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Completed

NCT Number: NCT03331458

Physical Activity in Men Newly Diagnosed With Prostate Cancer: A Feasibility Study

Recent research has indicated that physical activities incorporating moderate-intensity exercise can be safely performed during treatment and substantially reduces treatment-related side effects, such as fatigue, sleep disturbances, cognitive impairment, and nausea. However, little is known about physical activity levels prior to treatment and whether providing an exercise intervention pre-treatment may improve functional capacity during treatment.

The purpose of this study is to

1. Measure physical activity levels and functional capacity in men newly diagnosed with prostate cancer prior to treatment and 2. Explore whether a 2-week physical activity intervention is feasible during the pre-treatment timeframe:

1. Examine intervention safety and tolerance by self-report 2. Examine changes in functional capacity by 6-minute walk test 3. Examine changes in symptom experience by self-report

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Key information

Conditions

Prostate Cancer Behavior Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Motor Activity Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Duke Raleigh Cancer Center

Raleigh, North Carolina, 27606, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newly diagnosed with prostate cancer
  • will not start treatment for at least 2 weeks
  • able to read and understand English
  • capable of giving informed consent
  • at least 18 years old

Exclusion criteria

  • patients who are incompetent for interview (documented diagnosis of active psychosis or dementia)
  • unable to provide informed consent as assessed by the interviewer
  • too sick to participate, as judged by a member of the research team or the exercise physiologist
  • have been treated for another cancer

Treatment and study plan

exrecise intervention

Behavioral

Subjects will undergo pre-intervention measures, complete a daily physical activity diary, and post-intervention measures

Primary outcomes

  1. Change in 6 minute walk test

    Time frame: baseline, 2 weeks post intervention

    Distance walked in 6 minutes

  2. Change in balance test

    Time frame: baseline, 2 weeks post intervention

    Ability to balance

  3. Change in time up to go test

    Time frame: baseline, 2 weeks post intervention

    Time to get up from chair, walk 30 meters and return to sit in chair

  4. Change in Godin Leisure Time Score

    Time frame: baseline, 2 weeks post intervention

    physical activity score

  5. Change in rate of perceived exertion

    Time frame: baseline, 2 weeks post intervention

    physical exertion score

  6. Change in metabolic equivalent

    Time frame: baseline, 2 weeks post intervention

    metabolic activity score

  7. Change in distress score

    Time frame: baseline, 2 weeks post intervention

    distress score

  8. Change in self-efficacy score

    Time frame: baseline, 2 weeks post intervention

    self-efficacy score

  9. Change in symptom inventory score

    Time frame: baseline, 2 weeks post intervention

    description of symptoms

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: PACMen

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 6, 2017
Registry last updated
Aug 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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