Prostate CancerEX-MEDNCT05064670
Exercise as Medicine for People With Cancer Sweden
A study testing Exercise in people with Prostate Cancer and Breast Cancer, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Breast Cancer, Colorectal Cancer
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 11 Jan 2022to 21 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EX-MED Cancer Sweden: A Randomised Controlled Trial of Distance-based Exercise for People Treated for Cancer
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.
Read the detailed description
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)
- Conditions
- Prostate Cancer, Breast Cancer, Colorectal Cancer
- Being tested
- Exercise
- Keywords
- Exercise, Cancer, Fitness, Distance-based, Home-based
- Medical subject headings
- Prostatic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Motor Activity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | The intervention group will, in addition to routine clinical care according to (inter-) national guidelines, receive an exercise program of resistance and aerobic exercise delivered live online by an upskilled exercise professional in group exercise classes twice weekly for 3 months Receives: Behavioral: Exercise |
| Control | No intervention | The control group will receive routine clinical care according to (inter-) national guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life
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).
Measured: Baseline, 3 months
Health-related quality of life
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).
Measured: 3 months
Secondary outcomes (34)
Cancer related fatigue
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)
Measured: Baseline
Cancer related fatigue
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)
Measured: 3 months
Cancer related fatigue
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)
Measured: 6 months
Symptoms and symptom burden (total symptoms scale)
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)
Measured: Baseline
Symptoms and symptom burden (total symptoms scale)
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)
Measured: 3 months
Symptoms and symptom burden (total symptoms scale)
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)
Measured: 6 months
Cardiorespiratory fitness
Estimated/predicted maximal oxygen uptake, VO2max assessed by the Ekblom-Bak submaximal cycle test
Measured: Baseline
Cardiorespiratory fitness
Estimated/predicted maximal oxygen uptake, VO2max assessed by the Ekblom-Bak submaximal cycle test
Measured: 3 months
Cardiorespiratory fitness
Estimated/predicted maximal oxygen uptake, VO2max assessed by the Ekblom-Bak submaximal cycle test
Measured: 6 months
Physical function of the lower body
Assessed by the 5 sit to stand test (seconds)
Measured: Baseline
Physical function of the lower body
Assessed by the 5 sit to stand test (seconds)
Measured: 3 months
Physical function of the lower body
Assessed by the 5 sit to stand test (seconds)
Measured: 6 months
Upper body muscle strength
Assessed by a hypothetical 12-RM chest press test
Measured: Baseline
Upper body muscle strength
Assessed by a hypothetical 12-RM chest press test
Measured: 3 months
Upper body muscle strength
Assessed by a hypothetical 12-RM chest press test
Measured: 6 months
Lower body muscle strength
Assessed by a hypothetical 12-RM leg press test
Measured: Baseline
Lower body muscle strength
Assessed by a hypothetical 12-RM leg press test
Measured: 3 months
Lower body muscle strength
Assessed by a hypothetical 12-RM leg press test
Measured: 6 months
Whole body muscle mass
Assessed by bio impendence device (InBody770) (kg)
Measured: Baseline
Whole body muscle mass
Assessed by bio impendence device (InBody770) (kg)
Measured: 3 months
Whole body fat mass
Assessed by bio impendence device (InBody770) (kg)
Measured: 6 months
Whole body fat percentage
Assessed by bio impendence device (InBody770) (%)
Measured: Baseline
Whole body fat percentage
Assessed by bio impendence device (InBody770) (%)
Measured: 3 months
Whole body fat percentage
Assessed by bio impendence device (InBody770) (%)
Measured: 6 months
Self reported physical activity
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
Measured: Baseline
Self reported physical activity
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
Measured: 3 months
Self reported physical activity
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
Measured: 6 months
Self efficacy of exercise
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)
Measured: Baseline
Self efficacy of exercise
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)
Measured: 3 months
Self efficacy of exercise
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)
Measured: 6 months
Quality adjusted life years
Assessed by the EQ-5D-5L questionnaire . Patients rate their health from 0 (worst health you can imagine)-100 (best health you can imagine)
Measured: Baseline
Quality adjusted life years
Assessed by the EQ-5D-5L questionnaire . Patients rate their health from 0 (worst health you can imagine)-100 (best health you can imagine)
Measured: 3 months
Quality adjusted life years
Assessed by the EQ-5D-5L questionnaire . Patients rate their health from 0 (worst health you can imagine)-100 (best health you can imagine)
Measured: 6 months
Health-related quality of life
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start11 Jan 2022
- Primary completion21 Oct 2024
- Study completion21 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Cancer Society, SATS - Sport Aerobic Trenings Senter
- Responsible party
- Principal investigator, Yvonne Wengstrom, Karolinska Institutet
- Investigators
- Yvonne Wengström, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064670
- Sponsor's protocol ID
- Dnr 2019-04151
- Acronym
- EX-MED
- Status last verified
- Nov 2024
- First submitted
- 22 Sep 2021
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The dataset will be stored via the Swedish National Data Service (SND) and provided a Digital Object Identifier (DOI).SND is a trusted digital repository, certified against CoreTrustSeal. Through their system DORIS, an examination of the metadata quality carried out by the KI Data Access Unit will be conducted of the data. When the data description is complete, it is published in the SND research data catalog.
Publications
Kotte M, Bolam KA, Altena R, Cormie P, Wengstrom Y, Mijwel S. Effects of live-remote exercise on quality of life and other health-related outcomes in cancer survivors: a randomised controlled trial. J Cancer Surviv. 2025 Jun 5. doi: 10.1007/s11764-025-01845-x. Online ahead of print.
PubMed 40467967Kotte M, Bolam KA, Mijwel S, Altena R, Cormie P, Wengstrom Y. Distance-based delivery of exercise for people treated for breast, prostate or colorectal cancer: a study protocol for a randomised controlled trial of EX-MED Cancer Sweden. Trials. 2023 Feb 17;24(1):116. doi: 10.1186/s13063-023-07152-z.
PubMed 36800978
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EX-MED Cancer Sweden: A Randomised Controlled Trial of Distance-based Exercise for People Treated for Cancer
- ClinicalTrials.gov ID
- NCT05064670
- Acronym / sponsor ID
- EX-MED / Dnr 2019-04151
- Conditions
- Prostate Cancer, Breast Cancer, Colorectal Cancer
- Keywords
- Exercise, Cancer, Fitness, Distance-based, Home-based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Swedish Cancer Society, SATS - Sport Aerobic Trenings Senter
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 21 Oct 2024 (actual)
- Study completion
- 21 Oct 2024 (actual)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseThe intervention group will, in addition to routine clinical care according to (inter-) national guidelines, receive an exercise program of resistance and aerobic exercise delivered live online by an upskilled exercise professional in group exercise classes twice weekly for 3 months |
| Control | No intervention | –The control group will receive routine clinical care according to (inter-) national guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseA 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 | Behavioural | Exercise |
Primary outcome
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).
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).
34 secondary outcomes
Cancer related fatigue
Time frame: Baseline
Cancer related fatigue
Time frame: 3 months
Cancer related fatigue
Time frame: 6 months
Symptoms and symptom burden (total symptoms scale)
Time frame: Baseline
Symptoms and symptom burden (total symptoms scale)
Time frame: 3 months
Symptoms and symptom burden (total symptoms scale)
Time frame: 6 months
Cardiorespiratory fitness
Time frame: Baseline
Cardiorespiratory fitness
Time frame: 3 months
Cardiorespiratory fitness
Time frame: 6 months
Physical function of the lower body
Time frame: Baseline
Physical function of the lower body
Time frame: 3 months
Physical function of the lower body
Time frame: 6 months
Upper body muscle strength
Time frame: Baseline
Upper body muscle strength
Time frame: 3 months
Upper body muscle strength
Time frame: 6 months
Lower body muscle strength
Time frame: Baseline
Lower body muscle strength
Time frame: 3 months
Lower body muscle strength
Time frame: 6 months
Whole body muscle mass
Time frame: Baseline
Whole body muscle mass
Time frame: 3 months
Whole body fat mass
Time frame: 6 months
Whole body fat percentage
Time frame: Baseline
Whole body fat percentage
Time frame: 3 months
Whole body fat percentage
Time frame: 6 months
Self reported physical activity
Time frame: Baseline
Self reported physical activity
Time frame: 3 months
Self reported physical activity
Time frame: 6 months
Self efficacy of exercise
Time frame: Baseline
Self efficacy of exercise
Time frame: 3 months
Self efficacy of exercise
Time frame: 6 months
Quality adjusted life years
Time frame: Baseline
Quality adjusted life years
Time frame: 3 months
Quality adjusted life years
Time frame: 6 months
Health-related quality of life
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Derived from this study: PubMed 40467967Kotte M, Bolam KA, Altena R, Cormie P, Wengstrom Y, Mijwel S. Effects of live-remote exercise on quality of life and other health-related outcomes in cancer survivors: a randomised controlled trial. J Cancer Surviv. 2025 Jun 5. doi: 10.1007/s11764-025-01845-x. Online ahead of print.
- Derived from this study: PubMed 36800978Kotte M, Bolam KA, Mijwel S, Altena R, Cormie P, Wengstrom Y. Distance-based delivery of exercise for people treated for breast, prostate or colorectal cancer: a study protocol for a randomised controlled trial of EX-MED Cancer Sweden. Trials. 2023 Feb 17;24(1):116. doi: 10.1186/s13063-023-07152-z.
- Individual participant dataSharing planned: Yes. The dataset will be stored via the Swedish National Data Service (SND) and provided a Digital Object Identifier (DOI).SND is a trusted digital repository, certified against CoreTrustSeal. Through their system DORIS, an examination of the metadata quality carried out by the KI Data Access Unit will be conducted of the data. When the data description is complete, it is published in the SND research data catalog.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne Wengström, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Prostate Cancer and Breast Cancer, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (time frame: Baseline, 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05064670, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.