Physical Activity and Testicular Cancer

Not Applicable

Completed

• Conditions: Testicular Cancer
• Interventions: Behavioral: Physical activity counseling

• Registration Number: NCT01749774
• Lead Sponsor: Oslo University Hospital

Brief Summary

The purpose of this study is to determine the feasibility and effect of a program including information, counseling and an individualized physical activity program on physical and psychological health during and after chemotherapy in patients with testicular cancer. It is hypothesized that the patients are able to complete the intervention with individual adjustments.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-30
• Study Start: 2012-12
• Study First Submitted QC: 2012-12-12
• Study First Posted: 2012-12-17
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-15
• Last Update Posted: 2014-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 13

Inclusion Criteria

• Seminoma/non-seminoma
• Stage II-IV
• 3-4 BEP(bleomycin,etoposide and cisplatin)or 4 EP(etoposide and cisplatin)
• > 18 years
• Capable of reading and writing Norwegian

Exclusion Criteria

• Conditions of a severity that contraindicate exercise without adjusted actions
• Mentally incompetent conditions
• Conditions of a severity that complicates the ability to participate in a supervised training program

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Physical activity counseling	Physical activity counseling	-

Primary Outcome Measures

Name	Time	Method
Muscle strength, 1RM (one-repetition-maximum)	Baseline (0 weeks), post-intervention (9-12 weeks) and follow-up (24 weeks)	Change in 1RM from baseline to post-intervention and follow-up

Secondary Outcome Measures

Name	Time	Method
Cardio respiratory fitness (VO2max)	Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)	Change in VO2max from baseline to post-intervention and follow-up
Metabolic disease markers (blood pressure, body mass index, glucose, high density lipoprotein cholesterol, triglycerides)	Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)	Change in metabolic disease markers from baseline to post-intervention and follow-up
Body composition (Lean body mass and fat mass)	Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)	Change in body composition from baseline to post-intervention and follow-up
Work status	Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)	Change in work status from baseline to post-intervention and follow-up
Myoglobin	Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)	Change in myoglobin from baseline to post-intervention and follow-up
C-reactive protein (CRP)	Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)	Change in CRP from baseline to post-intervention and follow-up
Creatinkinase (CK)	Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)	Change in CK from baseline to post-intervention and follow-up
Anxiety and depression	Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)	Change in anxiety and depression from baseline to post-intervention and follow-up
Quality of life	Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)	Change in quality of life from baseline to post-intervention and follow-up
Creatinkinase - MB (CK-MB)	Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)	Change in CK-MB from baseline to post-intervention and follow-up
Fatigue	Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks)	Change in fatigue from baseline to post-intervention and follow-up

Trial Locations

Locations (1)

Oslo university hospital; 🇳🇴 Oslo, Norway