ZMoveMent-1: Effect of a Resistance and Aerobic Training Intervention on Quality of Life, Fitness, Immunological Parameters, and Oncological Outcome in Patients With Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change from Baseline in the Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire Score
研究概览
简要总结
Prostate cancer is the second most common cancer among men. Many patients experience a significantly reduced quality of life due to either the cancer itself or the side effects of treatment. These side effects can include tiredness, weight gain, loss of muscle and strength, bone weakness, depression, reduced sexual function, and increased risk of heart problems. A commonly used treatment called androgen deprivation therapy, which reduces the levels of male hormones, can make these symptoms worse.
Previous research has shown that physical exercise-both strength training and endurance training-can help improve physical and mental well-being in men with prostate cancer. Regular exercise has also been shown to improve body composition, cardiovascular health, and reduce cancer-related fatigue. Some studies even suggest that exercise might support the immune system and slow down the progression of cancer.
The aim of this clinical trial is to find out whether a specific combination of resistance and aerobic training can help improve quality of life and health outcomes in men with prostate cancer. The exercise program is designed to be performed at home using simple equipment like resistance bands and bodyweight exercises, along with high-intensity interval training for endurance. Participants are asked to train three to six days a week.
150 men with prostate cancer at various stages of the disease will be included. These men will be randomly divided into two groups: two-thirds will receive the exercise program (intervention group), and one-third will continue with their usual care without the program (control group). The initial training period lasts 12 weeks and will be repeated to ensure that all participants in the exercise group train for at least six months. After that, they will be encouraged to keep training on their own.
The main goal of the study is to see if the exercise program leads to improvements in quality of life, physical fitness, body composition, and markers of immune function. It will also be analyzed how well the participants stick to the program, whether a longer training period has more benefits, how physically active the participants are overall, and how the program might affect other health and cancer-related outcomes.
The underlying hypothesis is that a structured, home-based resistance and aerobic training program will improve quality of life, physical fitness, body composition, immune function, and possibly cancer-related outcomes in men with prostate cancer.
详细描述
This study is a two-arm open-label controlled trial that aims to investigate the effects of combined resistance and aerobic training on quality of life (QoL), body composition, fitness parameters, immunological parameters, and oncological outcomes in patients with prostate cancer (PC).
150 men will be recruited with either localized, locally advanced, or metastatic PC. Patients will be randomly assigned in a 2:1 ratio to either the intervention arm (guided home-based training) or the standard of care (SOC) arm (self-directed or no exercise). Prior to enrollment, participants will provide written informed consent, undergo clinical eligibility confirmation, and complete screening assessments. Owing to the already documented general health benefits of exercise in patients with PC, participants randomized to the SOC arm will be informed about the benefits of exercise as well, and will be motivated to engage in exercise under their own management (self-directed exercise). Changes in physical activity will be monitored in both groups.
This study will include a screening phase, a 12-week intervention phase, a post-12-week intervention phase, and a longer-term intervention phase.
During the screening phase (maximally 35 days prior to the first training session), participants will undergo assessments to determine their eligibility for the study. This involves evaluating inclusion and exclusion criteria, as well as data collection on demographics and tumor stage. To avoid bias and to ensure equal participation and motivation of participants from both the intervention and the SOC arm in the baseline tests, patient randomization will only take place after the baseline testing.
The 12-week intervention phase comprises the initial 12 weeks of a home-based combined resistance and aerobic training protocol for the intervention arm. Training will commence 8 weeks (when medically cleared, a reduction to minimally 4 weeks is possible) after radical prostatectomy (RP) or completion of external-beam radiotherapy (EBRT), or any time for PC patients undergoing systemic treatment. As part of their visit for baseline testing, participants will be familiarized with the online platform incorporating the training program, including the correct execution of the exercises. In addition, the online platform includes demonstration videos of all exercises. The control arm will receive SOC without any exercise prescriptions. Throughout the phase, participants' physical activity will be monitored using regular questionnaires and wearable device data. Efficacy evaluations will be conducted at baseline and after the 12-week intervention phase.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Participant must have a histologically diagnosed adenocarcinoma of the prostate
- •Participant has to be ≥ 18 years of age
- •Participant must have either localized, locally advanced, or metastatic PC which has been treated or is planned to be treated either by RP, EBRT, androgen deprivation therapy (ADT), androgen receptor signaling inhibitor (ARSI), or any combination
- •Participant must understand and remember the training regimen
- •Participant must have a smartphone to connect a wearable device
- •Participant must have a smartphone or computer to access the online platform
- •Participant has to be able to speak, understand, and read German or English
- •Participant must sign an informed consent form (ICF)
排除标准
- •Cardiovascular/neurological/musculoskeletal comorbidities with contraindications for resistance or aerobic training
- •High risk of pathological fracture due to unstable bone metastases (note: patients with bone metastasis are generally eligible for participation in the study and program as long as there is no acute high risk of fracture)
- •Any condition for which it may not be in the best interest of the patient to participate in the study
研究组 & 干预措施
Standard of Care
The control arm will receive SOC, as well as a booklet with general information and guidelines about physical activity in prostate cancer patients, but without any specific exercise prescriptions.
干预措施: Standard of Care (Behavioral)
Structured Training
The 12-week intervention phase comprises the initial 12 weeks of a home-based combined resistance and aerobic training protocol for the intervention arm. Training will commence 8 weeks (when medically cleared, a reduction to minimally 4 weeks is possible) after RP or completion of EBRT, or any time for PC patients undergoing systemic treatment. As part of their visit for baseline testing, participants will be familiarized with the online platform incorporating the training program, including the correct execution of the exercises. In addition, the online platform includes demonstration videos of all exercises.
干预措施: Structured combined resistance and aerobic training (Behavioral)
结局指标
主要结局
Change from Baseline in the Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire Score
时间窗: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
Range of 0-156 points. Higher points mean higher QoL.
Change from Baseline in Total Muscle Thickness (TMT)
时间窗: Baseline and after 12-week intervention phase
Muscle Thickness (MT) will be measured via ultrasound (linear head held perpendicular to the skin) at 4 sites (anterior and posterior upper arm, anterior and lateral thigh). For the primary outcome, the sum of those 4 sites will be used (TMT), but the separate results will also be reported. The measurement protocol used is adapted from Schoenfeld et al. (2019): https://doi.org/10.1249/MSS.0000000000001764
Change from Baseline in Serum Low-Density Lipoprotein (LDL) in milligrams/deciliter (mg/dl)
时间窗: Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase
次要结局
- Change from baseline in daily caloric expenditure by activity in calories/day, measured by wearable device(Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase)
- Adherence to the training program(Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase)
- Adverse Events by Questionnaire(After 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase)
- Change from baseline in blood insulin-like growth factor (IGF-1) level in ng/ml(Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase)
- Change from baseline in the Metabolic Equivalent of Task (MET)-minutes/week as reported by the World Health Organization (WHO) Global Physical Activity Questionnaire (GPAC) Questionnaire Score(Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase)
- Change from Baseline in Blood Pressure (systolic and diastolic)(Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase)
- Change from Baseline in the Short Form 36 (SF-36) Questionnaire Subscale Scores(Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase)
- Change from Baseline in the International Index of Erectile Function (IIEF) Questionnaire Score(Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase)
- Change from baseline in resting heart rate (RHR) in beats per minute (bpm), measured by wearable device(Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase)
- Change from baseline in daily step count in steps/day, measured by wearable device(Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase)
- Change from baseline in daily sleep duration in hours (h), measured by wearable device(Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase)
- Change from baseline in blood glucose level in mg/dl(Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase)
- Change from baseline in blood creatinine level in mg/dl(Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase)
- Change from baseline in blood C-reactive protein (CRP) level in mg/dl(Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase)
- Change from baseline in blood alcaline phosphatase (AP) level in units/liter (U/l)(Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase)
- Change from baseline in blood lactate dehydrogenase (LDH) level in U/l(Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase)
- Change from baseline in blood total cholesterole level in mg/dl(Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase)
- Change from Baseline in the Expanded Prostate Cancer Index Composite (EPIC) Questionnaire Subscale Scores(Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase)
- Change from baseline in bodyweight in kilograms (kg)(Baseline and after 12-week intervention phase)
- Change from Baseline in the Pittsburgh Sleep Quality Index (PSQI) Questionnaire Score(Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase)
- Change from Baseline in the Decision Regret Scale (DRS) Questionnaire Score(Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase)
- Change from baseline in body mass index (BMI) in kg/(m^2)(Baseline and after 12-week intervention phase)
- Change from baseline in hip- and waist circumference in cm(Baseline and after 12-week intervention phase)
- Change from baseline in muscle thickness (MT) at anterior upper arm, posterior upper arm, anterior thigh, and lateral thigh(Baseline and after 12-week intervention phase)
- Change from baseline in Short Physical Performance Battery (SPPB) Test Score(Baseline and after 12-week intervention phase)
- Change from baseline in Timed Up And Go Test (TUGT) in seconds(Baseline and after 12-week intervention phase)
- Change from baseline in grip strength test in newton/kilograms(Baseline and after 12-week intervention phase)
- Change from baseline in blood high-density lipoprotein (HDL) level in mg/dl(Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase)
- Change from baseline in blood white blood cell (WBC) count in giga/liter (G/l)(Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase)
- Change from baseline in blood prostate-specific antigen (PSA) level in ng/ml(Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase)
- Change from baseline in blood interleukin-6 (IL-6) level in picogram/ml (pg/ml)(Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase)
- Change from baseline in blood hemoglobin in grams/deciliter (g/dl)(Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase)
- Change from baseline in blood platelet count in G/l(Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase)
- Change from baseline in blood testosterone level in ng/ml(Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase)
- Change from baseline in blood sex-hormone binding globulin (SHBG) level in nanomole/liter (nmol/l)(Baseline, after 12-week intervention phase and 3/6/12 months after completion of 12-week intervention phase)
研究者
Shimon Kempin
Principal Investigator
Ludwig-Maximilians - University of Munich