- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07626086
Pilates Exercises on Balance, Fatigue and Quality of Life
Effect of Pilates Exercises on Balance, Fatigue and Quality of Life in Patients With Renal Transplantation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Research Ethical Committee Faculty of Physical Therapy
- Phone Number: 01151312322
- Email: eth.com@pt.cu.edu.eg
Study Locations
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Giza, Egypt, 12613
- Not yet recruiting
- Faculty of Physical Therapy
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Contact:
- Phone Number: 01151312322
- Email: eth.com@pt.cu.edu.eg
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Beheira
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Damanhur, Beheira, Egypt, 22511
- Recruiting
- Damanhour Medical National Institute
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Contact:
- MONA ZIETHAR
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
(1) Patients' age was ranged between 20-50 years old, (2) Both gender participated in this study, (3) All the patients were free from any neurological disorders, (4) All the patients were free from genitourinary infections, (5) All patients started the treatment program between 3 and 12 months following renal transplantation, (6) were not currently participating in any other regular physical exercise program, (7) Patients who were able to comprehend command and willing to participate in the study and (8) Informed consent was obtained from all patients enrolled in the trial.
Exclusion Criteria:
(1) Neuropathy issues, (2) Rheumatic diseases, (3) Orthopedic diseases, (4) Abdominal surgery of the upper or lower abdomen, (5) Patients who required acute respiratory intervention, (6) Patients who transferred to the intensive care unit, (7) Active smokers, (8) uncontrolled ABP, (9) Diabetics, (10) Chronic hepatitis, (11) Patients with pacemaker, (12) detection of reduced exercise tolerance, including tachycardia, shortness of breath, and feeling too tired or weak.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pilates exercises Plus Conventional physical therapy program.
Study group (group A) (n =25) who received Pilates exercises 3 times per week in addition to conventional physical therapy program (aerobic walking program, low intensity strengthening Exs, stretching Exs) and already taken medical care for 12 weeks.
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Pilates exercises consisted of three parts: warm-up, the main part, and relaxation.
During the warm-up phase, exercises aimed at improving respiration and increasing the range of motion were performed.
The main phase consisted of Pilates exercises for the center of force and strengthening of the articular, pelvic, trunk, and limb muscles by 13 exercises: Bridging, Hundred, Roll Up, One Leg Circle (both ways), Rocker with closed legs, Single Straight Leg Stretch, Double Leg Stretch, Spine Stretch Forward, Single Leg Kick, Side Kick up and down, Side Kick circles, Rest position (stretch and relaxation), and Curling.
During the relaxation phase, stretching, relaxation, and breathing exercises were performed 3 times per week for 12 weeks.
Conventional physical therapy program (aerobic walking program, low intensity strengthening Exs, stretching Exs) and medical care (analgesics, antibiotics, wound care) for 12 weeks.
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Experimental: Conventional physical therapy program
Control group (group B) (n =25) who received conventional physical therapy program (aerobic walking program, low intensity strengthening Exs, stretching Exs) and medical care for 12 weeks.
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Conventional physical therapy program (aerobic walking program, low intensity strengthening Exs, stretching Exs) and medical care (analgesics, antibiotics, wound care) for 12 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Borg Balance Scale
Time Frame: 12 Weeks
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The Berg Balance Scale, possibly the most widely used balance-related measure, has gained popularity in clinical trials.
It provides information about patients' balance-related abilities and can be used to assess improvement or worsening after rehabilitation.
The BBS is a scale that includes scoring between 0 (not applicable) and 4 (normal performance) for the performance of 14 different tasks.
Scores from 0 to 20 indicate a loss of balance, scores from 21 to 40 suggest an acceptable level of balance, and scores from 41 to 56 indicate good balance on this scale, which is examined across 56 points
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12 Weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Fatigue Impact Scale
Time Frame: 12 Weeks
|
Fatigue impact was assessed using the self-report Modified Fatigue Impact Scale (MFIS), which comprises a total score MFIS Total and three subscales (MFIS Physical, MFIS Cognitive and MFIS Psychosocial).
Higher scores indicate more fatigue impact.
The MFIS Total score (available range 0 - 84) was dichotomized at 38 to create two categories of participants, fatigued and non-fatigued
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12 Weeks
|
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Kidney Disease Quality of Life self-report (KDQOL-SF)
Time Frame: 12 Weeks
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This questionnaire is used to assess the QOL of patients with kidney disease, It contains twenty-four questions covering a wide range of domains of human functioning in daily, occupational and social life.
It is a self-report measure, resulting from a subjective perception of one's health, functionality, and their QOL as directly related to having kidney disease.
Each answer in the questionnaire is assigned a specific number of points.
The scoring of answers in the KDQoL-SFTM questionnaire is carried out using a scale from 0 to 100 points.
The higher the value, the higher the QOL, and the lower the value, the worse the QOL.
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12 Weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 752017
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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