Cancer
Conditions
Keywords
cancer rehabilitation, cancer survivors, resistance training, exercise adherence, home-based exercise, telerehabilitation, digital health, exercise oncology
Brief 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. 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.
Interventions
OTHERDigital follow-up
See the arm/group description.
OTHEROn-site follow-up
See the arm/group description.
BEHAVIORALResistance exercise
See the arm/group description.
Sponsors
Inland Norway University of Applied Sciences
Sykehuset Innlandet HF
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessment of all the outcomes will be performed in a blinded fashion by assessors/investigators.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* ≥ 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise adherence | Baseline to post-test (0-12 weeks) | Percentage of completed prescribed exercise sessions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustained exercise behaviour (12-month follow-up) | 12 months after inclusion (approximately) | 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. |
| Fatigue | Baseline to post-test (0-12 weeks) | 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. |
| Fatigue (12-month follow-up) | 12 months after inclusion (approximately) | 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. |
| Health-related Quality of Life: SF-36 questionnaire | Baseline to post-test (0-12 weeks) | 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. |
| Health-related Quality of Life: SF-36 questionnaire (12-month follow-up) | 12 months after inclusion (approximately) | 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. |
| Cancer-related quality of life | Baseline to post-test (0-12 weeks) | 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. |
| Cancer-related quality of life (12-month follow-up) | 12 months after inclusion (approximately) | 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. |
| Depression | Baseline to post-test (0-12 weeks) | 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. |
| Depression (12-month follow-up) | 12 months after inclusion (approximately) | 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. |
| Maximal muscle strength | Baseline to post-test (0-12 weeks) | Maximal muscle strength measured using one repetition maximum test (1RM) in leg press (Keiser) |
| Maximal muscle strength (12-month follow-up) | 12 months after inclusion (approximately) | Maximal muscle strength measured using one repetition maximum test (1RM) in leg press (Keiser) |
| Muscular endurance (legs) | Baseline to post-test (0-12 weeks) | Muscular endurance measured using correctly performed number of repetitions at 70% of 1RM in leg press (Keiser) |
| Muscular endurance (legs) (12-month follow-up) | 12 months after inclusion (approximately) | Muscular endurance measured using correctly performed number of repetitions at 70% of 1RM in leg press (Keiser) |
| Muscular endurance (upper body) | Baseline to post-test (0-12 weeks) | Muscular endurance measured as correctly performed number of repetitions (push-ups) |
| Muscular endurance (upper body) (12-month follow-up) | 12 months after inclusion (approximately) | Muscular endurance measured as correctly performed number of repetitions (push-ups) |
| Functional fitness, six minutes step test | Baseline to post-test (0-12 weeks) | Functional fitness measured using the "six minutes step" test |
| Functional fitness, six minutes step test (12-month follow-up) | 12 months after inclusion (approximately) | Functional fitness measured using the "six minutes step" test |
| Muscle mass, DXA scan | Baseline to post-test (0-12 weeks) | Muscle mass measured using the whole-body DXA scan |
| Muscle mass, DXA scan (12-month follow-up) | 12 months after inclusion (approximately) | Muscle mass measured using the whole-body DXA scan |
| Visceral fat mass, DXA scan | Baseline to post-test (0-12 weeks) | Visceral fat mass measured using the whole-body DXA scan |
| Visceral fat mass, DXA scan (12-month follow-up) | 12 months after inclusion (approximately) | Visceral fat mass measured using the whole-body DXA scan |
| Fat mass, DXA scan | Baseline to post-test (0-12 weeks) | Fat mass measured using the whole-body DXA scan |
| Fat mass, DXA scan (12-month follow-up) | 12 months after inclusion (approximately) | Fat mass measured using the whole-body DXA scan |
| Bone mineral density, DXA scan | Baseline to post-test (0-12 weeks) | Bone mineral density measured using the whole-body DXA scan |
| Bone mineral density, DXA scan (12-month follow-up) | 12 months after inclusion (approximately) | Bone mineral density measured using the whole-body DXA scan |
| Muscle mass, ultrasound | Baseline to post-test (0-12 weeks) | Muscle mass measured using ultrasound to detect muscle thivkness of m.vastus lateralis |
| Muscle mass, ultrasound (12-month follow-up) | 12 months after inclusion (approximately) | Muscle mass measured using ultrasound to detect muscle thivkness of m.vastus lateralis |
| Lipoprotein profile (subclasses of LDL, HDL) | Baseline to post-test (0-12 weeks) | Lipoprotein profile (subclasses of LDL, HDL) measured taking venous blood samples |
| Lipoprotein profile (subclasses of LDL, HDL) (12-month follow-up) | 12 months after inclusion (approximately) | Lipoprotein profile (subclasses of LDL, HDL) measured taking venous blood samples |
| Blood pressure at rest | Baseline to post-test (0-12 weeks) | Both systolic and diastolic blood pressure at rest measured using automated upper-arm blood pressure cuff |
| Blood pressure at rest (12-month follow-up) | 12 months after inclusion (approximately) | Both systolic and diastolic blood pressure at rest measured using automated upper-arm blood pressure cuff |
| Fasting blood glucose | Baseline to post-test (0-12 weeks) | Fasting blood glucose measured in serum |
| Fasting blood glucose (12-month follow-up) | 12 months after inclusion (approximately) | Fasting blood glucose measured in serum |
| Glycated hemoglobin (HbA1c) | Baseline to post-test (0-12 weeks) | Long-term blood glucose control measured as glycated hemoglobin (HbA1c) in venous blood samples |
| Glycated hemoglobin (HbA1c) (12-month follow-up) | 12 months after inclusion (approximately) | Long-term blood glucose control measured as glycated hemoglobin (HbA1c) in venous blood samples |
| Waist circumference | Baseline to post-test (0-12 weeks) | Circumference of the waist measured using measuring tape |
| Waist circumference (12-month follow-up) | 12 months after inclusion (approximately) | Circumference of the waist measured using measuring tape |
| Glucose tolerance (c-peptide) | Baseline to post-test (0-12 weeks) | Oral glucose tolerance test (c-peptide) using venous blood samples |
| Glucose tolerance (c-peptide) (12-month follow-up) | 12 months after inclusion (approximately) | Oral glucose tolerance test (c-peptide) using venous blood samples |
| Glucose tolerance (glucose) | Baseline to post-test (0-12 weeks) | Oral glucose tolerance test (glucose) using venous blood samples |
| Glucose tolerance (glucose) (12-month follow-up) | 12 months after inclusion (approximately) | Oral glucose tolerance test (glucose) using venous blood samples |
| Triglycerides | Baseline to post-test (0-12 weeks) | Triglycerides measured in venous blood samples |
| Triglycerides (12-month follow-up) | 12 months after inclusion (approximately) | Triglycerides measured in venous blood samples |
| Berg Balance Scale (BBS) | Baseline to post-test (0-12 weeks) | 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. |
| Berg Balance Scale (BBS) (12-month follow-up) | 12 months after inclusion (approximately) | 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. |
| C-reactive protein (CRP) | Baseline to post-test (12 weeks) | Systemic inflammation measured as C-reactive protein (CRP) concentration in venous blood samples. |
| C-reactive protein (CRP) (12-month follow-up) | 12 months after inclusion (approximately) | Systemic inflammation measured as C-reactive protein (CRP) concentration in venous blood samples. |
| Metabolic syndrome (collective assessment) | Baseline to post-test (12 weeks) | 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. |
| Metabolic syndrome (collective assessment) (12-month follow-up) | 12 months after inclusion (approximately) | 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. |
Countries
Norway
Contacts
PRINCIPAL_INVESTIGATORStian Ellefsen, Professor
Inland Norway University of Applied Sciences
STUDY_DIRECTORArne Kolstad, Professor
Sykehuset Innlandet HF
Outcome results
None listed