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SUPERvised Three-month Exercise Program in MEN With Prostate cAncer Receiving Androgen-deprivaTioN thERapy (Superman)

C

Canisius-Wilhelmina Hospital

Status

Suspended

Conditions

Metastasis
Prostatic Neoplasms

Treatments

Other: Physiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06282185
CanisiusWH

Details and patient eligibility

About

The goal of this single blind placebo-controlled intervention study is to examine the impact of a supervised training program on disease-related quality of life and physical fitness in patient with advanced prostate cancer compared to usual care. The main question[s] it aims to answer are:

  • What is the impact of exercise on quality of life
  • What is the impact of exercise on physical fitness

Participants will have an individual training program with supervised training by physiotherapists.

Researchers will compare with usual care to see if advice about exercise has significant less effect than an supervised training program.

Enrollment

20 estimated patients

Sex

Male

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Signed informed consent
  • Age > 18 years old
  • Able to read and complete questionnaires in Dutch
  • Proven histologically and /or radiologically metastatic prostate cancer (TxNxM1)

Exclusion criteria

  • Other cancers
  • Clinicians' judgement
  • Age >80 years old or not able to walk 400m
  • Structural exercise (moderate-intensity exercise more than 150 minutes a week) during the past 3 months
  • Musculoskeletal, cardiovascular, or neurological disorders that could inhibit them from exercising
  • Spinal cord compression, history of pathological fractures

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 2 patient groups

intervention
Experimental group
Description:
supervised training program for twelve weeks + usual care + advice about exercise
Treatment:
Other: Physiotherapy
usual care
No Intervention group
Description:
usual care + advice about exercise

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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