| CTRI Number |
CTRI/2025/03/083599 [Registered on: 27/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Intradialytic Stretching Exercises ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Can Stretching Exercises During Dialysis Reduce Muscle Cramps and Fatigue? A Study from a Bhopal Hospital |
|
Scientific Title of Study
|
A study to assess the effect of Intradialytic Stretching Exercises on Muscle Cramps and fatigue among Patients Undergoing Hemodialysis at tertiary care hospital Bhopal- A Randomized control 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 |
Manoj Singh Rawat |
| Designation |
M. Sc. Nursing student |
| Affiliation |
AIIMS Bhopal |
| Address |
Room No.9 Second floor, Department of Medical Surgical Nursing, Nursing College AIIMS Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8057820885 |
| Fax |
|
| Email |
manoj.mscnursing2024@aiimsbhopal.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
R Velmuruggan |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Bhopal |
| Address |
Room No.9 Second floor, Department of Medical Surgical Nursing, Nursing College AIIMS Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8010843370 |
| Fax |
|
| Email |
assistprof2.nursing@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
R Velmuruggan |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Bhopal |
| Address |
Room No.9 Second floor, Department of Medical Surgical Nursing, Nursing College AIIMS Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8010843370 |
| Fax |
|
| Email |
assistprof2.nursing@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
| All india institute of Medical Sciences Bhopal Saket Nagar Bhopal India Pincode - 462020 |
|
|
Primary Sponsor
|
| Name |
Manoj Singh Rawat |
| Address |
Room No.9 Second floor, Department of Medical Surgical Nursing, Nursing College AIIMS Bhopal India Pin code-462020 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 R Velmurugan |
AIIMS Bhopal |
10 no. block Level-3 Hemodialysis Unit, Department of Nephrology
Bhopal
MADHYA PRADESH |
8010843370
assistprof2.nursing@aiimsbhopal.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutinal Human Ethics Committee Student Research, AIIMS Bhopal |
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 |
Intradialytic Stretching Exercises |
Intervention- Intradialytic Stretching Exercise
Ankle Dorsiflexion
1.Firstly, stabilizes the lower leg just above the ankle with the non-dominant hand to prevent unintended movement.
2.With the dominant hand, gently push the top of the foot (dorsum) upward toward the shin.
3. Move the ankle through its natural range of motion (usually 10–20 degrees for dorsiflexion) without forcing the joint.
Gastrocnemius-Passive Stretch
1. Firstly, places one hand on the ball of the patient’s foot (or uses a towel/strap looped around the foot).
2. With other hand gently apply pressure, pushing the foot into dorsiflexion (towards the shin) while maintaining the knee in full extension.
3.Hold the stretch for 20–30 seconds.
Soleus-Passive Stretch
1. Firstly, places one hand and grasp the ball of the patient’s foot or use a towel/strap looped around the foot.
2. With other hand gently push the foot upward into dorsiflexion (towards the shin) while keeping the knee in a bent position.
3.Hold the stretch for 20–30 seconds, ensuring it is within a tolerable range for the patient.
Hamstring Stretch
1. Slowly lift the patient’s leg upward while keeping it straight (knee fully extended) until a gentle stretch is felt in the hamstring area (back of the thigh).
2. Stop lifting when resistance is felt or the patient reports a tolerable stretch sensation.
3. Hold the stretch for 20–30 seconds.
Quadriceps Stretch
1. Slowly bend the patient’s knee, bringing the heel towards the buttocks.
2. As the knee flexes, the quadriceps muscle will stretch.
3. Continue the movement until the patient reports a tolerable stretch or you feel resistance.
4. Hold the stretch for 20–30 seconds.
|
| Comparator Agent |
Routine treatment |
Normal saline infusion (100-200 mL bolus) for immediate relief from cramps.
Adjusting dry weight to prevent excessive fluid removal, which can trigger cramps.
Reducing ultrafiltration rate (slower fluid removal to avoid cramps).
Sodium modeling (adjusting sodium levels in dialysis fluid to prevent cramps).
Lowering dialysate temperature to reduce cramps. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.18 Years or Above.
2.Present at the time of data collection
3.Willing to participate in the Study.
4.Patients who are conscious and cooperative.
5.Patients who suffered from muscle cramps during hemodialysis.
6.Patients who are undergoing hemodialysis for 3-4 hours.
7.Patients who are undergoing hemodialysis from 4 months to 3 years.
|
|
| ExclusionCriteria |
| Details |
1.Not willing to participate.
2.Have any lower limb pathology.
3.Patients undergoing emergency and first hemodialysis.
4.Hemodynamically unstable.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Baseline levels of muscle cramps and fatigue among hemodialysis patients before intervention in both experimental and control groups.
Effect of intradialytic stretching exercises on reducing muscle cramps and fatigue among patients undergoing hemodialysis. |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Difference in muscle cramps and fatigue levels based on demographic variables (e.g., age, gender, dialysis duration).
Association between muscle cramps, fatigue, and demographic factors, identifying potential predictors of symptom severity. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/04/2025 |
| 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="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
|
This randomized controlled trial investigates the effect of Intradialytic Stretching Exercises on muscle cramps and fatigue in hemodialysis patients at a tertiary care hospital in Bhopal. A total of 60 patients are randomly assigned to experimental (exercise) and control (routine care) groups using the SNOSE method. The intervention includes structured stretching exercises (e.g., Ankle Dorsiflexion, Hamstring Stretch) performed for 20 minutes during dialysis under supervision. Muscle cramps are assessed using a self-structured Muscle Cramp Questionnaire, and fatigue is measured using the Fatigue Severity Scale (FSS). Statistical analysis includes t-tests, Chi-square tests, and ANOVA to evaluate the intervention’s effectiveness. |