Exercise as Medicine for People With Cancer Sweden

NCT ID: NCT05064670

Last Updated: 2024-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-11

Study Completion Date

2024-10-21

Brief Summary

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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

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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

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Prostate Cancer Breast Cancer Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Exercise

Intervention Type 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

Control

The control group will receive routine clinical care according to (inter-) national guidelines

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swedish Cancer Society

OTHER

Sponsor Role collaborator

SATS

UNKNOWN

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Yvonne Wengstrom

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yvonne Wengström, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Karolinska Institute/ Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 40467967 (View on PubMed)

Kotte 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.

Reference Type DERIVED
PMID: 36800978 (View on PubMed)

Other Identifiers

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Dnr 2019-04151

Identifier Type: -

Identifier Source: org_study_id

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