Prostatic Neoplasms Clinical Trial
Official title:
Supervised Group Based Exercise for Men With Prostate Cancer on Androgen Deprivation Therapy
NCT number | NCT02631681 |
Other study ID # | ProstEx |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2014 |
Est. completion date | September 2017 |
Verified date | August 2019 |
Source | Herlev Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Exercise intervention for men with prostate cancer on androgen deprivation therapy.
Status | Completed |
Enrollment | 200 |
Est. completion date | September 2017 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with a prostate cancer diagnosis on androgen deprivation therapy Exclusion Criteria: - Opioid demanding treatment for skeletal pain - Eastern Cooperative Oncology Group performance status > 2 - Inability to perform floor and machine exercises independently |
Country | Name | City | State |
---|---|---|---|
Denmark | Herlev and Gentofte Hospital | Herlev | Please Select An Option Below |
Lead Sponsor | Collaborator |
---|---|
Herlev Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in 30second Chair-Stand test (30s-CST) | Test of functional capacity, measured as change | Baseline, 12 and 24 weeks | |
Primary | Change in Graded Cycling Test with Talk Test (GCT-TT) | Test of functional capacity, measured as change | Baseline, 12 and 24 weeks | |
Secondary | change in QoL | European Organisation for Research and Treatment of Cancer (EORTC) cancer and prostate specific questionnaires: EORTC QLQC-30 version 3.0 and PR25 | Baseline, 12 and 24 weeks | |
Secondary | change in Body composition | BMI, waist and hip circumference, waist-hip ratio. | Baseline, 12 and 24 weeks | |
Secondary | change in Bloodpressure | Systolic and diastolic bloodpressure | Baseline, 12 and 24 weeks | |
Secondary | Safety of exercise assessed by serious adverse events according to the FDA | Study period baseline - 24 weeks | ||
Secondary | Compliance assessed by attendance and continued exercise (yes/no) | Baseline, 12 and 24 weeks |
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