Onco Move - Improvement of Psychophysical Fitness in Adult Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Assessed changes from baseline Health-Related Quality of Life (HRQOL)
研究概览
简要总结
The Onco Move project aims to assess the impact of a 16-week supervised multicomponent group exercise training program on the psychophysical well-being of individuals undergoing or recovering from cancer treatment. A total of 70 participants, aged 18-55, with various types of cancer, will be recruited for the study. Participants will be randomly assigned to either an experimental group (which will engage in the Onco Move exercise program) or a control group (usual care). Baseline measurements will be taken to assess their psychological, physiological, functional, and biochemical health. These tests will help determine the initial psychophysical health levels and the quality of life of the participants.The experimental group will undergo group exercise sessions three times a week at the Gdansk University of Physical Education and Sport, led by certified fitness instructors. The study will assess the effects of the program at three different time points: after 8 weeks, after 16 weeks, and 3 months after the completion of the program. The main objective is to investigate how regular Onco Move training influences the physical and psychological health of cancer patients, including their overall functional status, fitness, and quality of life.The findings will provide valuable insights into the positive psychophysical effects of group exercise training for cancer patients and contribute to developing a set of recommended physical activity and exercise forms for oncology patients during and after treatment. Additionally, the results will help in the creation of guidelines for recommending psychophysical exercises that could aid recovery and improve the quality of life for cancer patients.
详细描述
The Onco Move Project is designed to assess the effects of a 16-week supervised group exercise multicomponent program on the psychophysical well-being of individuals undergoing or recovering from cancer treatment. The study will involve 70 participants aged between 18 and 55 years, representing a diverse sample with different cancer types. The participants will be randomly assigned to one of two arms: the experimental group, which will participate in the Onco Move exercise program, or the control group, which will not engage in the exercise intervention. The primary objective of the study is to investigate how regular participation in the Onco Move exercise program affects various aspects of the participants' physical and psychological health. These aspects include overall functional status, fitness levels, and quality of life. The study will assess the impact of the training on multiple parameters, such as psychological health (e.g., anxiety, depression, and stress), physical function or health-related fitness (e.g., muscular strength, cardiorespiratory fitness, balance and body composition), autonomy (e.g., ability to perform daily activities) and biomarkers associated with inflammation, muscle recovery, and overall metabolic function, as well as genetic markers, which will help evaluate individual variability in response to the intervention and provide insights into genetic influences on inflammation, metabolism, muscle adaptation, and cellular aging.
By examining these outcomes, the study aims to provide new insights into how structured physical exercise can benefit cancer patients during and after treatment. This information could serve as the foundation for developing guidelines for recommending specific exercise programs tailored to oncology patients' needs. A total of 70 participants will be recruited for the study. Participants will be carefully selected to include individuals between the ages of 18 and 55 who have undergone or are currently undergoing cancer treatment. They will represent a variety of cancer types to ensure that the findings are applicable across different patient populations. Prior to participation, baseline measurements will be conducted to assess their psychological, physiological, functional, and biochemical health status.After the baseline assessment, participants will be randomly assigned to one of two arm: 1) Experimental group: This group will participate in the Onco Move exercise program, which involves supervised group exercise sessions held three times per week. 2) Control group: Participants in the control group will not engage in the Onco Move program but will continue their usual activities/care and they will get physical activity recommendations. They will receive general wellness advice and physical activity recommendations but will not be prescribed any specific physical exercise training during the study period.
The Onco Move exercise program is specifically designed for cancer patients and will include a combination of aerobic, strength, flexibility, and coordination/balance exercises. The exercise training sessions will be adapted to participants' individual fitness levels and will progress in load/intensity throughout the 16 weeks. The program aims to: (1) Improve aerobic capacity and muscular strength; (2) Enhance flexibility, coordination/balance, and mobility; (3) Reduce fatigue and improve mood; (4) Promote a sense of empowerment and increase overall physical activity levels. Sessions will be held three times a week, with each session lasting approximately 60 minutes (volume parameter). The exercise program will be personalized and tailored to the needs and abilities of each participant, ensuring that they engage in safe and effective exercises that are suitable for their current level of function. All sessions will be supervised by certified fitness instructors who are trained to work with individuals recovering from cancer treatment.
The impact of the Onco Move program will be evaluated at four time points during the study: (1) At the baseline; (2) After 8 weeks of participation in the exercise program; (3) After 16 weeks, at the completion of the exercise program; and (4) Three months after the completion of the program, to assess the longer-term effects of the intervention. At each time point, participants will undergo a comprehensive evaluation, including psychological, physiological, and functional assessments, as well as biochemical testing to measure specific health markers. These time points will help determine the immediate and sustained effects of the fitness program on participants' well-being.The study will use a variety of outcome measures to assess the impact of the Onco Move program. These include: (1) Physical fitness tests: A series of tests designed to assess strength, balance, flexibility, and cardiorespiratory fitness, including the Senior Fitness Test (SFT) and Short Physical Performance Battery (SPPB); (2) Psychological assessments as tools to assess anxiety, depression, stress, and quality of life, such as the Four-Item Patient Health Questionnaire For Anxiety And Depression (PHQ-4) and various scales measuring mood, sexual function, and general health-related quality of life; (3) Biochemical markers, blood samples will be analyzed to measure biomarkers such as IL-6, IL-15, Irisin, BDNF, SPARC, and decorin, which are associated with inflammation, muscle health, and overall physical recovery; (4) Genetic analyses will include polymorphisms located in the following genes: ACE, ACTN3, PPARGC1A, BDNF, VEGF, IL6, NOS3, HIF1A, TNF-α, mTOR pathway, telomeres, and telomerase; (5)Self-Reported Fitness: Participants' subjective assessments of their fitness will be recorded using tools such as the International Fitness Scale (IFIS).
The Onco Move project has the potential to make significant contributions to the field of cancer exercise research. By investigating the psychophysical effects of physical exercise training, the study will provide evidence-based insights into the benefits of structured physical exercise for cancer patients. These findings could lead to the development of guidelines for oncology professionals, helping them to recommend appropriate physical exercise during and after treatment. Furthermore, the study will help shape future exercise programs and improve quality of life for cancer survivors by promoting physical exercise as a central component of post-treatment recovery.The results of this study may also pave the way for health policy changes that encourage the integration of exercise interventions into standard cancer care practices, improving outcomes and empowering cancer survivors to take control of their physical and psychological health. By carefully assessing the effects of the Onco-Move program on various health parameters, the study aims to contribute valuable evidence that will guide the development of personalized and tailored physical exercise interventions for cancer patients. Ultimately, the project seeks to enhance the overall well-being of cancer patients and survivors, improve their quality of life, and provide a foundation for future exercise interventions in oncology care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to
- •Currently undergoing cancer treatment or up to 5 years post-treatment.
- •Individuals with various types of cancer.
- •Participants who have been physically inactive and have led a sedentary lifestyle since diagnosis.
- •Both genders, with no requirement for equal distribution between women and men.
- •Participants who commit to attending three training sessions per week.
- •Oncologist's approval for participation in the project.
- •Signed informed consent from the patient to participate in the study and consent for personal data processing.
排除标准
- •Age below 18 or above 55 at the time of registration for the project.
- •Physically active individuals.
- •Health conditions preventing continued participation in the study or intervention.
- •Participants who do not commit to attending three training sessions per week.
- •Lack of oncologist's approval for participation in the study and training activities outlined in the project.
- •Lack of signed informed consent for participation in the study and consent for personal data processing.
- •Pregnant women*.
- •Pregnant women who wish to participate in the project will be allowed to attend a free lecture on the guidelines from the World Health Organization and the American College of Sports Medicine regarding recommended physical activity for cancer patients.
结局指标
主要结局
Assessed changes from baseline Health-Related Quality of Life (HRQOL)
时间窗: From enrolment to 3 months after the intervention
HRQOL will be assessed pre-, post-intervention, and at follow-up using validated questionnaire: European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire-Core 30 (EORTC QLQ-C30). This instrument measures general quality of life and includes multiple subscales (e.g. physical, emotional, cognitive functioning). Scores on each scale range from 0 to 100. * For functional scales and global health status, higher scores indicate better functioning or QoL. * For symptom scales/items, higher scores indicate more severe symptoms (i.e. worse outcomes). Data will be collected via digital or paper formats and analyzed. Statistical methods include repeated measures ANOVA and linear mixed-effects models to detect changes over time. Missing data will be handled via multiple imputation. This approach provides a comprehensive assessment of psychological and functional well-being related to the intervention.
次要结局
- Change in female sexual function, assessed by Female Sexual Function Index (FSFI)(From enrolment to 3 months after the intervention)
- Change in male sexual function, assessed by International Index of Erectile Function (IIEF)(From enrolment to 3 months after the intervention)
- Change in mood states, assessed by UWIST Mood Adjective Checklist (UMACL)(From enrolment to 3 months after the intervention)
- Change in perceived stress, assessed by The Feeling of Stress Questionnaire (KPS)(From enrolment to 3 months after the intervention)
- Change in anxiety and depression symptoms, assessed by the Four-Item Patient Health Questionnaire For Anxiety And Depression (PHQ-4)(From enrolment to 3 months after the intervention)
- Change in personality traits, assessed by NEO Five-Factor Inventory (NEO-FFI)(From enrolment to 3 months after the intervention)
- Change in state and trait anxiety, assessed by State-Trait Anxiety Inventory (STAI)(From enrolment to 3 months after the intervention)
- Change in lower limb strength, assessed by Chair Stand Test (from Short Physical Performance Battery and Senior Fitness Test)(From enrolment to 3 months after the intervention)
- Change in upper limb strength, assessed by Arm Curl Test (from SFT)(From enrolment to 3 months after the intervention)
- Change in flexibility, assessed by Toe Touch and Back Scratch Tests (from SFT)(From enrolment to 3 months after the intervention)
- Change in aerobic capacity, assessed by 6-Minute Walk or 2-Minute Step Test (from SFT)(From enrolment to 3 months after the intervention)
- Change in balance and agility, assessed by 8-Foot Up-and-Go Test (from SF)(From enrolment to 3 months after the intervention)
- Change in balance, assessed by Standing Balance Test (from SPPB)(From enrolment to 3 months after the intervention)
- Change in walking speed, assessed by 4-Meter Walk Test (from SPPB)(From enrolment to 3 months after the intervention)
- Change in pain threshold, assessed by AlgoMed Algometer(From enrolment to 3 months after the intervention)
- Change in pain tolerance, assessed by AlgoMed Algometer(From enrolment to 3 months after the intervention)
- Change in subjective pain intensity, assessed by Visual Analogue Scale (VAS)(From enrolment to 3 months after the intervention)
- Change in pain characteristics, assessed by Laitinen Pain Scale(From enrolment to 3 months after the intervention)
- Change in body weight, assessed by InBody 720 Bioimpedance Analyzer(From enrolment to 3 months after the intervention)
- Change in body fat percentage, assessed by InBody 720 Bioimpedance Analyzer(From enrolment to 3 months after the intervention)
- Change in skeletal muscle mass, assessed by InBody 720 Bioimpedance Analyzer(From enrolment to 3 months after the intervention)
- Change in Body Mass Index (BMI), calculated from InBody 720 measurements(From enrolment to 3 months after the intervention)
- Change in visceral fat area, assessed by InBody 720 Bioimpedance Analyzer(From enrolment to 3 months after the intervention)
- Baseline Self-Reported Physical Fitness (IFIS) vs. InBody 720(At the baseline)
- Assessed changes from baseline postural stability and balance control(From enrolment to 3 months after the intervention)
- Assessed changes from baseline neuromuscular function (isokinetic dynamometry)(From enrolment to 3 months after the intervention)
- Assessed changes from baseline cardiopulmonary fitness (ergospirometry)(From enrolment to 3 months after the intervention)
- Assessed changes from baseline lower limb power and force (vertical and horizontal jumping)(From enrolment to 3 months after the intervention)
- Assessed changes from baseline grip strength(From enrolment to 3 months after the intervention)
- Assessed changes from baseline blood lactate levels(From enrolment to the the end of the intervention)
- Change in serum concentration of Interleukin-6 (IL-6)(From enrolment to 3 months after the intervention])
- Change in serum concentration of Interleukin-15 (IL-15)(From enrolment to 3 months after the intervention)
- Change in serum concentration of Irisin(From enrolment to 3 months after the intervention)
- Change in serum concentration of Brain-Derived Neurotrophic Factor (BDNF)(From enrolment to 3 months after the intervention)
- Change in serum concentration of SPARC (Secreted Protein, Acidic and Rich in Cysteine)(From enrolment to 3 months after the intervention)
- Change in serum concentration of Decorin(From enrolment to 3 months after the intervention)
- Distribution of ACE Gene Polymorphisms(At the baseline)
- Distribution of ACTN3 Gene Polymorphisms(At the baseline)
- Distribution of PPARGC1A Gene Polymorphisms(At the baseline)
- Distribution of BDNF Gene Polymorphisms(At the baseline)
- Distribution of VEGF Gene Polymorphisms(At the baseline)
- Distribution of IL6 Gene Polymorphisms(At the baseline)
- Distribution of NOS3 Gene Polymorphisms(At the baseline)
- Distribution of HIF1A Gene Polymorphisms(At the baseline)
- Distribution of TNF-α Gene Polymorphisms(At the baseline)
- Distribution of mTOR Pathway Gene Polymorphisms(At the baseline)
- Change in relative telomere length and telomerase activity(From enrolment to 3 months after the intervention)
- Adherence to the mediterranean diet assessed by the 14-Item MEDAS Questionnaire(From Baseline up to 3 months after the intervention)
