Exercise as Medicine Cancer Sweden
Study Details
Study Description
Brief Summary
Exercise has shown to have beneficial health effects for patients with breast, prostate and colorectal cancer. Exercise programs have been successful at improving quality of life and other important health indicators in controlled, lab-based exercise interventions. To implement this knowledge into community programs, exercise programs must be trialed in community settings.
The aim of this study is to examine the effectiveness of an online community-based group exercise program within a larger model of care, for patients with breast, prostate and colorectal cancer. Participants will be randomized to a 3 month online 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 subgroup of the patients, personal trainers and Healthcare Professionals involved in the program will also be asked to participate in in depth interviews about the experiences of being involved in the program.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Exercise 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 online in group exercise classes twice weekly for 3 months |
Behavioral: Exercise
A 3 month supervised exercise program of resistance training (3 sets of 10-12 repetitions) using body weight and a resistance band, and moderate to high intensity aerobic activities (14-18 on the Borg scale) using callisthenic type activities. Classes are conducted live in groups through zoom. Participants will not receive any contact or exercise support in the 3 month followup period following the initial 3 month intervention
|
| No Intervention: Control The control group will receive routine clinical care according to (inter-) national guidelines |
Outcome Measures
Primary Outcome Measures
- Health related- quality of life [Change from baseline to 3 and 6 months post baseline]
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 Outcome Measures
- Cancer related fatigue [Change from baseline to 3 and 6 months post 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)
- Symptoms and symptom burden (total symptoms scale) [Change from baseline to 3 and 6 months post 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)
- Exercise capacity [Change from baseline to 3 and 6 months post baseline]
Peak power output assessed by modified Vo2 peak testing protocol
- Physical function of the lower body [Change from baseline to 3 and 6 months post baseline]
Assessed by the 5 sit to stand test (seconds)
- Upper body muscle strength [Change from baseline to 3 and 6 months post baseline]
Assessed by a hypothetical 12-RM chest press test
- Lower body muscle strength [Change from baseline to 3 and 6 months post baseline]
Assessed by a hypothetical 12-RM leg press test
- Whole body muscle mass [Change from baseline to 3 and 6 months post baseline]
Assessed by bio impendence device (InBody770) (kg)
- Whole body fat mass [Change from baseline to 3 and 6 months post baseline]
Assessed by bio impendence device (InBody770) (kg)
- Whole body fat percentage [Change from baseline to 3 and 6 months post baseline]
Assessed by bio impendence device (InBody770) (%)
- Self reported physical activity [Change from baseline to 3 and 6 months post 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
- Self efficacy of exercise [Change from baseline to 3 and 6 months post 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)
- Quality adjusted life years [Change from baseline to 3 and 6 months post 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)
Eligibility Criteria
Criteria
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 adjuvant treatment (note: participants are eligible if they are currently receiving/scheduled to receive anti-hormonal therapy) at the Karolinska University Hospital, Sweden
Exclusion Criteria:
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currently receiving or scheduled to receive cancer treatment (except anti-hormonal therapy)
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any medical conditions that may prevent safe participation in the testing or exercise demands of the study
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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
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unable to read and speak Swedish.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Karolinska Institute/ Karolinska University Hospital | Stockholm | Sweden |
Sponsors and Collaborators
- Karolinska Institutet
- Swedish Cancer Society
- SATS
Investigators
- Principal Investigator: Kate A Bolam, PhD, Karolinska Institutet
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Dnr 2019-04151