NCT07626086

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2026

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Completed
Last Updated

June 4, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

May 27, 2026

Last Update Submit

May 31, 2026

Conditions

Keywords

Renal TransplantationBalanceFatigueQuality of LifePilates Exercises

Outcome Measures

Primary Outcomes (1)

  • 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

    12 Weeks

Secondary Outcomes (2)

  • Modified Fatigue Impact Scale

    12 Weeks

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

    12 Weeks

Study Arms (2)

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.

Other: Pilates ExercisesOther: 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.

Other: Conventional physical therapy program

Interventions

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.

Pilates exercises Plus Conventional physical therapy program.

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

Conventional physical therapy programPilates exercises Plus Conventional physical therapy program.

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Damanhour Medical National Institute

Damanhur, Beheira, 22511, Egypt

RECRUITING

Faculty of Physical Therapy

Giza, 12613, Egypt

NOT YET RECRUITING

MeSH Terms

Conditions

Fatigue

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Central Study Contacts

Research Ethical Committee Faculty of Physical Therapy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer at Department of Surgery and Burn - Faculty of Physical Therapy - Cairo University

Study Record Dates

First Submitted

May 27, 2026

First Posted

June 4, 2026

Study Start

January 1, 2026

Primary Completion

June 1, 2026

Study Completion

June 15, 2026

Last Updated

June 4, 2026

Record last verified: 2026-05

Locations