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| Name | Class |
|---|---|
| Sykehuset Innlandet HF | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital follow-up | Other | See the arm/group description. |
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| Measure | Description | Time Frame |
|---|---|---|
| Exercise adherence | Percentage of completed prescribed exercise sessions. | Baseline to post-test (0-12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months after inclusion (approximately) |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Stian Ellefsen, Professor | Inland Norway University of Applied Sciences | Principal Investigator |
| Arne Kolstad, Professor | Sykehuset Innlandet HF | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innlandet Hospital Trust/ Pusterommet Gjøvik | Gjøvik | Norway | ||||
| The Hamar Training Centre |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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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.
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Assessment of all the outcomes will be performed in a blinded fashion by assessors/investigators.
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| 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. |
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| On-site follow-up | Other | See the arm/group description. |
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| Resistance exercise | Behavioral | See the arm/group description. |
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| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 12 months after inclusion (approximately) |
| Maximal muscle strength | Maximal muscle strength measured using one repetition maximum test (1RM) in leg press (Keiser) | 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) | 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) | 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) | 12 months after inclusion (approximately) |
| Muscular endurance (upper body) | Muscular endurance measured as correctly performed number of repetitions (push-ups) | 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) | 12 months after inclusion (approximately) |
| Functional fitness, six minutes step test | Functional fitness measured using the "six minutes step" test | 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 | 12 months after inclusion (approximately) |
| Muscle mass, DXA scan | Muscle mass measured using the whole-body DXA scan | Baseline to post-test (0-12 weeks) |
| Muscle mass, DXA scan (12-month follow-up) | Muscle mass measured using the whole-body DXA scan | 12 months after inclusion (approximately) |
| Visceral fat mass, DXA scan | Visceral fat mass measured using the whole-body DXA scan | 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 | 12 months after inclusion (approximately) |
| Fat mass, DXA scan | Fat mass measured using the whole-body DXA scan | Baseline to post-test (0-12 weeks) |
| Fat mass, DXA scan (12-month follow-up) | Fat mass measured using the whole-body DXA scan | 12 months after inclusion (approximately) |
| Bone mineral density, DXA scan | Bone mineral density measured using the whole-body DXA scan | 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 | 12 months after inclusion (approximately) |
| Muscle mass, ultrasound | Muscle mass measured using ultrasound to detect muscle thivkness of m.vastus lateralis | 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 | 12 months after inclusion (approximately) |
| Lipoprotein profile (subclasses of LDL, HDL) | Lipoprotein profile (subclasses of LDL, HDL) measured taking venous blood samples | 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 | 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 | 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 | 12 months after inclusion (approximately) |
| Fasting blood glucose | Fasting blood glucose measured in serum | Baseline to post-test (0-12 weeks) |
| Fasting blood glucose (12-month follow-up) | Fasting blood glucose measured in serum | 12 months after inclusion (approximately) |
| Glycated hemoglobin (HbA1c) | Long-term blood glucose control measured as glycated hemoglobin (HbA1c) in venous blood samples | 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 | 12 months after inclusion (approximately) |
| Waist circumference | Circumference of the waist measured using measuring tape | Baseline to post-test (0-12 weeks) |
| Waist circumference (12-month follow-up) | Circumference of the waist measured using measuring tape | 12 months after inclusion (approximately) |
| Glucose tolerance (c-peptide) | Oral glucose tolerance test (c-peptide) using venous blood samples | 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 | 12 months after inclusion (approximately) |
| Glucose tolerance (glucose) | Oral glucose tolerance test (glucose) using venous blood samples | Baseline to post-test (0-12 weeks) |
| Glucose tolerance (glucose) (12-month follow-up) | Oral glucose tolerance test (glucose) using venous blood samples | 12 months after inclusion (approximately) |
| Triglycerides | Triglycerides measured in venous blood samples | Baseline to post-test (0-12 weeks) |
| Triglycerides (12-month follow-up) | Triglycerides measured in venous blood samples | 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. | 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. | 12 months after inclusion (approximately) |
| C-reactive protein (CRP) | Systemic inflammation measured as C-reactive protein (CRP) concentration in venous blood samples. | 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. | 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. | 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. | 12 months after inclusion (approximately) |
| Hamar |
| Norway |
| Aktivklinikken | Lillehammer | Norway |
| Inland Norway University of Applied Sciences | Lillehammer | Norway |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |