- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07709429
Qigong Exercise for Muscles Strength and Quality of Life in Colorectal Cancer Patients Undergoing Chemotherapy
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Shrouk Mohamed Reda Abd Elaliem, M.Sc
- Telefonnummer: +20 12 71384571
- E-post: Shorouq.mohamed@nub.edu.eg
Studer Kontakt Backup
- Navn: Khadra Mohammed Ali, PhD
Studiesteder
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Giza, Egypt
- Faculty of Physical Therapy, Cairo University
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Ta kontakt med:
- Shrouk Mohamed Reda Abd Elaliem, M.Sc
- Telefonnummer: +20 12 71384571
- E-post: Shorouq.mohamed@nub.edu.eg
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Aktiv komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Muscle Strength
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Health-Related Quality of Life
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Amal Mohammed Abd El Baky, PhD, Professor, Cairo University
- Studieleder: Khadra Mohammed Ali, PhD, Assist Professor, Cairo University
- Studieleder: Eid Rizk El Gamal, PhD, Assist. Professor, Al-Azhar University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P.T.REC/012/005843
Legemiddel- og utstyrsinformasjon, studiedokumenter
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