Randomised Controlled Trial of Exercise Intervention as an Adjunct to Medical Therapy in Newly Diagnosed Patients With Pulmonary Arterial Hypertension
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Six-minute walk distance
概览
简要总结
The goal of this clinical trial is to learn if an exercise programme started shortly after diagnosis improves the fitness and mental wellbeing of patients with pulmonary hypertenion over and above medication alone. It will also learn about whether extra support can help patients keep up with exercise in the long term. The main questions it aims to answer are:
- Doe exercise improve how far patients can walk over six minutes
- Does exercise improve quality of life scores
- Does exercise improve mental health scores
- Does extra support after an exercise programme help patients to continue exercising in the long term
Researchers will compare the exercise programme to a control group (a group of similar patients who do not receive the exercise programme) to see the effect that exercise has.
Participants in the exercise programme group will:
- Undergo an exercise programme for 12 weeks, starting around 3 months after their diagnosis
- They will undertake the exercise programme at home, remotely supervised by the research team with regular contact
- Visit the clinic at the end of the programme for checkups and tests
- Keep a diary of their exercise and how they are feeling
Participants in the control group will:
-Still undergo the exercise programme, but this will happen at a delayed time, starting around 6 months after diagnosis, to allow for a comparison between the two groups.
Following completion of the exerise programme:
- Half of participants will receive extra support to help them continue to exercise
- The other half will not receive any additional support
- All patients will be reviewed 1 year following the completion of their exercise programme to monitor their ongoing exercise levels.
详细描述
This study is designed to deliver a remotely supervised, home-based exercise programme to patients newly diagnosed with pulmonary arterial hypertension with a view to early optimisation of their condition. The design is a waitlist randomised controlled trial whereby participants will be randomised to an exercise intervention or control group, with the control group then going on to have access to the exercise programme after a 12-week delay. There will be further randomisation after completion of the exercise programme to determine if participants have access to support package aimed at improving adherence to exercise.
The study objectives are to evaluate:
- The incremental effect of an exercise programme on exercise capacity, quality of life and mental health
- The impact of an additional support package following completion of the exercise programme on adherence to exercise in the long term.
Methodology Patients will be recruited from the Scottish Pulmonary Vascular Unit and consented for the study at the time of diagnosis with pulmonary arterial hypertension.
Participants will be commenced on pulmonary vasodilator therapy as per standard of care decided by the clinical team, then will be reviewed 3 months later at outpatient clinic.
Half of participants will then be randomly assigned to an intervention group and the remaining half to a control group. The intervention group will start a 12-week home-based remotely supervised exercise programme while the control group continue on medical therapy alone to allow for comparison. After this 12 weeks, participants in both groups will be seen back in clinic for further review and data collection. The control group will then commence the exercise programme.
After each participant completes the exercise programme they will then be randomly assigned to either receive a support package from the research team, designed to improve adherence to exercise, or to act as a control group and continue with self-directed exercise. All participants will be reviewed one year after completing the exercise programme to review their adherence to exercise.
Data collection:
Data will be collected at standard of care outpatient clinic appointments (six-minute walk test results, EmPHasis-10 questionnaires, NT-proBNP test. Study questionnaires will also be checked at these visits (PHQ-9 and GAD-7 questionnaires at all visits, exercise adherence rating scale questionnaire at the final visits).
Smartwatches will also be worn by study participants and data will be collected on step count, exercise frequency and intensity, heart rate variability, sleep.
Qualitative data will be gathered from the participants by interview at the end of the exercise programme and following their follow-up phase to evaluate factors that helped or hindered exercise.
Exercise programme:
The exercise programme is carried out fully remotely and has been adopted from the PHAHB study by McCormack et al 2019 and includes induction training sessions (discussing the introduction to exercise equipment, the provided materials, exercise safety and demonstrations) and health coaching sessions (discussing various topics including benefits of exercise, goal setting, action planning, self-monitoring, identification and management of barriers to exercise, problem solving and feedback on behaviour).
There are three types of training activities in the programme which are aerobic training (either walking, cycling or a combination), resistance training (using body weight exercises, but may progress to using resistance bands or light weights) and respiratory training. These activities are built up gradually throughout the programme on an individualised basis over a 12-week period.
Exercise support package:
The exercise adherence package will consist of access to online exercise resources, monthly phone calls from the research team and a forum to allow participant discussion and encouragement.
Sample size: Recruitment target is 40 patients with a 1:1 randomisation to the intervention and control groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Aged 18-years-old and above
- •Diagnosed with pulmonary hypertension (group I and non-operable group IV) by right heart catheterisation showing:
- •a baseline mean pulmonary artery pressure \>20mmHg
- •pulmonary vascular resistance \>2 Wood Units
- •pulmonary capillary wedge pressure \<15mmHg
- •Able to provide written informed consent
排除标准
- •Diagnosis with pulmonary hypertension of any other cause
- •Group II (PH due to left heart disease)
- •Group III (PH due to hypoxic lung disease)
- •Operable group IV (PH due to chronic thromboembolic disease amenable to surgical treatment)
- •Group V (unclear and/or multifactorial elements).
- •Planned treatment with a research trial medication during the study timeframe
- •Consenting clinician and/or patient concern regarding the patient's safety in performing a home-based exercise programme
- •Patients with syncopal episodes felt to be related to pulmonary hypertension at time of exercise intervention initiation.
- •Severe concurrent medical condition that would prevent participation in study procedures
- •Life expectancy \<3 months
研究组 & 干预措施
Exercise Intervention Group then Adherence package group during follow-up phase
Initially randomised to the exercise intervention group. Following completion of the exercise intervention, then randomised to receive the adherence support package.
干预措施: Home-based, remotely delivered, supervised Exercise programme (Other)
Exercise Intervention Group then control group during follow-up phase
Initially randomised to the exercise intervention group. Following completion of the exercise intervention, then randomised to the control group during the follow-up phase, so not given the adherence support package.
干预措施: Home-based, remotely delivered, supervised Exercise programme (Other)
Control group, then the Adherence package group during the follow-up phase
Initially randomised to the control group. Then randomised to receive the adherence support package in the follow-up phase
Control group, then also randomised to the control group in the follow-up phase
Initially randomised to the control group. Following completion of the exercise intervention, then randomised to be in the control group in follow-up phase, so not given the adherence support package.
结局指标
主要结局
Six-minute walk distance
时间窗: Around 6 months post diagnosis. (After completion of the exercise programme for those in the intervention group, and on medical therapy alone for those in the control group).
Distance walked as measured during a six-minute walk test. Measured at around 6 months post-diagnosis to compare those from the exercise intervention group who have just completed their exercise programme, with the control group who have not yet had their exercise programme.
次要结局
- EmPHasis-10 questionnaire(Around 6 months post diagnosis. (After completion of the exercise programme for those in the intervention group, and on medical therapy alone for those in the control group).)
- NT-proBNP blood test(Around 6 months post diagnosis. (After completion of the exercise programme for those in the intervention group, and on medical therapy alone for those in the control group).)
- Patient Health Questionnaire-9(Around 6 months post diagnosis. (After completion of the exercise programme for those in the intervention group, and on medical therapy alone for those in the control group).)
- Generalised Anxiety Disorder 7-item Scale(Around 6 months post diagnosis. (After completion of the exercise programme for those in the intervention group, and on medical therapy alone for those in the control group).)