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Clinical Trials/NCT01749774
NCT01749774
Completed
Not Applicable

Physical Activity and Testicular Cancer - a Pilot Study: Feasibility and Effects of a Program Including Information, Counseling and a Physical Activity Program for Patients With Testicular Cancer During and After Chemotherapy

Oslo University Hospital1 site in 1 country13 target enrollmentDecember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Testicular Cancer
Sponsor
Oslo University Hospital
Enrollment
13
Locations
1
Primary Endpoint
Muscle strength, 1RM (one-repetition-maximum)
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2012
End Date
June 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Lene Thorsen

PhD

Oslo University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Muscle strength, 1RM (one-repetition-maximum)

Time Frame: 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 Outcomes

  • Cardio respiratory fitness (VO2max)(Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks))
  • 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))
  • Body composition (Lean body mass and fat mass)(Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks))
  • Work status(Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks))
  • Myoglobin(Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks))
  • C-reactive protein (CRP)(Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks))
  • Creatinkinase (CK)(Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks))
  • Anxiety and depression(Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks))
  • Quality of life(Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks))
  • Creatinkinase - MB (CK-MB)(Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks))
  • Fatigue(Baseline (0 week), post-intervention (9-12 weeks) and follow-up (24 weeks))

Study Sites (1)

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