- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Research Ethical Committee Faculty of Physical Therapy
- Telefonnummer: 01151312322
- E-Mail: eth.com@pt.cu.edu.eg
Studienorte
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Giza, Ägypten, 12613
- Noch keine Rekrutierung
- Faculty of physical therapy
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Kontakt:
- Telefonnummer: 01151312322
- E-Mail: eth.com@pt.cu.edu.eg
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Beheira
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Damanhur, Beheira, Ägypten, 22511
- Rekrutierung
- Damanhour Medical National Institute
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Kontakt:
- MONA ZIETHAR
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Borg Balance Scale
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Modified Fatigue Impact Scale
Zeitfenster: 12 Weeks
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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)
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 752017
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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