Optimal Timing of Physical Activity in Cancer Treatment (ACT)
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|ClinicalTrials.gov Identifier: NCT01642680|
Recruitment Status : Recruiting
First Posted : July 17, 2012
Last Update Posted : April 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome Vascular Disorders Cardiovascular Risk Factors Fatigue||Other: A tailored physical activity program during chemotherapy Other: A tailored physical activity program after chemotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||206 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optimal Timing of a Tailored Physical Activity Program During Chemotherapeutic Cancer Treatment to Reduce Long-term Cardiovascular Morbidity|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2018|
Experimental: Physical activity during chemotherapy
This group will start with a physical activity program 3 months before the end of their chemotherapeutic regimen. After chemotherapy they will continue the PA program for another 3 months.
Other: A tailored physical activity program during chemotherapy
The early group will start the PA program during chemotherapy for 3 months, and after completion of chemotherapy for 3 months (total 6 months). The PA program will consist of two components: improvement of physical fitness and empowerment to adopt a healthy lifestyle. Longitudinal effects of this PA program will be evaluated at 5 time points: before chemotherapy; at start of the PA program and at 3, 6 and 18 months after start of the PA program. Safety parameters will be monitored throughout the study period.
Active Comparator: Physical activity after chemotherapy
This group will start with a physical activity program after the end of their chemotherapeutic regimen. The physical activity program wil take 6 months to complete.
Other: A tailored physical activity program after chemotherapy
The late group will start the PA program after completion of the chemotherapy for 6 months. The PA program will consist of two components: improvement of physical fitness and empowerment to adopt a healthy lifestyle. Longitudinal effects of this PA program will be evaluated at 5 time points: before chemotherapy; at start of the PA program and at 3, 6 and 18 months after start of the PA program. Safety parameters will be monitored throughout the study period.
- Difference in VO2 max between the groups after completion of the PA program. [ Time Frame: 1 year ]The aim of this study is investigate whether a tailored PA program that starts early (during curative chemotherapy with cardiovascular toxic potential) is superior in terms of reducing long-term cancer-treatment-related metabolic syndrome and cardiovascular morbidity to a program that starts late (after completion of chemotherapy).
- Muscle strength [ Time Frame: 1 year ]
- change in metabolic and cardiovascular damage parameters [ Time Frame: 1 year ]
- cardiovascular risk factors and quality of life including self-efficacy [ Time Frame: 1 year ]
- fatigue and physical activity level [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01642680
|Contact: Annemiek Walenkamp, MD, PhD||+31 (0)50 firstname.lastname@example.org|
|Contact: Jourik Gietema, MD, PhD||+31 (0)50 email@example.com|
|University Medical Centre Groningen||Recruiting|
|Groningen, Netherlands, 9713GZ|
|Principal Investigator: Annemiek ME Walenkamp, MD, PHD|
|Principal Investigator: Jourik A Gietema, MD, PhD|
|Principal Investigator: Ellen van Weert, PhD|
|Sub-Investigator: Nico-Derk L Westerink, MD|
|Principal Investigator:||Annemiek Walenkamp, PhD||University Medical Center Groningen|