Effect of Mobile Health Technology (mHealth), Exercise Adherence and Optimal Nutrition Post Rehabilitation Among People With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Six minute walk test (6MWT)
研究概览
简要总结
A randomized, controlled trial to evaluate the effect of six months digital follow-up, after a stay at a rehabilitation center, on functional and nutritional status in people with Parkinson Disease.
详细描述
It is found that regular, structured exercise is especially important for people with Pakinson disease (PD) and it is a key element in the treatment of PD at rehabilitation centers in Norway. A substantial amount of research indicate that exercise can lead to improvements in physical functioning, strength, balance, gait, and HRQOL among people with PD. However, after a supervised exercise period, these measures tend to return toward baseline values. This regression may to some extent reflect the progressive nature of PD, but previous research suggests that maintaining the motivation to stay physically active is difficult once formalized interventions end. Furthermore, research indicate that nutritional status is an important predictor for health status among people with PD and that PD patients have high rates of unintentional weight loss compared to age-matched controls. In other words, research indicate that follow-up at home after rehabilitation is necessary to increase optimal nutrition and continuing to exercise.
This is a randomized controlled trial meant to evaluate the effect of six months digital follow-up, after a 3-5 week stay at a inpatient rehabilitation center, on functional and nutritional status in people with PD.
Eligible participants will be recruited from Unicare Fram Rehabilitation center by a physical therapist and research assistant in collaboration with Unicare Fram employees and a Ph.D student. Informed consent from the participants is obtained from persons with no previous relationship to the patients, and who are not included in their daily treatment, mainly the research assistant. After baseline testing the participants will be randomly allocated to an intervention- or control group.
The intervention in this study is designed to increase the level of adherence after rehabilitation by implementing factors that previous studies have proven successful such as education, goal setting, follow-up from health care personnel and use of mHealth Technology. The intervention consist of 2 phases.
Phase 1: All participants will receive the rehabilitation program currently provided at Unicare Fram rehabilitation center. This is a comprehensive and interdisciplinary rehabilitation program with focus on self-management of the disease including exercise and nutrition.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The complex intervention makes masking of participants and care provider impossible. An independent therapist will conduct baseline testing before randomization. The same therapist will conduct the re-testing at 12 weeks and six month, the assessor will be blinded to group allocation and not be part off providing the intervention. The person conducting the data-analyzes will be blinded to group allocation.
A computer-generated, permuted block randomization scheme will be used to allocate patients.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>40 years
- •Living at home
- •Living max 2,5 hours travel distance from Unicare Fram
- •A diagnosis of idipathic PD
- •Hoehn-Yahr stage 1-3
- •eternal feeding ability
- •must own a smart phone
排除标准
- •Hoehn-Yahr stage 4-5
- •Medical issues that might affect participation in exercise programs
- •Diagnosis of dementia
- •Diagnosis of severe dysphagia
- •Exercises regularly more than twice a week(structured exercise).
结局指标
主要结局
Six minute walk test (6MWT)
时间窗: measured at baseline, 12 weeks and 6 months
A sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. It evaluates the functional capacity of the individual.
次要结局
- The Patients-Generated subjective Global Assessment Short Form (PG-SGA)(measured at baseline, 12 weeks and 6 months)
- and 5x sit-to-stand(measured at baseline, 12 weeks and 6 months)
- The Parkinson's disease questionnaire (PDQ-39)(measured at baseline, 12 weeks and 6 months)
- Radboud Oral Motor Inventory for Parkinson's disease (ROMP) - swallowing(measured at baseline, 12 weeks and 6 months)
- mini best test(measured at baseline, 12 weeks and 6 months)
- Bioelectrical impedance analysis(measured at baseline, 12 weeks and 6 months)
- What do you eat(measured at baseline)