will be evaluated after 8 week of intervention. Respiratory muscle capacity will be assess by PFT and 6 minute walk test and respiratory muscle strength will be assess by the MIP+MEP and breath holding time. 

 STEP 6: Data analysis 
 Thereafter, collected data will be coded and entered in master sheet for analysis. Data analysis will be done with the help of SPSS 24. Descriptive and inferential statistics will be used for data analysis .

Duration of study 
The study will be completed in a period of 1 year.

 
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