Supervised Group Based Exercise for Men With Prostate Cancer on Androgen Deprivation Therapy

Prostatic Neoplasms Clinical Trial

Official title:

Supervised Group Based Exercise for Men With Prostate Cancer on Androgen Deprivation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02631681
• Other study ID #: ProstEx
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: September 2017

Study information

• Verified date: August 2019
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Exercise intervention for men with prostate cancer on androgen deprivation therapy.

Description:

The aim of the project is to investigate the effects of patient education and exercise intervention implemented in daily clinical practice for men with prostate cancer on androgen deprivation therapy

• Functional capacity

• Quality of life

• Body composition

• Blood pressure

and to assess safety of progressive resistance training for participants with bone metastases.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Androgen Deprivation Therapy
• Exercise Therapy
• Prostatic Neoplasms

Intervention

Behavioral:
• Group based exercise
Supervised group based combined aerobic and resistance training for 12 weeks as part of our normal clinical practice.

Locations

Country	Name	City	State
Denmark	Herlev and Gentofte Hospital	Herlev	Please Select An Option Below

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

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