A Comparison of Aerobic and Resistance Exercise for Counteracting the Adverse Effects of Androgen Deprivation Therapy in Men With Prostate Cancer
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Feasibility- exercise program adherence through attendance %.
研究概览
简要总结
Prostate cancer is the second most common cancer in men. Those in the intermediate/high-risk categories typically receive androgen deprivation therapy (ADT) and radiotherapy. ADT greatly reduces androgen production as prostate cancer is dependent on testosterone and dihydrotestosterone for its growth.The side effects of ADT therapy are extensive and include changes in body composition (muscle loss, bone loss and fat gain), strength, mood, physical function, sexual function and increased cardiovascular risk and fatigue. Many of these side effects can be influenced by exercise training, both resistance training and aerobic training. However, the most appropriate exercise regime for men undergoing ADT has received little research attention.
详细描述
Although many interventions for prostate survivors emphasise resistance exercise to maintain muscle mass and strength. Arguments could equally be made for programmes emphasising aerobic exercise for fatigue, anxiety, cardiovascular risk reduction and indeed overall survival.
Comparisons of programmes that emphasise each exercise mode are clearly required.
Therefore the overall purpose of this feasibility and pilot randomised control trial is to determine the feasibility and preliminary effectiveness of an aerobic emphasised exercise program (AE) verses a resistance emphasise exercise program (RE) in a rehabilitation setting, over 6 months, for prostate cancer men undergoing Androgen Deprivation Therapy (ADT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •>18 years of age with a histologically diagnosed prostate cancer
- •Prescribed ADT (Androgen deprivation Therapy)
- •Self-reported not to be partaking in regular exercise (structured aerobic or resistance training ≥ 2 sessions/week) in the past 3 months.
- •Medically cleared to exercise by their oncologist
排除标准
- •Prior exposure to ADT >12 months
- •Prior hypogonadism
- •Established metastatic bone disease
- •Established Osteoporosis
- •Musculoskeletal/Cardiovascular and/or Neurological disease that could put them at risk from exercise as judged by the attending physician.
结局指标
主要结局
Feasibility- exercise program adherence through attendance %.
时间窗: Throughout 24 week intervention
The research team will report adherence to the exercise program through attendance of supervised classes. Attendance will be reported as a percentage.
Feasibility- recruitment rate (%)
时间窗: At study conclusion
The recruitment rate will be established by comparing the number of potential participants approached and how many agreed to participate in the trial. This will be reported in percentage format.
Feasibility- Adverse Event using CTCAE v4.0 grading system.
时间窗: At study conclusion
The research team will report any adverse events in general or in relation to the exercise program using CTCAE v4.0 grading system.
Feasibility- Patient satisfaction/acceptability through qualitative evaluation.
时间窗: Following intervention conclusion at 24 weeks
Determined by qualitative evaluation, using semi structured interviews and exit surveys to evaluate the acceptability, experiences and feasibility of the intervention.
Feasibility- exercise prescription adherence (% of modified sessions compared to attended exercise sessions)
时间窗: Throughout 24 week intervention
The research team will report adherence to the exercise prescription by reporting the number of modified sessions compared to attended exercise sessions. This will be reported as a percentage.
Feasibility- retention rate (%)
时间窗: Intervention conclusion 24 weeks
Percentage of participants that completed the 24 week intervention compared to the number of participants randomised. This will be reported in percentage format.
次要结局
- Physical Activity (subjective) by questionnaire(At baseline, 8 weeks and 24 weeks (end of intervention))
- Anthropometric assessment.(At baseline and 24 weeks (end of intervention))
- General quality of life by questionnaire(At baseline, 8 weeks and 24 weeks (end of intervention))
- Body composition (fat mass) analysis using Dual Energy X Ray Absorptiometry (Dexa)(At baseline and 24 weeks (end of intervention))
- Bone density (BMD) measurement(At baseline and 24 weeks (end of intervention))
- Atrial stiffness measured by a Pulse Wave Velocity Assessment (m/s)(At baseline and 24 weeks (end of intervention))
- Functional Ability Assessment (Sit to stand)(At baseline, 8 weeks and 24 weeks (end of intervention))
- Functional Ability Assessment (Grip test)(At baseline, 8 weeks and 24 weeks (end of intervention))
- Prostate cancer specific quality of life by questionnaire(At baseline, 8 weeks and 24 weeks (end of intervention))
- Fatigue by questionnaire(At baseline, 8 weeks and 24 weeks (end of intervention))
- Visceral fat area (VAT Area) in cm(squared)(At baseline and 24 weeks (end of intervention))
- Peak torque/power for knee extension and flexion(At baseline and 24 weeks (end of intervention))
- Lower limb strength [Leg Press](At baseline and 24 weeks (end of intervention))
- Upper limb strength [Chest Press](At baseline and 24 weeks (end of intervention))
- Functional Ability Assessment (Timed up and go)(At baseline, 8 weeks and 24 weeks (end of intervention))
- Cancer Specific quality of life by questionnaire(At baseline, 8 weeks and 24 weeks (end of intervention))
- Waist and Hip circumference analysis (cms)(At baseline and 24 weeks (end of intervention))
- Blood pressure (mmHg)(At baseline and 24 weeks (end of intervention))
- Cardiovascular Fitness(0(baseline), 8 weeks and 6 months (end of intervention))
- Functional Ability Assessment (6 minute walk test)(At baseline, 8 weeks and 24 weeks (end of intervention))
- Biomarker Analysis: C-Reactive Protein (CRP)(At baseline and 24 weeks (end of intervention))
- Body composition (fat and lean mass) analysis using Dual Energy X Ray Absorptiometry (Dexa)(At baseline and 24 weeks (end of intervention))
- Functional Ability Assessment (Bess Balance test)(At baseline, 8 weeks and 24 weeks (end of intervention))
- Functional Ability Assessment (Sit and reach)(At baseline, 8 weeks and 24 weeks (end of intervention))
- Biomarker Analysis: Blood lipids (mmol/L)(At baseline and 24 weeks (end of intervention))
- Biomarker Analysis: Glucose (mmol/L)(At baseline and 24 weeks (end of intervention))
- Biomarker Analysis: Insulin (mIU/L)(At baseline and 24 weeks (end of intervention))
研究者
Kira Murphy
Research Coordinator
Waterford Instituate of Technology