Effectiveness of a Home-Based Exercise Program Supported by Self-Management Education in People With Parkinson Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Berg Balance Scale Score
研究概览
简要总结
This randomized, assessor-blinded clinical trial evaluates whether a structured self-management education and home exercise program improves balance, walking capacity, fall-related concerns, upper-extremity dexterity, and quality of life in adults with Parkinson disease. Fifty-five participants aged 45-80 years will be randomized to an intervention or control arm. Outcomes will be assessed at baseline, after the 8-week intervention, and at Week 16. The primary outcome is the Berg Balance Scale.
详细描述
Participants meeting the eligibility criteria at Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation will be assigned by a computer-generated randomization procedure to two parallel groups. The intervention group will receive a clinician-led self-management education session, supervised instruction in a home exercise program, an exercise video, an exercise log, and weekly telephone support to monitor and encourage adherence. The home exercise program will include posture, relaxation and deep-breathing exercises; active range-of-motion and stretching exercises for the upper and lower extremities; hip and knee strengthening; rhythmic gait training; and balance, coordination, and proprioception exercises. Participants will be instructed to perform the program three days per week for 30-45 minutes per session for eight weeks. The control group will receive a booklet containing general information about Parkinson disease and will continue to receive usual clinical care. The control group will not receive the structured self-management session, supervised exercise instruction, exercise video, prescribed home exercise program, or weekly adherence-support telephone calls during the study period. An assessor blinded to group allocation will perform outcome assessments at baseline, Week 8, and Week 16.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessments are performed by a researcher who is blinded to group allocation. Participants and personnel delivering the behavioral intervention cannot be blinded.
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Parkinson disease
- •Age 45 to 80 years
- •Parkinson disease diagnosed at least 1 year before enrollment
- •Clinically stable, with no change in medication dose or treatment plan during the previous 3 months
- •Modified Hoehn and Yahr stage 1 to 3
排除标准
- •Cardiovascular, pulmonary, or systemic disease that may limit exercise participation
- •Cognitive impairment or a communication barrier that prevents study participation
- •Participation in a regular rehabilitation program during the previous 3 months
研究组 & 干预措施
Self-Management Education and Home Exercise
Participants receive a clinician-led self-management education session; practical exercise instruction with a physiotherapist; an exercise video and educational booklet; an exercise log; and weekly telephone adherence support. The home exercise program is performed 3 days per week for 30-45 minutes per session for 8 weeks.
干预措施: Self-Management Education and Home Exercise Program (Other)
Control Group
In addition to standard medical treatment, participants in the control group received an educational booklet containing general information about Parkinson disease and exercise recommendations. They did not receive a structured exercise program or any additional follow-up during the study.
干预措施: Parkinson Disease Educational Booklet (Behavioral)
结局指标
主要结局
Berg Balance Scale Score
时间窗: Baseline, Week 8, and Week 16
The Berg Balance Scale is a short, safe, and simple balance test that measures an individual's ability to maintain balance while performing functional tasks. The scale consists of 14 items. Performance on each activity is rated using a five-point scale ranging from 0, "unable to perform," to 4, "able to perform independently and safely." The items assess activities in which maintaining position becomes progressively more difficult and the base of support is reduced. They include daily functional tasks such as standing unsupported, sitting unsupported, moving from standing to sitting, performing transfers, standing in tandem, and standing on one leg. The maximum total score is 56, with higher scores indicating better balance
次要结局
- Falls Efficacy Scale-International Score(Baseline, Week 8, and Week 16)
- Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(Baseline, Week 8, and Week 16)
- Timed Up and Go Test(Baseline, Week 8, and Week 16)
- 6-Minute Walk Test Distance(Baseline, Week 8, and Week 16)
- Parkinson's Disease Questionnaire-39 Score(Baseline, Week 8, and Week 16)
- Box and Block Test(Baseline, Week 8, and Week 16)
- Home Exercise Adherence(Week 8)
- Modified Hoehn and Yahr Staging(baseline, week 8, week 16)