The Effects of 24 Weeks Community-based Brisk Walking on Physical Function, Comorbidities, Cognition, Disease Severity, and Health-related Quality of Life in People With Parkinson's Disease.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- The Generic Walking Scale - 12 items (Walk-12G)
研究概览
简要总结
The goal of this clinical trial is to investigate if brisk walking can improve walking function in people with Parkinson's disease and what kind of brisk walking intervention that is most effective. The main questions are:
If brisk walking can reduce self-perceived walking difficulty What type of exercise intervention is most effective. Researchers will compare a brisk walking group receiving a personalized walking program with a group receiving an activity tracker and a control group.
Participants will
- be tested at baseline (0 weeks), post the intervention period (24 weeks) and after a follow-up period (48 weeks).
- be randomly allocated to one of three groups at baseline.
- follow the prescribed intervention they are allocated to.
详细描述
Background Parkinson's disease is a progressive neurodegenerative disorder and one of the leading causes of disability worldwide. Impaired walking is considered one of the most bothersome symptoms that people with Parkinson's disease wish to improve, affecting independence, ability to work, and quality of life. Walking impairment is present from the early stage of the disease with an expected progression and a more frequent presentation along the course of the disease. Currently, only few medical treatments exist that target walking, and these show minor effects while causing side effects. Non-pharmacological interventions that can improve or prevent loss of walking ability are therefore highly warranted.
Exercise is a promising non-pharmacological intervention in people with Parkinson's disease with studies reporting improved walking performance following different exercise modalities, including high-intensity aerobic exercise. Despite extensive research investigating the effects of various exercise interventions on walking, few have examined more traditional walking training. This is somewhat surprising as walking is task-specific training for walking itself, while also being feasible and showing promising results in people with Parkinson's disease. In addition, walking is easily accessible and a potential efficient low-cost intervention that is commonly used and therefore well-known in clinical rehabilitation practice. Yet only two long-term studies could be located applying walking training. Despite being long-term, these studies are limited by 1) not considering possible factors facilitating adherence, 2) not performing follow-up testing, 3) not applying any inclusion criterion for walking impairment implying that any potential effects might be diminished due to well-functioning participants without walking impairments, 4) not including a comprehensive test battery (i.e., no registration of comorbidities, physical activity level, health-related quality of life), and 5) not investigating the effect on perceived walking difficulties despite the relevance of understanding the subjective impact of walking training. Further evaluation of walking interventions is therefore needed in people with Parkinson's disease.
Despite the importance of a physically active lifestyle, only 27% (potentially less) of people with Parkinson's disease meet the established physical activity recommendations (≥ 150 min/week of moderate to vigorous physical activity). Therefore, it is very challenging to design a walking intervention that increases physical activity levels while being sustainable. To do so, it is essential to incorporate motivational factors that facilitate adherence. These include high self-efficacy, low cost, less travel, self-perceived positive effects of walking, and support from family/carers and health professionals. To comply with these factors, remotely or partly supervised home-based exercise has been suggested as a feasible and effective strategy to alleviate Parkinson's disease motor symptoms. Another aspect to consider is group vs. individually based exercise sessions. Both have shown equally effective in improving functional capacity in healthy individuals, but combined group- and individual-based exercise has been recommended as the most attractive model for the broadest range of people with Parkinson's disease. Overall, by incorporating these strategies in walking training, this exercise modality might offer a sustainable, cost-effective, and easy-to-apply intervention that can be offered in local communities worldwide. This would also include people with Parkinson's disease living without easy access to training facilities or who are governed by poor healthcare systems. Another even more easy-to-apply and low-cost intervention to increase physical activity, is to offer a wearable activity tracker. One study reported increased physical activity level in people with Multiple sclerosis when offering a wearable activity tracker and engaging in group- and individual motivational online meetings compared to a control group. However, to the investigator's knowledge, this has not been assessed in people with Parkinson's disease.
Therefore, the primary aim is to investigate the efficacy of a 24-week combined supervised group- and non-supervised individual-based walking intervention (WALK) compared to both a group receiving a wearable activity tracker (HOME) and a control group (CON) on perceived walking difficulties in people with Parkinson's disease. The secondary aims are to identify and characterize responders and non-responders to walking training and to investigate the cost-effectiveness of these exercise interventions.
The hypothesis is that the WALK group will be superior to HOME and CON, while HOME will be superior to CON after 24 weeks in reducing perceived walking difficulties, which will be sustained after a 24-week follow up.
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
- 40 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically diagnosed with Parkinson's disease
- •aged ≥40 years
- •Hoehn and Yahr stage ≤3
- •able to independently undertake transportation back and forth from test days and training sessions
- •expectedly able to complete ≥85% of the training sessions
- •experience walking difficulties (the generic walking scale (Walk-12G) score ≥8.5).
排除标准
- •have another neurological disorder or other disorders that affect gait and balance (e.g., severe arthritis or arthrosis)
- •are pregnant
- •have dementia (Montreal Cognitive Assessment score <18)
- •are suffering from alcohol abuse (i.e., exceeding ten units per week, according to the Danish Health Authority recommendation
- •have cardiovascular, respiratory, orthopedic, or metabolic disorders or other medical comorbidities hindering participation in maximal exercise testing.
- •have a depression
- •use an activity tracker during exercise
- •performing high-intensity brisk walking three or more times during a week.
结局指标
主要结局
The Generic Walking Scale - 12 items (Walk-12G)
时间窗: From enrollment to the end of follow-up at 48 weeks
The generic walking scale is a 12-item questionnaire covering different aspects of walking difficulties during everyday life. Scores ranged from 0 (no problem) to 42 (severe walking difficulties)
次要结局
- Six-minute walk test (6MWT)(From enrollment to the end of follow-up at 48 weeks)
- Demographic measures(From enrollment to the end of follow-up at 48 weeks)
- Chair rise(From enrollment to the end of follow-up at 48 weeks)
- Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating scale (MDS-UPDRS) part I, II, III, and IV(From enrollment to the end of follow-up at 48 weeks)
- Mini Balance Evaluation Systems Test (MiniBESTest)(From enrollment to the end of follow-up at 48 weeks)
- Timed-up and Go (TUG)(From enrollment to the end of follow-up at 48 weeks)
- Six-Spot Step Test (SSST)(From enrollment to the end of follow-up at 48 weeks)
- The Montreal Cognitive Assessment (MoCA) test(From enrollment to the end of follow-up at 48 weeks)
- Symbol Digit Modalities Test (SDMT)(From enrollment to the end of follow-up at 48 weeks)
- Maximal oxygen consumption test (VO2max test)(From enrollment to the end of follow-up at 48 weeks)
- Borg scale (part of VO2max test)(From enrollment to the end of follow-up at 48 weeks)
- Maximal heart rate (part of VO2max test)(From enrollment to the end of follow-up at 48 weeks)
- Physcial activity level(From enrollment to the end of follow-up at 48 weeks)
- Physical Activity Enjoyment Scale (PACES) (questionnaire)(Only at the post test (24 weeks))
- Baecke Physical Activity Questionnaire (BHPAQ) (questionnaire)(From enrollment to the end of follow-up at 48 weeks)
- EuroQol-5 Domain-5 level (EQ-5D-5L) (questionnaire)(From enrollment to the end of follow-up at 48 weeks)
- Modfied Fatigue Impact Scale (MFIS) (questionnaire)(Baseline only)
- Major Depression Inventory (MDI) (questionnaire)(From enrollment to the end of follow-up at 48 weeks)
- Non-Motor Symptoms Questionnaire (NMSQuest) (questionnaire)(From enrollment to the end of follow-up at 48 weeks)
- Parkinsons Disease Questionnaire-39 items (PDQ-39) (questionnaire)(From enrollment to the end of follow-up at 48 weeks)
- Parkinsons disease Fatigue Scale-16 items (PFS-16) (questionnaire)(From enrollment to the end of follow-up at 48 weeks)
- The Pittsburgh Sleep Quality Index (PSQI) (questionnaire)(From enrollment to the end of follow-up at 48 weeks)
- Breif Pain Inventory (BPI) (questionnaire)(From enrollment to the end of follow-up at 48 weeks)
- Falls Efficacy Scale - International (FES-I) (questionnaire)(From enrollment to the end of follow-up at 48 weeks)
