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NCT Number: NCT07626086

Pilates Exercises on Balance, Fatigue and Quality of Life

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.

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Key information

Conditions

Renal Transplantation Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damanhour Medical National Institute, Damanhur, Beheira, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pilates exercises

Other

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

Other

Conventional physical therapy program (aerobic walking program, low intensity strengthening Exs, stretching Exs) and medical care (analgesics, antibiotics, wound care) for 12 weeks.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Kidney Disease Quality of Life self-report (KDQOL-SF)

    Time frame: 12 Weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Research Ethical Committee Faculty of Physical Therapy

CONTACT

[email protected]

01151312322

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Pilates Exercises on Balance, Fatigue and Quality of Life in Patients With Renal Transplantation

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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