CancerREACTNCT07159815
REACT - Resistance Exercise After Cancer Treatment
A study testing Digital follow-up, On-site follow-up and Resistance exercise in people with Cancer, run by Inland Norway University of Applied Sciences at 4 sites in Norway.
Trial summary
Resistance exercise has been shown to improve several important health variables after cancer and cancer related treatment, but unfortunately the adherence to resistance exercise is low. Typical reported exercise barriers are inconvenient location (e.g. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Digital follow-up, On-site follow-up and Resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 4 sitesNorway
- Study dates
- 1 Aug 2023to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 18 years and able to give informed consent
- Previously diagnosed with any form of cancer and having completed systemic chemotherapy, immunotherapy or targeted therapies or local radiotherapy not more than 5 years earlier
- Living within 20 km of one of the exercise locations (Lillehammer, Gjøvik, or Hamar)
- Life expectancy of more than 12 months
- Access to digital equipment at home (e.g. PC and/or tablet) and an email address, enabling participation on the digital exercise platform
- Able to understand the Norwegian language
Who cannot join
- Co-morbidities prohibiting exercise according to the protocol, such as serious cardiac, pulmonary, or other organ diseases
- Conditions caused by the cancer that prohibits exercise, such as recent major surgery, fractures, or pain
- Still undergoing active cancer treatment
- Life expectancy of less than 12 months
- Reduced mental capacity such that the participant is unable to give informed consent and follow the program
- Has performed regular strength training (two or more times per week) within the last three months
- Note on reference groups:
- In addition to the randomized controlled trial, the study includes two non-randomized reference groups that are allocated to the digital home-based intervention only and undergo the same test protocol as the randomized participants. These are: (i) patients undergoing active cancer treatment, and (ii) patients who have completed treatment but live more than 20 km from an exercise location. Reference-group participants must otherwise meet the same inclusion criteria regarding age, cancer diagnosis, life expectancy, digital access, and language, and are subject to the same exclusion criteria, except that ongoing active treatment and distance from an exercise location are permitted as defining features of the respective groups. Patients undergoing active cancer treatment that is expected to confer a high risk of bone marrow suppression - leading to infections, bleeding, and/or severely reduced physical capacity - are excluded.
Trial locations and contacts
4 sites in 1 country.
Norway4 sites
Innlandet Hospital Trust/ Pusterommet Gjøvik
Gjøvik
The Hamar Training Centre
Hamar
Aktivklinikken
Lillehammer
Inland Norway University of Applied Sciences
Lillehammer
About this study
Official title: Comparing the Health Benefits of Digital Home-based Resistance Exercise and Supervised On-site Resistance Exercise in Cancer Patients After Treatment - a 12 Week RCT.
Resistance exercise has been shown to improve several important health variables after cancer and cancer related treatment, but unfortunately the adherence to resistance exercise is low. Typical reported exercise barriers are inconvenient location (e.g. long distance from home), exercise at an unfavorable time of the day, inadequate access to cancer-specific exercise and insufficient recommendations from healthcare providers. Thus, there is need for more research on resistance exercise with an alternative approach in cancer rehabilitation, that potentially can target a broad range of patients, despite their domicile. In Norway, the foundation "Active against cancer" has established exercise locations targeting cancer patients in several hospitals, and today they also offer digital home-based exercise sessions. Therefore, the overall research objectives are to compare the efficacy of a 12 weeks digital, home-based resistance exercise program for cancer patients after treatment on functional, mental, and metabolic health, compared to the same program conducted in a studio under guidance of an instructor. The primary aim is to compare the effect on exercise adherence between digital home-based exercise program and the on-site guided program in cancer patients after treatment. Secondary aims are to compare the two groups on several functional health outcomes, mental health outcomes and metabolic health markers. In addition to the randomized controlled trial, the project includes two non-randomized cohorts - patients undergoing active cancer treatment, and patients living more than 20 km from an exercise location - who follow the digital home-based program and the same test protocol.
Read the detailed description
The project is an assessor-blinded randomized controlled trial investigating whether a 12-week digital, home-based resistance exercise program is equivalent to the same program delivered on-site under instructor guidance, for cancer patients after treatment. The primary outcome is exercise adherence; secondary outcomes cover functional, mental, and metabolic health.
Eligible participants living within 20 km of an exercise location (Lillehammer, Gjøvik, or Hamar) are stratified by sex and randomized 1:1 (block size 10) to digital home-based or on-site resistance exercise. Both arms perform the identical program: two 40-minute full-body sessions per week for 12 weeks (24 sessions total).
In addition to the RCT, the project includes two non-randomized reference groups that undergo the same test protocol and the digital home-based intervention only: (i) patients undergoing active cancer treatment, and (ii) eligible patients after treatment living more than 20 km from an on-site location. These reference groups support additional analyses of adherence and health benefits in patients who are undergoing active treatment or for whom on-site attendance is impractical.
The trial is designed and powered as an equivalence study: the central hypothesis is that home-based delivery achieves adherence, and functional, mental, and metabolic health benefits, equivalent to on-site delivery. Outcomes are assessed at baseline and within two weeks after the intervention, and again at approximately 12 months after inclusion to capture long-term effects. Recruitment and intervention are delivered across multiple periods (a 2023 pilot, followed by main periods in 2024 and 2025, with a further period in 2026) to accumulate sufficient participants.
The randomized controlled trial targets 120 participants, with 60 allocated to each arm (digital vs on-site). The two non-randomized reference groups are enrolled in addition to the trial; their size is not fixed in advance, as enrollment depends on the number of eligible patients identified during the recruitment periods.
- Conditions
- Cancer
- Being tested
- Digital follow-up, On-site follow-up, Resistance exercise
- Keywords
- cancer rehabilitation, cancer survivors, resistance training, exercise adherence, home-based exercise, telerehabilitation, digital health, exercise oncology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital follow-upOther
Also called Cancer rehabilitation, digital follow-up
See the arm/group description.
On-site follow-upOther
Also called On-site cancer rehabilitation, on-site follow-up
See the arm/group description.
Resistance exerciseBehavioural
Also called Cancer rehabilitation
See the arm/group description.
| Study group | Role | What they receive |
|---|---|---|
| Digital home-based resistance exercise | Experimental | Participants in the digital group will need an e-mail and access to a pc and/or ipad at home. They will get access to a closed group on a digital platform, for participants in the project only. They will be asked to perform two pre-recorded resistance exercise sessions each week, for 12 weeks. Each session last for 40 minutes, and include 10 minutes of warm-up (dynamic mobility and low impact), 25 minutes of resistance exercises (8-15 repetitions x 2-4 sets), and 5 minutes of cool-down and stretching. A total of 24 exercises will be performed over the period of 12 weeks. Receives: Other: Digital follow-up; Behavioral: Resistance exercise |
| On-site resistance exercise | Experimental | Participants in the on-site group will be asked to participate in resistance exercise on-site with instructor, two times a week for 12 weeks. They will follow the exact same exercise program as the digital group. Participants living around the Gjøvik area will have their exercise sessions at The Inland hospital Gjøvik (with physiotherapist and instructor supervising/mentoring the students), and for participants living around Lillehammer the exercise will be held at a medical clinic (with physiotherapist and instructor supervising/mentoring the students). Participants living around the Hamar area will have their exercise sessions at a fitness center (with physiotherapist and instructor supervising/mentoring the students). A total of 24 exercises will be performed over the period of 12 weeks. Receives: Other: On-site follow-up; Behavioral: Resistance exercise |
| Reference group - Active treatment | Other | Patients undergoing active cancer treatment, allocated to the digital home-based resistance exercise intervention only and not randomized. They follow the same 12-week program (two 40-minute sessions weekly, 24 sessions total) and the same test protocol as the randomized participants. Assigned intervention: Digital home-based resistance exercise. Receives: Other: Digital follow-up; Behavioral: Resistance exercise |
| Reference group - Distance (>20 km) | Other | Patients who have completed cancer treatment and live more than 20 km from an on-site exercise location, allocated to the digital home-based resistance exercise intervention only and not randomized. They follow the same 12-week program and test protocol as the randomized participants. Assigned intervention: Digital home-based resistance exercise. Receives: Other: Digital follow-up; Behavioral: Resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise adherence
Percentage of completed prescribed exercise sessions.
Measured: Baseline to post-test (0-12 weeks)
Secondary outcomes (49)
Sustained exercise behaviour (12-month follow-up)
Self-reported resistance exercise behaviour at long-term follow-up, measured to assess maintenance of exercise after the supervised 12-week intervention period. Assessed using the physical activity registration questionnaire.
Measured: 12 months after inclusion (approximately)
Fatigue
Fatigue measured using "Chalder's Fatigue" questionnaire. This is 11 item questionnaire, where respondents first answer with a 1 or a 0 to indicate if the question apply to them or not, and then there is a Likert scale from 0 to 3 indicating each statement from "less than usual" to "much more than usual". The first part indicates the number of symptoms, and the other part the intensity of the symptoms. The global score can range from 0-33, where higher score indicates more fatigue.
Measured: Baseline to post-test (0-12 weeks)
Fatigue (12-month follow-up)
Fatigue measured using "Chalder's Fatigue" questionnaire. This is 11 item questionnaire, where respondents first answer with a 1 or a 0 to indicate if the question apply to them or not, and then there is a Likert scale from 0 to 3 indicating each statement from "less than usual" to "much more than usual". The first part indicates the number of symptoms, and the other part the intensity of the symptoms. The global score can range from 0-33, where higher score indicates more fatigue.
Measured: 12 months after inclusion (approximately)
Health-related Quality of Life: SF-36 questionnaire
Quality of life will be measured using the Short Form Health Survey (SF-36 questionnaire). SF-36 include 36 questions, covering eight domains of health. Each domain has a score being converted and pooled using a scoring key, indicating high or low quality of life. Likert scales and yes/no options are used in the questionnaire. The score in SF-36 are standardized in a two-step process by the SF-36v2 software, to obtain a scoring algoritm from 0-100. A higher score indicates better health state, and a score of 50 have been proposed as a normative value.
Measured: Baseline to post-test (0-12 weeks)
Health-related Quality of Life: SF-36 questionnaire (12-month follow-up)
Quality of life will be measured using the Short Form Health Survey (SF-36 questionnaire). SF-36 include 36 questions, covering eight domains of health. Each domain has a score being converted and pooled using a scoring key, indicating high or low quality of life. Likert scales and yes/no options are used in the questionnaire. The score in SF-36 are standardized in a two-step process by the SF-36v2 software, to obtain a scoring algoritm from 0-100. A higher score indicates better health state, and a score of 50 have been proposed as a normative value.
Measured: 12 months after inclusion (approximately)
Cancer-related quality of life
Cancer-related quality of life will be measured using the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC QLQ-C30 questionnaire), including five functional scales, three symptom scales, a global health status scale and six single items. All items range from 0 to 100, with a high scale score representing a higher response level, meaning a high score on the functional scale represents high level of functioning, a high score for the global health status represents high quality of life, but a high score on the symptom scale represents a high level of symptom.
Measured: Baseline to post-test (0-12 weeks)
Cancer-related quality of life (12-month follow-up)
Cancer-related quality of life will be measured using the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC QLQ-C30 questionnaire), including five functional scales, three symptom scales, a global health status scale and six single items. All items range from 0 to 100, with a high scale score representing a higher response level, meaning a high score on the functional scale represents high level of functioning, a high score for the global health status represents high quality of life, but a high score on the symptom scale represents a high level of symptom.
Measured: 12 months after inclusion (approximately)
Depression
Despression measured using the "Patient Health Questionnaire" (PHQ9). PHQ9 is a Likert scale where respondens score 0-4 on the nine items (ranging from "not at all" to "nearly every day". The total number of points are 27, and score 20-27 indicate severe depression. A total score from 1-4 indicate minimal depression, a score 5-9 indicate mild depression, score 10-14 indicate moderate depression and 15-19 indicate moderately severe depression.
Measured: Baseline to post-test (0-12 weeks)
Depression (12-month follow-up)
Despression measured using the "Patient Health Questionnaire" (PHQ9). PHQ9 is a Likert scale where respondens score 0-4 on the nine items (ranging from "not at all" to "nearly every day". The total number of points are 27, and score 20-27 indicate severe depression. A total score from 1-4 indicate minimal depression, a score 5-9 indicate mild depression, score 10-14 indicate moderate depression and 15-19 indicate moderately severe depression.
Measured: 12 months after inclusion (approximately)
Maximal muscle strength
Maximal muscle strength measured using one repetition maximum test (1RM) in leg press (Keiser)
Measured: Baseline to post-test (0-12 weeks)
Maximal muscle strength (12-month follow-up)
Maximal muscle strength measured using one repetition maximum test (1RM) in leg press (Keiser)
Measured: 12 months after inclusion (approximately)
Muscular endurance (legs)
Muscular endurance measured using correctly performed number of repetitions at 70% of 1RM in leg press (Keiser)
Measured: Baseline to post-test (0-12 weeks)
Muscular endurance (legs) (12-month follow-up)
Muscular endurance measured using correctly performed number of repetitions at 70% of 1RM in leg press (Keiser)
Measured: 12 months after inclusion (approximately)
Muscular endurance (upper body)
Muscular endurance measured as correctly performed number of repetitions (push-ups)
Measured: Baseline to post-test (0-12 weeks)
Muscular endurance (upper body) (12-month follow-up)
Muscular endurance measured as correctly performed number of repetitions (push-ups)
Measured: 12 months after inclusion (approximately)
Functional fitness, six minutes step test
Functional fitness measured using the "six minutes step" test
Measured: Baseline to post-test (0-12 weeks)
Functional fitness, six minutes step test (12-month follow-up)
Functional fitness measured using the "six minutes step" test
Measured: 12 months after inclusion (approximately)
Muscle mass, DXA scan
Muscle mass measured using the whole-body DXA scan
Measured: Baseline to post-test (0-12 weeks)
Muscle mass, DXA scan (12-month follow-up)
Muscle mass measured using the whole-body DXA scan
Measured: 12 months after inclusion (approximately)
Visceral fat mass, DXA scan
Visceral fat mass measured using the whole-body DXA scan
Measured: Baseline to post-test (0-12 weeks)
Visceral fat mass, DXA scan (12-month follow-up)
Visceral fat mass measured using the whole-body DXA scan
Measured: 12 months after inclusion (approximately)
Fat mass, DXA scan
Fat mass measured using the whole-body DXA scan
Measured: Baseline to post-test (0-12 weeks)
Fat mass, DXA scan (12-month follow-up)
Fat mass measured using the whole-body DXA scan
Measured: 12 months after inclusion (approximately)
Bone mineral density, DXA scan
Bone mineral density measured using the whole-body DXA scan
Measured: Baseline to post-test (0-12 weeks)
Bone mineral density, DXA scan (12-month follow-up)
Bone mineral density measured using the whole-body DXA scan
Measured: 12 months after inclusion (approximately)
Muscle mass, ultrasound
Muscle mass measured using ultrasound to detect muscle thivkness of m.vastus lateralis
Measured: Baseline to post-test (0-12 weeks)
Muscle mass, ultrasound (12-month follow-up)
Muscle mass measured using ultrasound to detect muscle thivkness of m.vastus lateralis
Measured: 12 months after inclusion (approximately)
Lipoprotein profile (subclasses of LDL, HDL)
Lipoprotein profile (subclasses of LDL, HDL) measured taking venous blood samples
Measured: Baseline to post-test (0-12 weeks)
Lipoprotein profile (subclasses of LDL, HDL) (12-month follow-up)
Lipoprotein profile (subclasses of LDL, HDL) measured taking venous blood samples
Measured: 12 months after inclusion (approximately)
Blood pressure at rest
Both systolic and diastolic blood pressure at rest measured using automated upper-arm blood pressure cuff
Measured: Baseline to post-test (0-12 weeks)
Blood pressure at rest (12-month follow-up)
Both systolic and diastolic blood pressure at rest measured using automated upper-arm blood pressure cuff
Measured: 12 months after inclusion (approximately)
Fasting blood glucose
Fasting blood glucose measured in serum
Measured: Baseline to post-test (0-12 weeks)
Fasting blood glucose (12-month follow-up)
Fasting blood glucose measured in serum
Measured: 12 months after inclusion (approximately)
Glycated hemoglobin (HbA1c)
Long-term blood glucose control measured as glycated hemoglobin (HbA1c) in venous blood samples
Measured: Baseline to post-test (0-12 weeks)
Glycated hemoglobin (HbA1c) (12-month follow-up)
Long-term blood glucose control measured as glycated hemoglobin (HbA1c) in venous blood samples
Measured: 12 months after inclusion (approximately)
Waist circumference
Circumference of the waist measured using measuring tape
Measured: Baseline to post-test (0-12 weeks)
Waist circumference (12-month follow-up)
Circumference of the waist measured using measuring tape
Measured: 12 months after inclusion (approximately)
Glucose tolerance (c-peptide)
Oral glucose tolerance test (c-peptide) using venous blood samples
Measured: Baseline to post-test (0-12 weeks)
Glucose tolerance (c-peptide) (12-month follow-up)
Oral glucose tolerance test (c-peptide) using venous blood samples
Measured: 12 months after inclusion (approximately)
Glucose tolerance (glucose)
Oral glucose tolerance test (glucose) using venous blood samples
Measured: Baseline to post-test (0-12 weeks)
Glucose tolerance (glucose) (12-month follow-up)
Oral glucose tolerance test (glucose) using venous blood samples
Measured: 12 months after inclusion (approximately)
Triglycerides
Triglycerides measured in venous blood samples
Measured: Baseline to post-test (0-12 weeks)
Triglycerides (12-month follow-up)
Triglycerides measured in venous blood samples
Measured: 12 months after inclusion (approximately)
Berg Balance Scale (BBS)
Functional balance measured using the Berg Balance Scale (BBS). The scale consists of 14 tasks reflecting everyday balance demands, each scored by an assessor from 0 (unable to perform) to 4 (independent performance), giving a total score from 0 to 56. A higher score indicates better functional balance.
Measured: Baseline to post-test (0-12 weeks)
Berg Balance Scale (BBS) (12-month follow-up)
Functional balance measured using the Berg Balance Scale (BBS). The scale consists of 14 tasks reflecting everyday balance demands, each scored by an assessor from 0 (unable to perform) to 4 (independent performance), giving a total score from 0 to 56. A higher score indicates better functional balance.
Measured: 12 months after inclusion (approximately)
C-reactive protein (CRP)
Systemic inflammation measured as C-reactive protein (CRP) concentration in venous blood samples.
Measured: Baseline to post-test (12 weeks)
C-reactive protein (CRP) (12-month follow-up)
Systemic inflammation measured as C-reactive protein (CRP) concentration in venous blood samples.
Measured: 12 months after inclusion (approximately)
Metabolic syndrome (collective assessment)
Composite assessment of metabolic syndrome based on its established diagnostic components, including waist circumference, blood pressure, fasting blood glucose, triglycerides, and HDL cholesterol. Metabolic syndrome status is determined from the number of component criteria met.
Measured: Baseline to post-test (12 weeks)
Metabolic syndrome (collective assessment) (12-month follow-up)
Composite assessment of metabolic syndrome based on its established diagnostic components, including waist circumference, blood pressure, fasting blood glucose, triglycerides, and HDL cholesterol. Metabolic syndrome status is determined from the number of component criteria met.
Measured: 12 months after inclusion (approximately)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Aug 2023
- Primary completion15 Jun 2026 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The project is an assessor-blinded randomized controlled trial, where included participants will be randomized to either 12 weeks of digital home-based resistance exercise or the same program conducted in a studio under guidance of an instructor.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inland Norway University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Sykehuset Innlandet HF
- Responsible party
- Principal investigator, Stian Ellefsen, Inland Norway University of Applied Sciences
- Investigators
- Stian Ellefsen, Professor, Principal investigator, Inland Norway University of Applied SciencesArne Kolstad, Professor, Study director, Sykehuset Innlandet HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159815
- Sponsor's protocol ID
- TR033
- Acronym
- REACT
- Status last verified
- May 2026
- First submitted
- 15 Aug 2023
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Health Benefits of Digital Home-based Resistance Exercise and Supervised On-site Resistance Exercise in Cancer Patients After Treatment - a 12 Week RCT.
- ClinicalTrials.gov ID
- NCT07159815
- Acronym / sponsor ID
- REACT / TR033
- Conditions
- Cancer
- Keywords
- cancer rehabilitation, cancer survivors, resistance training, exercise adherence, home-based exercise, telerehabilitation, digital health, exercise oncology
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Inland Norway University of Applied SciencesUniversity, hospital or other
- Collaborators
- Sykehuset Innlandet HF
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 8 Sep 2025 (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.
Resistance exercise has been shown to improve several important health variables after cancer and cancer related treatment, but unfortunately the adherence to resistance exercise is low. Typical reported exercise barriers are inconvenient location (e.g. long distance from home), exercise at an unfavorable time of the day, inadequate access to cancer-specific exercise and insufficient recommendations from healthcare providers. Thus, there is need for more research on resistance exercise with an alternative approach in cancer rehabilitation, that potentially can target a broad range of patients, despite their domicile. In Norway, the foundation "Active against cancer" has established exercise locations targeting cancer patients in several hospitals, and today they also offer digital home-based exercise sessions. Therefore, the overall research objectives are to compare the efficacy of a 12 weeks digital, home-based resistance exercise program for cancer patients after treatment on functional, mental, and metabolic health, compared to the same program conducted in a studio under guidance of an instructor. The primary aim is to compare the effect on exercise adherence between digital home-based exercise program and the on-site guided program in cancer patients after treatment. Secondary aims are to compare the two groups on several functional health outcomes, mental health outcomes and metabolic health markers. In addition to the randomized controlled trial, the project includes two non-randomized cohorts - patients undergoing active cancer treatment, and patients living more than 20 km from an exercise location - who follow the digital home-based program and the same test protocol.
Detailed description
The project is an assessor-blinded randomized controlled trial investigating whether a 12-week digital, home-based resistance exercise program is equivalent to the same program delivered on-site under instructor guidance, for cancer patients after treatment. The primary outcome is exercise adherence; secondary outcomes cover functional, mental, and metabolic health.
Eligible participants living within 20 km of an exercise location (Lillehammer, Gjøvik, or Hamar) are stratified by sex and randomized 1:1 (block size 10) to digital home-based or on-site resistance exercise. Both arms perform the identical program: two 40-minute full-body sessions per week for 12 weeks (24 sessions total).
In addition to the RCT, the project includes two non-randomized reference groups that undergo the same test protocol and the digital home-based intervention only: (i) patients undergoing active cancer treatment, and (ii) eligible patients after treatment living more than 20 km from an on-site location. These reference groups support additional analyses of adherence and health benefits in patients who are undergoing active treatment or for whom on-site attendance is impractical.
The trial is designed and powered as an equivalence study: the central hypothesis is that home-based delivery achieves adherence, and functional, mental, and metabolic health benefits, equivalent to on-site delivery. Outcomes are assessed at baseline and within two weeks after the intervention, and again at approximately 12 months after inclusion to capture long-term effects. Recruitment and intervention are delivered across multiple periods (a 2023 pilot, followed by main periods in 2024 and 2025, with a further period in 2026) to accumulate sufficient participants.
The randomized controlled trial targets 120 participants, with 60 allocated to each arm (digital vs on-site). The two non-randomized reference groups are enrolled in addition to the trial; their size is not fixed in advance, as enrollment depends on the number of eligible patients identified during the recruitment periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- The project is an assessor-blinded randomized controlled trial, where included participants will be randomized to either 12 weeks of digital home-based resistance exercise or the same program conducted in a studio under guidance of an instructor.
| Arm | Type | Receives |
|---|---|---|
| Digital home-based resistance exercise | Experimental | Other: Digital follow-up, Behavioral: Resistance exerciseParticipants in the digital group will need an e-mail and access to a pc and/or ipad at home. They will get access to a closed group on a digital platform, for participants in the project only. They will be asked to perform two pre-recorded resistance exercise sessions each week, for 12 weeks. Each session last for 40 minutes, and include 10 minutes of warm-up (dynamic mobility and low impact), 25 minutes of resistance exercises (8-15 repetitions x 2-4 sets), and 5 minutes of cool-down and stretching. A total of 24 exercises will be performed over the period of 12 weeks. |
| On-site resistance exercise | Experimental | Other: On-site follow-up, Behavioral: Resistance exerciseParticipants in the on-site group will be asked to participate in resistance exercise on-site with instructor, two times a week for 12 weeks. They will follow the exact same exercise program as the digital group. Participants living around the Gjøvik area will have their exercise sessions at The Inland hospital Gjøvik (with physiotherapist and instructor supervising/mentoring the students), and for participants living around Lillehammer the exercise will be held at a medical clinic (with physiotherapist and instructor supervising/mentoring the students). Participants living around the Hamar area will have their exercise sessions at a fitness center (with physiotherapist and instructor supervising/mentoring the students). A total of 24 exercises will be performed over the period of 12 weeks. |
| Reference group - Active treatment | Other | Other: Digital follow-up, Behavioral: Resistance exercisePatients undergoing active cancer treatment, allocated to the digital home-based resistance exercise intervention only and not randomized. They follow the same 12-week program (two 40-minute sessions weekly, 24 sessions total) and the same test protocol as the randomized participants. Assigned intervention: Digital home-based resistance exercise. |
| Reference group - Distance (>20 km) | Other | Other: Digital follow-up, Behavioral: Resistance exercisePatients who have completed cancer treatment and live more than 20 km from an on-site exercise location, allocated to the digital home-based resistance exercise intervention only and not randomized. They follow the same 12-week program and test protocol as the randomized participants. Assigned intervention: Digital home-based resistance exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 18 years and able to give informed consent
- Previously diagnosed with any form of cancer and having completed systemic chemotherapy, immunotherapy or targeted therapies or local radiotherapy not more than 5 years earlier
- Living within 20 km of one of the exercise locations (Lillehammer, Gjøvik, or Hamar)
- Life expectancy of more than 12 months
- Access to digital equipment at home (e.g. PC and/or tablet) and an email address, enabling participation on the digital exercise platform
Key exclusion criteria (8 listed)
- Co-morbidities prohibiting exercise according to the protocol, such as serious cardiac, pulmonary, or other organ diseases
- Conditions caused by the cancer that prohibits exercise, such as recent major surgery, fractures, or pain
- Still undergoing active cancer treatment
- Life expectancy of less than 12 months
- Reduced mental capacity such that the participant is unable to give informed consent and follow the program
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 |
|---|---|---|
| Digital follow-upAlso: Cancer rehabilitation, digital follow-upSee the arm/group description. | Other | Digital home-based resistance exercise, Reference group - Active treatment, Reference group - Distance (>20 km) |
| On-site follow-upAlso: On-site cancer rehabilitation, on-site follow-upSee the arm/group description. | Other | On-site resistance exercise |
| Resistance exerciseAlso: Cancer rehabilitationSee the arm/group description. | Behavioural | Digital home-based resistance exercise, On-site resistance exercise, Reference group - Active treatment, Reference group - Distance (>20 km) |
Primary outcome
Exercise adherence
Time frame: Baseline to post-test (0-12 weeks)
Percentage of completed prescribed exercise sessions.
49 secondary outcomes
Sustained exercise behaviour (12-month follow-up)
Time frame: 12 months after inclusion (approximately)
Fatigue
Time frame: Baseline to post-test (0-12 weeks)
Fatigue (12-month follow-up)
Time frame: 12 months after inclusion (approximately)
Health-related Quality of Life: SF-36 questionnaire
Time frame: Baseline to post-test (0-12 weeks)
Health-related Quality of Life: SF-36 questionnaire (12-month follow-up)
Time frame: 12 months after inclusion (approximately)
Cancer-related quality of life
Time frame: Baseline to post-test (0-12 weeks)
Cancer-related quality of life (12-month follow-up)
Time frame: 12 months after inclusion (approximately)
Depression
Time frame: Baseline to post-test (0-12 weeks)
Depression (12-month follow-up)
Time frame: 12 months after inclusion (approximately)
Maximal muscle strength
Time frame: Baseline to post-test (0-12 weeks)
Maximal muscle strength (12-month follow-up)
Time frame: 12 months after inclusion (approximately)
Muscular endurance (legs)
Time frame: Baseline to post-test (0-12 weeks)
Muscular endurance (legs) (12-month follow-up)
Time frame: 12 months after inclusion (approximately)
Muscular endurance (upper body)
Time frame: Baseline to post-test (0-12 weeks)
Muscular endurance (upper body) (12-month follow-up)
Time frame: 12 months after inclusion (approximately)
Functional fitness, six minutes step test
Time frame: Baseline to post-test (0-12 weeks)
Functional fitness, six minutes step test (12-month follow-up)
Time frame: 12 months after inclusion (approximately)
Muscle mass, DXA scan
Time frame: Baseline to post-test (0-12 weeks)
Muscle mass, DXA scan (12-month follow-up)
Time frame: 12 months after inclusion (approximately)
Visceral fat mass, DXA scan
Time frame: Baseline to post-test (0-12 weeks)
Visceral fat mass, DXA scan (12-month follow-up)
Time frame: 12 months after inclusion (approximately)
Fat mass, DXA scan
Time frame: Baseline to post-test (0-12 weeks)
Fat mass, DXA scan (12-month follow-up)
Time frame: 12 months after inclusion (approximately)
Bone mineral density, DXA scan
Time frame: Baseline to post-test (0-12 weeks)
Bone mineral density, DXA scan (12-month follow-up)
Time frame: 12 months after inclusion (approximately)
Muscle mass, ultrasound
Time frame: Baseline to post-test (0-12 weeks)
Muscle mass, ultrasound (12-month follow-up)
Time frame: 12 months after inclusion (approximately)
Lipoprotein profile (subclasses of LDL, HDL)
Time frame: Baseline to post-test (0-12 weeks)
Lipoprotein profile (subclasses of LDL, HDL) (12-month follow-up)
Time frame: 12 months after inclusion (approximately)
Blood pressure at rest
Time frame: Baseline to post-test (0-12 weeks)
Blood pressure at rest (12-month follow-up)
Time frame: 12 months after inclusion (approximately)
Fasting blood glucose
Time frame: Baseline to post-test (0-12 weeks)
Fasting blood glucose (12-month follow-up)
Time frame: 12 months after inclusion (approximately)
Glycated hemoglobin (HbA1c)
Time frame: Baseline to post-test (0-12 weeks)
Glycated hemoglobin (HbA1c) (12-month follow-up)
Time frame: 12 months after inclusion (approximately)
Waist circumference
Time frame: Baseline to post-test (0-12 weeks)
Waist circumference (12-month follow-up)
Time frame: 12 months after inclusion (approximately)
Glucose tolerance (c-peptide)
Time frame: Baseline to post-test (0-12 weeks)
Glucose tolerance (c-peptide) (12-month follow-up)
Time frame: 12 months after inclusion (approximately)
Glucose tolerance (glucose)
Time frame: Baseline to post-test (0-12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Stian Ellefsen, Professor principal investigator
Inland Norway University of Applied Sciences
Arne Kolstad, Professor study director
Sykehuset Innlandet HF
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital follow-up, On-site follow-up and Resistance exercise in people with Cancer, run by Inland Norway University of Applied Sciences at 4 sites in Norway.
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 6 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway. 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?
This study is still under way. Results are not available in the source record yet.
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?
Exercise adherence (time frame: Baseline to post-test (0-12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2026.