The Impact of Short-term Exercise Programs on Mitochondrial Activity in Colorectal and Prostate Cancer Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Mitochondrial activity change with a short-term home-based exercise program
研究概览
简要总结
The aim is to investigate the impact of prostate and colorectal cancer on mitochondrial quantity and quality along with muscle mass and function and whether this can be modified through the use of a home-based short-term exercise training program.
The investigators aim to recruit participants awaiting curative surgery for colorectal and prostate cancer and to assess the variation in baseline mitochondrial activity between them.
Participants from both cancer types will then carry out a 4 week home exercise program, this will be randomly allocated to either resistance-based or high-intensity interval training based. Participants will then be re-assessed on the day of their planned surgical procedure to assess the changes effected by the training program.
The investigators hypothesize that there will be variation in mitochondrial activity linked to muscle mass across the two cancer types and that home-based exercise programs have the ability to improve mitochondrial activity along with muscle mass.
详细描述
Participants will be recruited from surgical outpatient clinics following an initial introduction to the trial by their clinical team. At this point, participants will be provided with a participant information sheet. Contact details will be provided on the information sheet to enable potential participants to arrange a screening visit. The screening visit would entail a detailed description of all study elements and addressing any questions prior to gaining written consent. Once the patient provides written informed consent, they will undergo a full cardiovascular examination by a medically qualified research team member and will have a set of screening bloods taken.
D2O Instructions 24 hours prior to the study day, participants will be asked to consume a stable isotope tracer drink (D2O) at a 3 ml/kg priming dose at home. Participants will be asked to provide saliva samples immediately prior to D2O consumption and a further sample 2-hours post-consumption. Participants will be provided with written instructions, the tracer drinks, and collection receptacles at their screening visit or via postal delivery for them to collect these samples at home. Participants will also be provided with a smaller maintenance dose (1.5ml/kg) to maintain D2O enrichment throughout the training program. This will need to be consumed once per week, with saliva collected immediately prior to, and 2-hours post-consumption each week - again, all materials and written instructions will be provided.
Pre-Exercise study day Participants will attend the University of Nottingham Graduate Entry Medical School at the Royal Derby hospital for an assessment visit prior to the commencement of their training protocol. Participants will be asked to arrive starved from 03:00 of the day, this is to match the nil-by-mouth rules required for their surgical procedure to ensure that all assessments are performed on the same fed-state. On arrival, they will undergo a limited number of physical function assessments (including time up and go, handgrip strength, and the short performance physical battery test).
Followed by the Ruffier test to provide an estimated cardiopulmonary fitness[14]. The ruffier test is performed by the participant resting for 5 minutes (lying down) then taking note of the resting heart rate. The participant then performs up to 30 standing squats within 45seconds, with a heart rate taken immediately upon completion. The participant then lies back down for 2 minutes with further heart rate measurement. This allows us to calculate the Ruffier Dicksons index which provides an estimated cardiopulmonary fitness[15].
Ruffier Dickson index (RDI): ((P1-70)+ 2(P2-P0))/10 Where P0 is 15 s average resting HR, in our case, from 3 min 45 s to 4 min, P1 is the maximum HR recorded during the first 15 s of recovery, and P2 is the 15 s average after the 1st minute of recovery, that is from 1 min and 00 s and 1 min and 15 s.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Due to the nature of the exercise interventions, there will be no masking
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 50 years and over (no upper age limit)
- •Male patients
- •Histologically confirmed malignancy, radiologically or direct visualisation leading to high clinical suspicion of cancer with planned surgical resection as treatment option (prostate or colorectal).
- •Sufficient mobility to be able to complete a home-based exercise program
- •Capacity to give informed and written consent
- •Ability to travel to the RDH to complete the assessment session
排除标准
- •Current participation in a formal exercise regime
- •Inability to complete exercise training
- •Inadequate level of the English language to be able to provide consent
- •A BMI <16.5 or >35 kg/m2
- •Active cardiovascular disease:
- •Uncontrolled hypertension (BP > 160/100)
- •Heart failure (class III/IV)
- •Significant arrhythmia
- •Right to left cardiac shunt
- •Recent cardiac event
- •Taking beta-adrenergic blocking agents
- •Cerebrovascular disease:
- •g. Previous stroke h. Aneurysm (large vessel or intracranial) i. Epilepsy
- •Respiratory disease including:
- •j. Pulmonary hypertension k. Significant COPD l. Uncontrolled asthma
- •Clotting dysfunction or current use of anticoagulants (eg Warfarin/Clopidogrel/ Rivaroxaban)
- •Significant musculoskeletal or neurological disorders
- •Female patients
- •Those requiring or receiving neoadjuvant chemotherapy
研究组 & 干预措施
Resistance exercise training group
Participants randomized to this arm will engage in a 4-week home-based training program with anticipated 12 sessions (3 per week) with participants required to attend a minimum of 9 sessions.
干预措施: Resistance exercise training (Other)
High-intensity interval training group
Participants randomized to this arm will engage in a 4-week home-based training program with anticipated 12 sessions (3 per week) with participants required to attend a minimum of 9 sessions.
干预措施: High-intensity interval training (Other)
结局指标
主要结局
Mitochondrial activity change with a short-term home-based exercise program
时间窗: Assessed over the 4-weeks prior to planned surgical resection
The effect of either a resistance exercise-based and high-intensity interval training-based home-based training program on mitochondrial function. Mitochondrial oxidative phosphorylation capacity will be measured according to oxygen consumption determined by the use of a high-definition respirometer. The changes seen throughout the treatment will then be expressed as a percentage in order to express the changes seen from the baseline.
Mitochondrial activity across 2 cancer types
时间窗: Assessed at initial baseline study day across cancer types
Mitochondrial oxidative phosphorylation capacity between colorectal and prostate cancer. Mitochondrial oxidative phosphorylation capacity will be measured according to oxygen consumption determined by the use of a high-definition respirometer. This will then be compared across cancer types and expressed as a ratio of maximal consumption.
The altered response to training - type between cancer type.
时间窗: 4-weeks
The differing responses between cancer type to the short-term exercise training. Mitochondrial oxidative phosphorylation capacity will be measured according to oxygen consumption determined by the use of a high-definition respirometer. The changes caused by the training regimen will then be expressed as a percentage in order to express the changes seen from the baseline, and in order to allow comparison between cancer type.
次要结局
- The effect of cancer types and exercise on myokine expression.(4-weeks)
- The difference in muscle-function compared between cancer types, and its change throughout a short-term exercise program.(4-weeks)