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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02192216
Date of registration: 04/07/2014
Prospective Registration: No
Primary sponsor: Department of Public Health, Denmark
Public title: The Effect of Resistance Training and Aerobic Training on Body Composition During Chemotherapy
Scientific title: The Effect of Resistance Training and Aerobic Training on Body Composition During Chemotherapy
Date of first enrolment: February 2014
Target sample size: 16
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT02192216
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Denmark
Contacts
Name:     Simon Loenbro, M.Sc., PhD
Address: 
Telephone:
Email:
Affiliation:  Dept. of Public Health, Sect. for Sports Science, Aarhus University
Key inclusion & exclusion criteria

Inclusion Criteria:

- Currently receiving curative, adjuvant, neo-adjuvant or palliative chemotherapy

- No documented bone metastases or myelomatosis

- No documented CNS affection

- WHO performance status 0-1

- No chronical thrombocytopenia or leukopenia

- No physical conditions preventing exercise participation

- No serious symptoms of heart disease

- No dementia or mental illness preventing participation

- Signed written concent

- Age above 18 years

Exclusion Criteria:

- Participation in systematic resistance training three months prior to inclusion



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Neoplasms
Intervention(s)
Behavioral: Exercise
Primary Outcome(s)
Changes in body composition [Time Frame: Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).]
Secondary Outcome(s)
Changes in cancer related fatigue and quality of life [Time Frame: Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).]
Changes in aerobic performance [Time Frame: Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).]
Changes in functional performance [Time Frame: Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).]
Changes in dynamic muscle strength [Time Frame: Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).]
Changes in underlying biological mechanisms associated with changes in muscle mass [Time Frame: Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).]
Secondary ID(s)
41408
SKDM2014
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Aarhus University Hospital
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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