Exercise as Medicine for People With Cancer Sweden

Not Applicable

Completed

• Conditions: Prostate Cancer; Breast Cancer; Colorectal Cancer
• Interventions: Behavioral: Exercise

• Registration Number: NCT05064670
• Lead Sponsor: Karolinska Institutet

Brief 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. 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)

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-09-22
• Study First Submitted QC: 2021-09-22
• Study First Posted: 2021-10-01
• Study Start: 2022-01-11
• Primary Completion: 2024-10-21
• Study Completion: 2024-10-21
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	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 live online by an upskilled exercise professional in group exercise classes twice weekly for 3 months

Primary Outcome Measures

Name	Time	Method
Health-related quality of life	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 Outcome Measures

Name	Time	Method
Upper body muscle strength	6 months	Assessed by a hypothetical 12-RM chest press test
Symptoms and symptom burden (total symptoms scale)	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)
Self reported physical activity	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
Cardiorespiratory fitness	6 months	Estimated/predicted maximal oxygen uptake, VO2max assessed by the Ekblom-Bak submaximal cycle test
Lower body muscle strength	6 months	Assessed by a hypothetical 12-RM leg press test
Whole body muscle mass	3 months	Assessed by bio impendence device (InBody770) (kg)
Whole body fat mass	6 months	Assessed by bio impendence device (InBody770) (kg)
Self efficacy of exercise	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)
Cancer related fatigue	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)
Physical function of the lower body	6 months	Assessed by the 5 sit to stand test (seconds)
Health-related quality of life	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).
Whole body fat percentage	6 months	Assessed by bio impendence device (InBody770) (%)
Quality adjusted life years	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)

Trial Locations

Locations (1)

Karolinska Institute/ Karolinska University Hospital; 🇸🇪 Stockholm, Sweden