Renal TransplantationNCT07626086
Pilates Exercises on Balance, Fatigue and Quality of Life
A study testing Pilates Exercises and Conventional physical therapy program in people with Renal Transplantation, run by Cairo University at 2 sites in Egypt.
Trial summary
Fifty patients of both genders with age 20- 50 year old suffering from physical and functional limitations after renal transplantation surgeries participated in this study. The participants were randomly distributed into two groups equal in number. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- Pilates Exercises and Conventional physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2026to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Damanhour Medical National Institute
Damanhur, Beheira, 22511
MONA ZIETHAR
- Not yet recruiting
Faculty of Physical Therapy
Giza, 12613
01151312322, eth.com@pt.cu.edu.eg
About this study
Official title: Effect of Pilates Exercises on Balance, Fatigue and Quality of Life in Patients With Renal Transplantation
Fifty patients of both genders with age 20- 50 year old suffering from physical and functional limitations after renal transplantation surgeries participated in this study. The participants were randomly distributed into two groups equal in number. Group (A): 25 patients who received Pilates exercises 3 times per week in addition to conventional physical therapy program with medical care for 12 weeks while control group (group B) (n =25) who received conventional physical therapy program with medical care for 12 weeks.
Read the detailed description
Fifty patients of both genders with age 20- 50 year old suffering from physical and functional limitations after renal transplantation surgeries participated in this study. The participants were selected from Damanhour Medical National Institute and randomly distributed into two groups equal in number. Group (A): 25 patients who received Pilates exercises 3 times per week in addition to conventional physical therapy program with medical care for 12 weeks while control group (group B) (n =25) who received conventional physical therapy program with medical care for 12 weeks. Outcome measures were balance, fatigue and quality of life. Balance was evaluated by Borg Balance Scale; Fatigue was evaluated by Modified Fatigue Impact Scale and Quality of Life was evaluated by Kidney Disease Quality of Life self-report (KDQOL-SF), before and after the intervention.
- Conditions
- Renal Transplantation
- Being tested
- Pilates Exercises, Conventional physical therapy program
- Keywords
- Renal Transplantation, Balance, Fatigue, Quality of Life, Pilates Exercises
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates ExercisesOther
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 programOther
Conventional physical therapy program (aerobic walking program, low intensity strengthening Exs, stretching Exs) and medical care (analgesics, antibiotics, wound care) for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pilates exercises Plus Conventional physical therapy program. | Experimental | 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. Receives: Other: Pilates Exercises; Other: Conventional physical therapy program |
| Conventional physical therapy program | Experimental | 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. Receives: Other: Conventional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Borg Balance Scale
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
Measured: 12 Weeks
Secondary outcomes (2)
Modified Fatigue Impact Scale
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
Measured: 12 Weeks
Kidney Disease Quality of Life self-report (KDQOL-SF)
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.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Jan 2026
- Primary completion1 Jun 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mohamed Amin Ziethar, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626086
- Sponsor's protocol ID
- 752017
- Status last verified
- May 2026
- First submitted
- 27 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pilates Exercises on Balance, Fatigue and Quality of Life in Patients With Renal Transplantation
- ClinicalTrials.gov ID
- NCT07626086
- Acronym / sponsor ID
- 752017
- Conditions
- Renal Transplantation
- Keywords
- Renal Transplantation, Balance, Fatigue, Quality of Life, Pilates Exercises
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fifty patients of both genders with age 20- 50 year old suffering from physical and functional limitations after renal transplantation surgeries participated in this study. The participants were randomly distributed into two groups equal in number. Group (A): 25 patients who received Pilates exercises 3 times per week in addition to conventional physical therapy program with medical care for 12 weeks while control group (group B) (n =25) who received conventional physical therapy program with medical care for 12 weeks.
Detailed description
Fifty patients of both genders with age 20- 50 year old suffering from physical and functional limitations after renal transplantation surgeries participated in this study. The participants were selected from Damanhour Medical National Institute and randomly distributed into two groups equal in number. Group (A): 25 patients who received Pilates exercises 3 times per week in addition to conventional physical therapy program with medical care for 12 weeks while control group (group B) (n =25) who received conventional physical therapy program with medical care for 12 weeks. Outcome measures were balance, fatigue and quality of life. Balance was evaluated by Borg Balance Scale; Fatigue was evaluated by Modified Fatigue Impact Scale and Quality of Life was evaluated by Kidney Disease Quality of Life self-report (KDQOL-SF), before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates exercises Plus Conventional physical therapy program. | Experimental | Other: Pilates Exercises, Other: Conventional physical therapy programStudy 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. |
| Conventional physical therapy program | Experimental | Other: Conventional physical therapy programControl 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilates ExercisesPilates 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. | Other | Pilates exercises Plus Conventional physical therapy program. |
| Conventional physical therapy programConventional physical therapy program (aerobic walking program, low intensity strengthening Exs, stretching Exs) and medical care (analgesics, antibiotics, wound care) for 12 weeks. | Other | Conventional physical therapy program, Pilates exercises Plus Conventional physical therapy program. |
Primary outcome
Borg Balance Scale
Time frame: 12 Weeks
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
2 secondary outcomes
Modified Fatigue Impact Scale
Time frame: 12 Weeks
Kidney Disease Quality of Life self-report (KDQOL-SF)
Time frame: 12 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates Exercises and Conventional physical therapy program in people with Renal Transplantation, run by Cairo University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Ethical Committee Faculty of Physical Therapy (01151312322, eth.com@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Borg Balance Scale (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.