A Pilot Study of Moderate Intensity Exercise as Adjuvant Therapy in the Management of Brain and Central Nervous System Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- 6 minute walk test.
研究概览
简要总结
With a trend for increased survival in patients with Brain and Central Nervous System (CNS) cancers, emphasis is increasingly shifting to improving the quality of life of survivors. Performance status (a quantification tool used in patients with cancer to assess their quality of life and ability to carry out activities of daily living) is a key prognostic factor in Brain and CNS cancers and a good performance status is used in determining whether a patient is offered adjuvant treatment with chemotherapy and radiotherapy following primary surgical treatment. The performance status of a patient is defined by physical and cognitive functioning, and the beneficial effect of aerobic exercise in improving physical functioning (e.g., cardiorespiratory fitness) is well established. Thus, it is anticipated that implementing a supervised moderate intensity aerobic exercise training programme will improve the performance status of patients. An implication of this work is that, exercise regimens could be offered as additional treatment, alongside chemotherapy and radiotherapy, which might increase the chance of survival.
The project design is a randomised controlled trial with two arms in which one group of patients will undergo an aerobic exercise program starting one week before surgery and continuing for three weeks in the post-operative period. Patients enrolled in this trial will continue with standard treatment including neuro-rehabilitation. The control group of patients will be given written instructions on performing flexibility and stretching exercises in addition to their usual care (including neuro-rehabilitation). The primary outcome is performance status as defined by measurements of physical functioning and cognitive ability (e.g., memory, attention, information processing speed). Physical functioning will be assessed by a timed walking test, hand-grip dynamometry and a maximum jump height test. Other measures of well-being will be assessed; including heath related quality of life using the European Quality of Life-5 Dimensions (EQ-5D) and Functional Assessment of Cancer Therapy- Brain (FACT-Br) questionnaires. Secondary outcome measures will be measurements of mood, fatigue and certain biochemical parameters, such as C-reactive protein (CRP), plasma viscosity (PV), full blood count (FBC), uric acid, insulin-like growth factor 1 (IGF-1), and insulin-like growth factor binding protein 3 (IGFBP-3). It is anticipated that a total of 30 patients will be recruited split between the two groups and each participant will not spend more than four weeks in taking part in the study.
详细描述
Study design:
Randomised controlled trial. Participants will be randomised into one of two groups: intervention or control. Participants in the intervention group will undergo a supervised moderate intensity aerobic exercise programme in addition to routine treatment starting 1 week after their primary treatment (surgery/radiotherapy) for 3 weeks.
Participants in the control group will undergo a programme involving muscle stretching (flexibility) exercises using a combination of active and passive static stretching to target the major muscle tendon units of the neck, shoulder girdle, chest, trunk, lower back, hips, legs (posterior and anterior aspects) and ankles over the same time period as the intervention group. The exercises in this group will be unsupervised. Patients will be provided with written clear instructions listing the stretches to perform. These written instructions will be supplemented with diagrams for each stretch manoeuvre.
Research setting:
The project will be based within the premises of the Hull and East Yorkshire hospital NHS Trust. This is an acute care tertiary centre based over two hospital sites: the Hull Royal Infirmary (HRI) and Castle Hill Hospital (CHH). The neurosurgical ward and operating theatres are based at the HRI site while the inpatient specialist rehabilitation ward and the oncology facilities and clinicians are based at the Queens Centre for Oncology/Haematology within the premises of CHH. The neurosurgery outpatient clinic is also based at CHH site. The facilities and equipment for the exercise intervention will be based in a dedicated specialist inpatient rehabilitation unit on ward 29 at the Queens centre. The Queens Centre is a purpose built oncological facility that co-locates all of the services (including psychology) involved in cancer care apart from surgical services. This protocol and proposal has been utilised in making ethics submission across 2 institutions- the University of Bath and the Hull and East Yorkshire Hospital NHS Trust hosting the study setting.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (aged 18 years plus).
- •Diagnosis of a primary brain and CNS cancer.
- •Patients with recurrent brain/CNS tumours eligible for further excision surgery will be included. This is because this group of patients are considered to have good performance score and similar in many characteristics to newly diagnosed patients with brain tumour.
- •No contraindication to undertaking moderate aerobic physical activity such as unstable angina, acute systemic illness or fever, uncontrolled diabetes, recent embolism (< 4 weeks), resting heart rate > 120 beats per minute, severe uncontrolled hypertension (180/110 mmHg), progressing worsening dyspnoea at rest or exertion over previous 3-5 days and severe anaemia (haemoglobin concentration ≤ 60 g/L).
- •Able to provide consent.
排除标准
- •Severe ataxia.
- •Co-morbidities such as severe cardiovascular or respiratory disease.
- •Acute or emergency neurosurgical intervention as primary treatment (the pre-operative exercise phase cannot be implemented).
- •Uncontrolled seizure disorder.
- •Patients primarily for palliation or on end of life care pathway.
- •Patients who require barrier nursing for infection control.
研究组 & 干预措施
Aerobic Exercise
Graduated supervised moderate intensity aerobic exercise
干预措施: Exercise (either aerobic or flexibility) (Behavioral)
Flexibility Exercise
Home based self-supervised flexibility exercises
干预措施: Exercise (either aerobic or flexibility) (Behavioral)
结局指标
主要结局
6 minute walk test.
时间窗: 4 weeks
Distance walked in metres by participants in 6 minutes on a level indoor surface before and after intervention.
Sit and reach test
时间窗: 4 weeks
Flexibility measurement in centimetres using a sit and reach box
Hand grip strength
时间窗: 4 weeks
Hand grip strength in Kg of study participants using portable dynamometry before and after intervention.
Vertical jump test
时间窗: 4 weeks
Vertical height jumped in centimetres using an electronic jump mat
Karnofsky Performance Status (KPS)
时间窗: 4 weeks
Measurement or performace on an ordinal rating scale
次要结局
- Serum Uric acid(4 weeks)
- Functional independence measure (FIM) and Functional assessment measure (FAM)(4 weeks)
- Interleukin-6 assay(4 weeks)
- Plasma viscosity (PV)(4 weeks)
- Insulin-like growth factor 1 (IGF1)(4 weeks)
- Insulkin-like Growth Factor Binding Protein -3 (IGFBP3)(4 weeks)
- Borg rate of perceived exercition(4 weeks)
- Health related quality of life (HRQOL) of participants before and after intervention: questionnaires(4 weeks)
- C-reactive protein level(4 weeks)
- Full Blood Count(4 weeks)
- Rehabilitation Complexity scale (RCS).(4 weeks)