- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07370662
Effect of Resistance Exercises and Relaxation Therapy on Physical Function and Quality Of Life in Patients With Chronic Kidney Disease
The significance of this study to compare the effect of resistance exercises and relaxation therapy to find out which technique is more effective for improving physical function and quality of life in chronic kidney disease patient.
The study was aimed to determine the effect of resistance exercises and relaxation therapy on physical function and quality of life in patients with chronic kidney disease.
We hypothesized if there was significant effect of resistance exercises and relaxation therapy on physical function and quality of life in patients with chronic kidney disease.
Group A: Relaxation therapy and Resistance exercises. Group B: Resistance exercises.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chronic kidney disease (CKD) is a pathophysiological process, where the kidneys experience a slow, progressive and irreversible decline in function where the body's ability fail in maintaining metabolism and fluid and electrolyte balance causes the occurrence of uremia.
Individuals of all ages and both sexes benefit from moderate-intensity physical activity, with diminished risk of cardiovascular diseases, maintenance of muscle strength, fewer symptoms of depression and anxiety and improved quality of life. Resistance exercises, alone and in combination with other exercises have shown beneficial outcomes in improving physical fitness, walking capacity, cardiovascular outcomes, and health-related quality of life (HRQoL). However, relaxation techniques are considered successful in improving the condition of patients. Deep breathing relaxation techniques can reduce oxidative stress, increase cellular energy, increase elasticity of blood vessels and improve circulation, so that the final result can reduce and even overcome fatigue. The technique is easy to do, easy to learn, does not harm and a less costs is the advantage of deep breathing relaxation techniques. Resistance training has been successfully recommended as a method of gaining lean mass, strength and physical functioning in frail elderly persons and those with chronic diseases, including patients with cardiovascular and kidney diseases
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Arif Memorial Teaching Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age (30-65years).
- Both Male and female.
- Patient able to stand and walk independently.
- Patient with mild to moderate stage of chronic kidney disease.
Exclusion Criteria:
- Physical disability.
- Acute Myocardial infarction.
- Kidney transplant.
- Pregnant women.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Resistance exercises
Resistance exercise (knee and hip flexion and extension ,and elbow extension)
|
The researcher taught patients this exercise and encouraged them to do it daily each once about 20 to 30 minutes.
The exercise started with moderate intensity of no more than 10 minutes then time of practice increased gradually to 30 minutes.
Resistance exercise included the following: Knee and hip flexion and extension, elbow extension.
The repetition was be 15-20 times
|
|
Experimental: Relaxation exercise
Diaphragmatic Breathing + Pursed Lip Breathing
|
The researcher taught patients this exercise and encouraged them to do it daily each once about 20 to 30 minutes.
The exercise started with moderate intensity of no more than 10 minutes then time of practice increased gradually to 30 minutes.
Resistance exercise included the following: Knee and hip flexion and extension, elbow extension.
The repetition was be 15-20 times
Relaxation exercise (diaphragmatic breathing, pursed lip breathing) Diaphragmatic breathing is intended to help patient use the diaphragm correctly while breathing to strengthen the diaphragm and decrease the work of breathing.
Patient was instructed to sit comfortably with the knees bent and the shoulders, head and neck relaxed.
Breathe in slowly through the nose so that the stomach moves out against the hand.
Then exhaled through pursed lib technique so that stomach moves in again.
Patients was instructed to place one hand on the upper chest and the other just below the rib cage.
This was allowing patient to feel the diaphragm move as he or she breathe.
Patients was instructed to practice this exercise 5-10 minutes about 3-4 times per day.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SF 36 (Quality of Life)
Time Frame: Pre-test (Baseline) and Post-test (08 Weeks)
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To assess patients Quality of life SF-36 was used.
It provides information on 8 scales, scoring from0(worst health) to100(best health), and on the physical component scale (PCS) and the mental component scale (MCS), normalized scores representing overall physical and mental functioning
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Pre-test (Baseline) and Post-test (08 Weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sit-to-Stand test
Time Frame: Pre-test (Baseline) and Post-test (08 Weeks)
|
The STS 10 consisted of measuring the seconds employed by the patient to stand up from the sitting position, and to sit down for 10 consecutive times as quickly as possible.
STS-10 is proved to be a feasible measure to detect changes resulting from an exercise intervention [ After 5 minutes for recuperation, the patient performed the STS 60 consisting of standing-up from a chair and sitting-down again as many times as possible during a 60 second time period.
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Pre-test (Baseline) and Post-test (08 Weeks)
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6-minute walk test
Time Frame: Pre-test (Baseline) and Post-test (08 Weeks)
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It was used as an indicator of patients' exercise capacity.
The total distance covered by subjects during 6 minutes on a walk of 20 meters in length along an internal corridor of the HD unit was recorded
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Pre-test (Baseline) and Post-test (08 Weeks)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Segura-Ortí E, Kouidi E, Lisón J. Effect of resistance exercise during hemodialysis on physical function and quality of life: randomized controlled trial. Clinical nephrology. 2009;71(5):527.
- Barcellos FC, Santos IS, Mielke GI, Del Vecchio FB, Hallal PC. Effects of exercise on kidney function among non-diabetic patients with hypertension and renal disease: randomized controlled trial. BMC nephrology. 2012;13:1-7.
- Abd Elbaky M, Zaki S, Amin N, Ali R. Impact of Intradialytic Rehabilitation Program on General Health of Chronic Kidney Disease Patients. American Journal of Nursing. 2018;6(5):263-72
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Pathological Conditions, Signs and Symptoms
- Renal Insufficiency, Chronic
Other Study ID Numbers
- IRB/2024/159
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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