The Assessment of the Feasibility of a Home Based Post-operative Exercise Training Programme Targeting Physical and Cognitive Function in Older Patients Undergoing Major Body Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Feasibility of a home based exercise programme following surgery in the older patient.
研究概览
简要总结
The primary aim of this study is to establish if it is possible for patients who have undergone major body surgery to complete a home based exercise training program and complete the assessments required to measure physical and cognitive function. If the investigators can establish that it is feasible to complete the training and test's then further research can follow using these methods to determine whether it is possible to improve the physical function of older patients undergoing major abdominal surgery in the period following surgery by using a simple exercise regimen that can be carried out at home. By targeting physical function in this way the investigators hope to determine if it is a method for improving frailty and well being. In turn it may also have a positive impact on health service provision.
详细描述
Frailty is a geriatric syndrome describing a lack of physiological reserve. It is an independent risk factor for morbidity, mortality and increased length of hospital stay. Five criteria can be used to describe Frailty: weight loss, exhaustion, diminished hand-grip strength, slow walking speed, and low physical activity. Sarcopenia, the loss of skeletal muscle mass and strength, is a key component of all of these criteria and of Frailty itself.
By assessing Frailty, vulnerable patients can be recognised early so that additional measures can be implemented. Interventions to ameliorate the severity of an individual's Frailty are currently the focus of much attention as these can positively impact on the patients physical and cognitive function and well-being. In turn this has a positive impact on health service provision reducing hospital length of stay, morbidity and mortality.
The exercise programme used in this study incorporates the High-Intensity Functional Exercise (HIFE) programme for older individuals developed by Umea University Sweden with exercises incorporated from the Help the Aged Preventing Falls Programme. The exercises are designed such that they can be performed at home with no additional aids. The participants will be required to begin the programme on discharge from hospital and undertake exercises three times per week. They will receive instruction, help and support prior to discharge and throughout the 6 month exercise period. The participants will be required to complete an exercise diary to monitor their compliance with the programme and to determine the feasibility of a home based exercise programme as an intervention measure.
The outcome measures of physical function will be assessed by the Handgrip strength and Step Box testing plus questionnaires assessing daily activities, Sarcopenia will be assessed using the Handgrip test to measure muscle strength and quantification of muscle mass through muscle ultrasound (USS) imaging. Cognitive function will be assessed by the use of validated questionnaire and online cognitive tests. Frailty by the Reported Edmonton Frail Scale.
Experimental design and methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing major body cavity surgery.
- •Male and Female patients.
- •Age greater than 70 years.
- •Patients undergoing neo-adjuvant chemotherapy will be included.
排除标准
- •Participation in a formal exercise regime
- •A BMI > 35 kg·m2
- •Active cardiovascular disease: uncontrolled hypertension (BP > 180/100), angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt, recent cardiac event
- •Taking beta-adrenergic blocking agents.
- •Cerebrovascular disease: untreated aneurysm (large vessel or intracranial).
- •Respiratory disease including: pulmonary hypertension.
- •Metabolic disease: hyper and hypo parathyroidism, untreated hyper and hypothyroidism, Cushing's disease.
- •Musculoskeletal or neurological disorders
- •Family history of early (<55y) death from cardiovascular disease
- •Severe rheumatoid arthritis limiting ability to perform any part of the assessment process.
- •Unable to complete the consent process.
研究组 & 干预措施
Control
Participants will receive standard NHS care with no intervention.
Exercise
Participants will receive standard NHS care and complete the exercise programme, the intervention.
干预措施: Exercise Programme (Other)
结局指标
主要结局
Feasibility of a home based exercise programme following surgery in the older patient.
时间窗: 3 and 6 months
To determine the feasibility of a post-operative home based exercise program at 3 and 6 months, for older patients over 70 years of age, who have undergone major body cavity surgery. To assess if this approach is an acceptable and practically viable health intervention in this demographic group. The feasibility will be assessed through the use of interviews with the participants, review of the participants exercise diary and written participant feedback.
次要结局
- Step Box Test(3 and 6 months)
- Muscle Architecture Ultrasound(3 and 6 months)
- Cognitive testing(3 months)
- Frailty(3 and 6 months)
- Subjective Outcome measure: Physical Activity.(3 and 6 months)
- Subjective Outcome measure: VO2max measure(3 and 6 months)
- Subjective Outcome measure: Physical Activity(3 and 6 months)
- Subjective Outcome measure: Quality of Life(3 and 6 months)
- Hand Strength Test(3 and 6 months)