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.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
- 试验地点
- 5
- 主要终点
- Exercise adherence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessment of all the outcomes will be performed in a blinded fashion by assessors/investigators.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 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
排除标准
- •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.
研究组 & 干预措施
Digital home-based resistance exercise
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.
干预措施: Resistance exercise (Behavioral)
Digital home-based resistance exercise
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.
干预措施: Digital follow-up (Other)
On-site resistance exercise
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.
干预措施: On-site follow-up (Other)
On-site resistance exercise
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.
干预措施: Resistance exercise (Behavioral)
结局指标
主要结局
Exercise adherence
时间窗: From baseline to pre-test (0-12 weeks)
Percentage of completed prescribed exercise sessions.
次要结局
- Fatigue(From baseline to pre-test (0-12 weeks))
- Quality of life(From baseline to pre-test (0-12 weeks))
- Cancer related quality of life(From baseline to pre-test (0-12 weeks))
- Depression(From baseline to pre-test (0-12 weeks))
- Maximal muscle strength(From baseline to pre-test (0-12 weeks))
- Muscular endurance(From baseline to pre-test (0-12 weeks))
- Functional fitness, six minutes step test(From baseline to pre-test (0-12 weeks))
- Functional fitness, sit to stand test(From baseline to pre-test (0-12 weeks))
- Muscle mass, DXA scan(From baseline to pre-test (0-12 weeks))
- Visceral fat mass, DXA scan(From baseline to pre-test (0-12 weeks))
- Muscle mass, ultrasound(From baseline to pre-test (0-12 weeks))
- Lipoprotein profile (subclasses of LDL, HDL)(From baseline to pre-test (0-12 weeks))
- Blood pressure at rest(From baseline to pre-test (0-12 weeks))
- Fasting blood glucose(From baseline to pre-test (0-12 weeks))
- Hemoglobin glycosylation (HbA1c)(From baseline to pre-test (0-12 weeks))
- Waist circumference(From baseline to pre-test (0-12 weeks))
- Glucose tolerance (c-peptide)(From baseline to pre-test (0-12 weeks))
- Glucose tolerance (glucose)(From baseline to pre-test (0-12 weeks))
- Triglycerides(From baseline to pre-test (0-12 weeks))
研究者
Stian Ellefsen
Professor
Inland Norway University of Applied Sciences