An interventional study of Exercise in Prostate Cancer, Breast Cancer and Colorectal Cancer, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Supportive care
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.
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)
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's enrollment of 200 is above the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Karolinska Institutet is the lead sponsor of 1,145 studies on the registry; 274 are open to participants now.
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Exclusion Criteria:
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
Behavioral: Exercise
The control group will receive routine clinical care according to (inter-) national guidelines
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
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).
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 6 months
Cardiorespiratory fitness
Estimated/predicted maximal oxygen uptake, VO2max assessed by the Ekblom-Bak submaximal cycle test
Time frame: Baseline
Cardiorespiratory fitness
Estimated/predicted maximal oxygen uptake, VO2max assessed by the Ekblom-Bak submaximal cycle test
Time frame: 3 months
Cardiorespiratory fitness
Estimated/predicted maximal oxygen uptake, VO2max assessed by the Ekblom-Bak submaximal cycle test
Time frame: 6 months
Physical function of the lower body
Assessed by the 5 sit to stand test (seconds)
Time frame: Baseline
Physical function of the lower body
Assessed by the 5 sit to stand test (seconds)
Time frame: 3 months
Physical function of the lower body
Assessed by the 5 sit to stand test (seconds)
Time frame: 6 months
Upper body muscle strength
Assessed by a hypothetical 12-RM chest press test
Time frame: Baseline
Upper body muscle strength
Assessed by a hypothetical 12-RM chest press test
Time frame: 3 months
Upper body muscle strength
Assessed by a hypothetical 12-RM chest press test
Time frame: 6 months
Lower body muscle strength
Assessed by a hypothetical 12-RM leg press test
Time frame: Baseline
Lower body muscle strength
Assessed by a hypothetical 12-RM leg press test
Time frame: 3 months
Lower body muscle strength
Assessed by a hypothetical 12-RM leg press test
Time frame: 6 months
Whole body muscle mass
Assessed by bio impendence device (InBody770) (kg)
Time frame: Baseline
Whole body muscle mass
Assessed by bio impendence device (InBody770) (kg)
Time frame: 3 months
Whole body fat mass
Assessed by bio impendence device (InBody770) (kg)
Time frame: 6 months
Whole body fat percentage
Assessed by bio impendence device (InBody770) (%)
Time frame: Baseline
Whole body fat percentage
Assessed by bio impendence device (InBody770) (%)
Time frame: 3 months
Whole body fat percentage
Assessed by bio impendence device (InBody770) (%)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 6 months
Plan to share: 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.
Supporting information: Analytic code
Time frame: The data will become available within 5 years of study completion and will be available for visibility and accessibility for 10 years.
Access criteria: Researchers will have to apply through SND using DORIS to access the data. Once approved, the data is released.
Ran from Jan 2022 to primary completion in Oct 2024, 33 months.
Of 1,018 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 87. This study's 33 months is below that.
Counting every sponsor, half of 1,063 studies reached it within 45 months; a quarter within 22 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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