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Completed

NCT Number: NCT05064670

Exercise as Medicine for People With Cancer Sweden

Regular exercise has been shown to have beneficial health effects in cancer survivors, including improving quality of life and other important health outcomes. However, providing people with cancer with easily accessible, high-quality exercise support and programs is a challenge. Therefore, there is a need to develop easily accessible exercise programs that draw upon the current evidence. Supervised, distance-based exercise programs have the benefit of reaching out to many people while providing the support of an exercise professional.

The aim of the EX-MED Cancer Sweden trial is to examine the effectiveness of a supervised, distance-based exercise program, in people previously treated for breast, prostate, or colorectal cancer, on health-related quality of life (HRQoL), as well as other physiological and patient-reported health outcomes. Participants will be randomized to a 3-month supervised, distance-based exercise program or to a usual care control group.

Testing timepoints are baseline, 3 months (end of intervention) and 6 months (3 month followup). At these timepoints, patients will be asked to fill in online questionaires, and and undergo physical tests. A selection of the particpants and personal trainers involved in the intervention will also be invited to participate in focus group discussion or interviews about the experiences of being involved in the EX-MED Cancer Sweden program.

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Key information

Conditions

Prostate Cancer Behavior Breast Cancer Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Intestinal Diseases Intestinal Neoplasms Male Urogenital Diseases Motor Activity Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Rectal Diseases Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institute/ Karolinska University Hospital

Stockholm, Sweden

About this study

The primary aim of the study is to examine the effectiveness of EX-MED Cancer Sweden on health-related quality of life in people diagnosed with breast, prostate, and colorectal cancer.

The secondary aims are to examine the effect of the program on other important endpoints such as physical activity level, physical function, muscle strength, exercise capacity, symptoms, and body composition (lean and fat mass).

To determine the sustainability of the effects of the supervised program, the study includes a 3-month follow-up time point (6 months post-baseline)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years or older
  • males or females
  • people diagnosed with any type of stage I-IIIa breast, prostate or colorectal cancer who have undergone and completed curative treatment (note: participants are eligible if they are currently receiving/scheduled to receive anti-hormonal therapy) at the Karolinska Comprehensive Cancer Centre, Sweden

Exclusion criteria

  • currently receiving or scheduled to receive cancer treatment (except anti-hormonal therapy)
  • any medical conditions that may prevent safe participation in the testing or exercise demands of the study
  • performing regular exercise throughout the last month defined as undertaking at least 150 mins moderate intensity aerobic exercise and two or more structured resistance exercise sessions per week
  • unable to read and speak Swedish.

Treatment and study plan

Exercise

Behavioral

A twice weekly, 3-month supervised exercise program of whole body resistance training using body weight and a resistance band, and moderate to high intensity aerobic activities, consisting of a consecutive series of timed exercises performed one after the other (14-18 on the Borg scale). Classes are conducted live in groups through Microsoft Teams. Participants will not receive any contact or exercise support in the 3-month follow-up period following the initial 3-month intervention

Primary outcomes

  1. Health-related quality of life

    Time frame: Baseline, 3 months

    Assessed by the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) (global quality of life summary scale). Patients responds to questions about their quality of life on a scale of 1- (not at all) to 4 (alot).

  2. Health-related quality of life

    Time frame: 3 months

    Assessed by the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) (global quality of life summary scale). Patients responds to questions about their quality of life on a scale of 1- (not at all) to 4 (alot).

Secondary outcomes

  1. Cancer related fatigue

    Time frame: Baseline

    Assessed by the Piper Fatigue scale (PFS) (total cancer related fatigue scale). Participants respond to questions about their fatigue on a scale of 1 (being positive)-10 (being bad/negative)

  2. Cancer related fatigue

    Time frame: 3 months

    Assessed by the Piper Fatigue scale (PFS) (total cancer related fatigue scale). Participants respond to questions about their fatigue on a scale of 1 (being positive)-10 (being bad/negative)

  3. Cancer related fatigue

    Time frame: 6 months

    Assessed by the Piper Fatigue scale (PFS) (total cancer related fatigue scale). Participants respond to questions about their fatigue on a scale of 1 (being positive)-10 (being bad/negative)

  4. Symptoms and symptom burden (total symptoms scale)

    Time frame: Baseline

    Assessed by the memorial symptom assessment scale (MSAS) (total symptoms scale). Patients respond to how often the have had the symptoms (1-almost never- 4 almost always), how severe the symptoms have been (1- light - 4- very severe) and how distressing the symptoms were to them (0- not at all- to 4 very)

  5. Symptoms and symptom burden (total symptoms scale)

    Time frame: 3 months

    Assessed by the memorial symptom assessment scale (MSAS) (total symptoms scale). Patients respond to how often the have had the symptoms (1-almost never- 4 almost always), how severe the symptoms have been (1- light - 4- very severe) and how distressing the symptoms were to them (0- not at all- to 4 very)

  6. Symptoms and symptom burden (total symptoms scale)

    Time frame: 6 months

    Assessed by the memorial symptom assessment scale (MSAS) (total symptoms scale). Patients respond to how often the have had the symptoms (1-almost never- 4 almost always), how severe the symptoms have been (1- light - 4- very severe) and how distressing the symptoms were to them (0- not at all- to 4 very)

  7. Cardiorespiratory fitness

    Time frame: Baseline

    Estimated/predicted maximal oxygen uptake, VO2max assessed by the Ekblom-Bak submaximal cycle test

  8. Cardiorespiratory fitness

    Time frame: 3 months

    Estimated/predicted maximal oxygen uptake, VO2max assessed by the Ekblom-Bak submaximal cycle test

  9. Cardiorespiratory fitness

    Time frame: 6 months

    Estimated/predicted maximal oxygen uptake, VO2max assessed by the Ekblom-Bak submaximal cycle test

  10. Physical function of the lower body

    Time frame: Baseline

    Assessed by the 5 sit to stand test (seconds)

  11. Physical function of the lower body

    Time frame: 3 months

    Assessed by the 5 sit to stand test (seconds)

  12. Physical function of the lower body

    Time frame: 6 months

    Assessed by the 5 sit to stand test (seconds)

  13. Upper body muscle strength

    Time frame: Baseline

    Assessed by a hypothetical 12-RM chest press test

  14. Upper body muscle strength

    Time frame: 3 months

    Assessed by a hypothetical 12-RM chest press test

  15. Upper body muscle strength

    Time frame: 6 months

    Assessed by a hypothetical 12-RM chest press test

  16. Lower body muscle strength

    Time frame: Baseline

    Assessed by a hypothetical 12-RM leg press test

  17. Lower body muscle strength

    Time frame: 3 months

    Assessed by a hypothetical 12-RM leg press test

  18. Lower body muscle strength

    Time frame: 6 months

    Assessed by a hypothetical 12-RM leg press test

  19. Whole body muscle mass

    Time frame: Baseline

    Assessed by bio impendence device (InBody770) (kg)

  20. Whole body muscle mass

    Time frame: 3 months

    Assessed by bio impendence device (InBody770) (kg)

  21. Whole body fat mass

    Time frame: 6 months

    Assessed by bio impendence device (InBody770) (kg)

  22. Whole body fat percentage

    Time frame: Baseline

    Assessed by bio impendence device (InBody770) (%)

  23. Whole body fat percentage

    Time frame: 3 months

    Assessed by bio impendence device (InBody770) (%)

  24. Whole body fat percentage

    Time frame: 6 months

    Assessed by bio impendence device (InBody770) (%)

  25. Self reported physical activity

    Time frame: Baseline

    Assessed by the Godin Leisure time physical activity questionnaire (mins). Patients detail how many minutes per week they have performed vigorous, moderate and low intensity physical activity

  26. Self reported physical activity

    Time frame: 3 months

    Assessed by the Godin Leisure time physical activity questionnaire (mins). Patients detail how many minutes per week they have performed vigorous, moderate and low intensity physical activity

  27. Self reported physical activity

    Time frame: 6 months

    Assessed by the Godin Leisure time physical activity questionnaire (mins). Patients detail how many minutes per week they have performed vigorous, moderate and low intensity physical activity

  28. Self efficacy of exercise

    Time frame: Baseline

    Assessed by the Self-Efficacy of Exercise (SEE) questionnaire (total score). Patients respond to questions ranging from 0 (not at all sure) to 10 (completely sure)

  29. Self efficacy of exercise

    Time frame: 3 months

    Assessed by the Self-Efficacy of Exercise (SEE) questionnaire (total score). Patients respond to questions ranging from 0 (not at all sure) to 10 (completely sure)

  30. Self efficacy of exercise

    Time frame: 6 months

    Assessed by the Self-Efficacy of Exercise (SEE) questionnaire (total score). Patients respond to questions ranging from 0 (not at all sure) to 10 (completely sure)

  31. Quality adjusted life years

    Time frame: Baseline

    Assessed by the EQ-5D-5L questionnaire . Patients rate their health from 0 (worst health you can imagine)-100 (best health you can imagine)

  32. Quality adjusted life years

    Time frame: 3 months

    Assessed by the EQ-5D-5L questionnaire . Patients rate their health from 0 (worst health you can imagine)-100 (best health you can imagine)

  33. Quality adjusted life years

    Time frame: 6 months

    Assessed by the EQ-5D-5L questionnaire . Patients rate their health from 0 (worst health you can imagine)-100 (best health you can imagine)

  34. Health-related quality of life

    Time frame: 6 months

    Assessed by the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) (global quality of life summary scale). Patients responds to questions about their quality of life on a scale of 1- (not at all) to 4 (alot).

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • SATS
  • Swedish Cancer Society

Registry information

Official study title

EX-MED Cancer Sweden: A Randomised Controlled Trial of Distance-based Exercise for People Treated for Cancer

Acronym: EX-MED

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 1, 2021
Registry last updated
Nov 18, 2024

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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