Individualized and Person-centred Physical Activity and Exercise for Patients With Non Functioning Pituitary Adenoma - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Changes in quality of life
研究概览
简要总结
The goal of this clinical trial is to learn about physical activity's effect on health in people who have had surgery of a non-functioning pituitary adenoma.
The main questions it aims to answer are:
- Do physical activity increase quality of life?
- Do physical activity increase general health, cardiovascular fitness, self-efficacy and muscle strength and reduce fatigue and cardiovascular risk profile?
Participants will at the start of the the study, at 6 months follow up and 12 months follow up:
- Fill out health surveys
- Perform a cycling test, hand strength test, chair stand test and wear and accelerometer for a week
- Undergo a dual energy X-ray absorptiometry to measure muscle and fat mass
- Leave blood samples
Researchers will compare those who are randomized to the intervention and see a physiotherapist to get an individualized and person-centred prescription of physical activity plan and those who are randomized not to be in the intervention to see if physical activity increases quality of life and general health.¨.
详细描述
This study is an unblinded, prospective, randomized, controlled trial where 120 participants will be assigned to either an intervention group or a control group - 60 in each arm. The intervention will receive an individualized and person-centred prescription of physical activity and exercise. The control group will get standard care.
Inclusion criteria
- Patients with non-functioning pituitary adenoma treated with surgery the last ten years
- Stable hormone replacement therapy ≥ 6 months
- Age 18-75 years
- Ability to communicate in Swedish.
Exclusion criteria
- Patients with other pituitary tumours than non-functioning pituitary adenoma
- Patients who could need tumour intervention (surgery or radiotherapy), within one year
- Co-morbidities that could have significant impact on the outcome variables
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinically significant non-functioning pituitary adenoma treated with surgery during the last ten years
- •Stable hormone replacement therapy ≥ 6 months
- •Ability to communicate in Swedish.
排除标准
- •Patients with any other pituitary tumors than non-functioning pituitary adenoma
- •Patients who possibly need tumor intervention, either with surgery or radiotherapy, within one year
- •Other diseases or co-morbidities that may have significant impact on the outcome variables, including:
- •Ongoing substance abuse and/or untreated psychiatric disorder, including psychoses and bipolar disease (except treatment with SSRI (Selective Serotonin Reuptake Inhibitor) and or SNRI (Serotonin-Norepinephrine Reuptake Inhibitor) for mild/moderate depression and/or anxiety which is allowed).
- •Medical therapy with opioids, sedatives or hypnotics (besides treatment with zopiclone and zolpidem which are allowed).
- •Current or previous history of neurological diseases with impaired mobility.
- •High alcohol consumption (more than 14 alcohol units per week)
- •Ongoing treatment for cancer.
- •Uncontrolled hypertension or presence of clinically significant cardiac disease
- •Severe respiratory insufficiency.
- •Severely impaired hepatic function (ALT (Alanine Aminotransferase) and/or AST (Aspartate Aminotransferase) concentrations two times above the upper limit of normal).
- •Severely impaired renal function (Glomerular filtration rate <45 ml/min).
- •Untreated hypo- or hyperthyroidism
- •Pregnancy or breast feeding.
研究组 & 干预措施
Control group
This group will receive standard care.
Intervention group
This group will receive an individualized and person-centred prescription of physical activity and exercise in addition to standard care.
干预措施: Physical activity (Other)
结局指标
主要结局
Changes in quality of life
时间窗: At 12 months follow up
Measured with the Short Form Survey Instrument (SF-36), where the score is transformed to a scale 0-100 where 100 represents be best possible health status and quality of life..
次要结局
- Changes in fitness/muscle strength - Hand strength(At 12 months follow up)
- Changes in cardiovascular risk profile - Blood samples(At 12 months follow up)
- Changes in fitness/muscle strength - Accelerometer(At 12 months follow up)
- Changes in fitness/muscle strength - Cycling(At 12 months follow up)
- Changes in fitness/muscle strength - Chair stand(At 12 months follow up)
- Changes in cardiovascular risk profile - Blood pressure(At 12 months follow up)
- Changes in health status(At 12 months follow up)
- Changes in self-reported self-efficacy(At 12 months follow up)