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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01669109
Other study ID # 12-4957-BO
Secondary ID
Status Completed
Phase N/A
First received August 16, 2012
Last updated January 9, 2014
Start date September 2012
Est. completion date December 2013

Study information

Verified date January 2014
Source Universität Duisburg-Essen
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

Hatha Yoga is a traditional practice that encompasses aerobic exercise, breathing techniques, and meditation. It is used in India since centuries to improve well-being and cope with diseases and is gaining more and more interest in Europe and the US. While studies have demonstrated benefits of Hatha Yoga for patients with breast cancer, no studies on patients with colorectal cancer are available yet. The purpose of this study is to investigate the effect of Hatha Yoga in patients with colorectal cancer.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Colorectal cancer

- UICC stage I-III

- between 2 and 48 months post-surgery

- age at least 18 years

- physical and cognitive ability to follow the yoga intervention

Exclusion Criteria:

- UICC stage IV

- further active oncological diseases

- diagnosed and pharmacologically treated psychiatric disorder except for cancer-related depression or adjustment disorder

- pregnancy or breastfeeding

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Hatha yoga


Locations

Country Name City State
Germany Department of Internal and Complementary Medicine, Immanuel Hospital Berlin Berlin
Germany Department for Internal and Integrative Medicine, Essen-Mitte Clinics Essen

Sponsors (1)

Lead Sponsor Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Body awareness/bodily dissociation Scale of Body Connection (SBC)
Used in mediation analysis
Week 10, week 22 No
Other Body efficacy expectation Body Efficacy-Expectation Scale
Used in mediation analysis
Week 10, week 22 No
Other Qualitative Interviews Week 11 No
Primary Health-related quality of life Functional Assessment of Cancer Therapy - Colorectal Cancer (FACT-C) Week 10 No
Secondary Health-related quality of life - Functional Assessment of Cancer Therapy - Colorectal Cancer (FACT-C) Week 22 No
Secondary Fatigue Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Week 10, week 22 No
Secondary Anxiety, depression Hospital Anxiety and Depression Scale (HADS) Week 10, week 22 No
Secondary Sleep quality Pittsburgh Sleep Quality Index (PSQI) Week 10, week 22 No
Secondary Safety Number and severity of adverse events Week 0-22 Yes
Secondary Spiritual well-being - Functional Assessment of Chronic Illness Therapy - Spirituality (FACIT-Sp) Week 10, week 22 No
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