Study Results
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Basic Information
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TERMINATED
NA
19 participants
INTERVENTIONAL
2015-11-30
2016-11-30
Brief Summary
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Detailed Description
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The present study is a randomized controlled trial comparing a tailored exercise program consisting of aerobic and strength training during chemotherapy to a control group receiving one individual lifestyle counseling session during the first chemotherapy cycle. The TC patients will be included and assessed before the first cycle of chemotherapy and further assigned to either a exercise group or a control group. The intervention will last for 9 or 12 weeks (depending on the number of bleomycin, etoposide, cisplatin (BEP)/etoposide, cisplatin (EP) cycles received) and it will consists of two-three one-hour sessions per week mostly supervised by a personal trainer. All variables will be assessed pre- and post-intervention, and at three and 12 months follow-up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Exercise group
Aerobic- and Strength Training program
Exercise group
The intervention will be conducted during chemotherapy and tailored for each patient. The program will include 1) weight bearing aerobic exercises to maintain the oxygen transport and thereby reduce the decline in VO2max during chemotherapy and 2) strength training exercises to maintain muscle mass and muscle strength. The intervention will last for 9 or 12 weeks, depending on the number of BEP/EP cycles received. The program will consist of two-three one-hour exercise sessions per week, of which most supervised by a personal trainer. The intensity of each exercise sessions will varies from easy (warm-up: 60-70 % of peak heart rate) to moderate/high (between aerobic intervals 60-70% of peak heart rate and during aerobic intervals 85-95 %).
Control group
One lifestyle counseling session
Control group
The control group will receive one individual lifestyle counseling session during the first chemotherapy cycle and can perform all activities that they have planned to do during chemotherapy.
Interventions
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Exercise group
The intervention will be conducted during chemotherapy and tailored for each patient. The program will include 1) weight bearing aerobic exercises to maintain the oxygen transport and thereby reduce the decline in VO2max during chemotherapy and 2) strength training exercises to maintain muscle mass and muscle strength. The intervention will last for 9 or 12 weeks, depending on the number of BEP/EP cycles received. The program will consist of two-three one-hour exercise sessions per week, of which most supervised by a personal trainer. The intensity of each exercise sessions will varies from easy (warm-up: 60-70 % of peak heart rate) to moderate/high (between aerobic intervals 60-70% of peak heart rate and during aerobic intervals 85-95 %).
Control group
The control group will receive one individual lifestyle counseling session during the first chemotherapy cycle and can perform all activities that they have planned to do during chemotherapy.
Eligibility Criteria
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Inclusion Criteria
* stage II-IV
* referred to chemotherapy (3-4 BEP (bleomycin, etoposide and cisplatin)-cycles or 4 EP (etoposide and cisplatin) -cycles) with/without retroperitoneal lymph node dissection (RPLND)
* satisfactory Norwegian Language skills
* signed informed consent
Exclusion Criteria
* heart and lung diseases that contraindicate exercise testing and the supervised exercise program without adjusted actions according to American College of Sports Medicine (ACSM)'s guidelines)
* physical and mental conditions of a severity that complicates the ability for exercise testing and the supervised exercise program
18 Years
60 Years
MALE
No
Sponsors
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Norwegian School of Sport Sciences
OTHER
Oslo University Hospital
OTHER
Responsible Party
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Lene Thorsen
PhD
Principal Investigators
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Lene Thorsen, PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Locations
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Oslo University Hospital
Oslo, , Norway
Countries
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References
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Thorsen L, Haugnes HS, Fossa SD, Brydoy M, Tandstad T, Wisloff T, Gjerset GM, Edvardsen E, Larsen KO, Sandset PM, Henriksson CE, Raastad T, Negaard HFS. Thromboembolic events after high-intensity training during cisplatin-based chemotherapy for testicular cancer: Case reports and review of the literature. Int J Cancer. 2020 Dec 1;147(11):3189-3198. doi: 10.1002/ijc.33151. Epub 2020 Jul 1.
Other Identifiers
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REK - 2014/1169
Identifier Type: -
Identifier Source: org_study_id
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