- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07709429
Qigong Exercise for Muscles Strength and Quality of Life in Colorectal Cancer Patients Undergoing Chemotherapy
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Muscle weakness and fatigue are prevalent side effects experienced by patients undergoing chemotherapy for colorectal cancer. These symptoms can significantly impact daily functioning and overall quality of life. Finding effective treatments for this condition is crucial to improving patient outcomes and quality of life.
Qigong serves as a holistic exercise modality that not only strengthens muscles but also elevates the overall quality of life. Its gentle movements make it accessible to a wide range of individuals, including those undergoing rehabilitation or managing chronic health issues.
Furthermore the need of this study is developed from lack in the quantitative knowledge and information in the published studies about the effect of Qigong on muscle strength and quality of life in colorectal cancer patients undergoing chemotherapy.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Shrouk Mohamed Reda Abd Elaliem, M.Sc
- Telefonní číslo: +20 12 71384571
- E-mail: Shorouq.mohamed@nub.edu.eg
Studijní záloha kontaktů
- Jméno: Khadra Mohammed Ali, PhD
Studijní místa
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Giza, Egypt
- Faculty of Physical Therapy, Cairo University
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Kontakt:
- Shrouk Mohamed Reda Abd Elaliem, M.Sc
- Telefonní číslo: +20 12 71384571
- E-mail: Shorouq.mohamed@nub.edu.eg
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Age ranges between 35 and 55 years.
- Male & female patients will participate in the study.
- All patients with colorectal cancer undergoing chemotherapy.
- All patients enrolled to the study will have their informed consent.
- The patients will be instructed to report any side effects during the management.
Exclusion Criteria:
- Presence Patients with psychological disturbance or mental illness.
- Cardiopulmonary disease.
- Hypotensive patients.
- Nerve, muscle, or joint disease, or other malignant tumors affecting movement.
- Autoimmune disease.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Qigong Exercise + Conventional Exercise Program
Participants will receive a supervised Baduanjin Qigong exercise program combined with conventional exercises, including pain-free range-of-motion exercises, low-intensity walking, and physical therapy education.
The intervention will be conducted three times weekly for 12 weeks under physiotherapist supervision, while participants continue their prescribed chemotherapy and routine medical follow-up.
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Participants will receive a supervised Baduanjin Qigong exercise program combined with conventional exercises, including pain-free range-of-motion exercises, low-intensity walking, and physical therapy education.
The intervention will be conducted three times weekly for 12 weeks under physiotherapist supervision, while participants continue their prescribed chemotherapy and routine medical follow-up.
Participants in this arm will receive a conventional exercise program consisting of pain-free range-of-motion exercises for the shoulder, elbow, wrist, hip, knee, and ankle joints, low-intensity walking, and physical therapy education to maintain daily activities.
The intervention will be administered for 12 weeks, with three sessions per week.
Participants will continue their prescribed chemotherapy and routine outpatient medical follow-up throughout the study and will not participate in any additional structured exercise program during the intervention period.
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Aktivní komparátor: Conventional Exercise Program
Participants in this arm will receive a conventional exercise program consisting of pain-free range-of-motion exercises for the shoulder, elbow, wrist, hip, knee, and ankle joints, low-intensity walking, and physical therapy education to maintain daily activities.
The intervention will be administered for 12 weeks, with three sessions per week.
Participants will continue their prescribed chemotherapy and routine outpatient medical follow-up throughout the study and will not participate in any additional structured exercise program during the intervention period.
|
Participants in this arm will receive a conventional exercise program consisting of pain-free range-of-motion exercises for the shoulder, elbow, wrist, hip, knee, and ankle joints, low-intensity walking, and physical therapy education to maintain daily activities.
The intervention will be administered for 12 weeks, with three sessions per week.
Participants will continue their prescribed chemotherapy and routine outpatient medical follow-up throughout the study and will not participate in any additional structured exercise program during the intervention period.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Muscle Strength
Časové okno: 12 weeks
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Muscle strength of the upper and lower limbs will be assessed using the Lafayette Hand-Held Dynamometer.
Muscle strength will be quantified as the maximum isometric force generated by the tested muscle groups, with higher values indicating greater muscle strength.
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12 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Health-Related Quality of Life
Časové okno: 12 weeks
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Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36).
The questionnaire evaluates multiple domains of physical and mental health, with domain scores ranging from 0 to 100.
Higher scores indicate better health-related quality of life.
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12 weeks
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Studijní židle: Amal Mohammed Abd El Baky, PhD, Professor, Cairo University
- Ředitel studie: Khadra Mohammed Ali, PhD, Assist Professor, Cairo University
- Ředitel studie: Eid Rizk El Gamal, PhD, Assist. Professor, Al-Azhar University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- P.T.REC/012/005843
Informace o lécích a zařízeních, studijní dokumenty
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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