"SwallowFit," an Exercise Program and Randomized Clinical Trial Designed for US Service Members, Veterans, and Families Affected by Parkinson's Disease.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to learn if a proactive swallow exercise will help to improve swallow fitness in patients with Parkinson's disease.
The aim of the study is to assess how effective this exercise is and to measure the change in swallowing fitness from the beginning to the end of the study.
Patients who are given the exercise training will be compared to participants who are treated using the usual standard treatment.
Patients will have 6 weeks of twice-weekly SwallowFIT training. Each session will be an hour long.
详细描述
SwallowFIT: Subjects will receive 6-weeks of twice weekly SwallowFIT intervention per protocol (1-hour session each visit) from the BAMC speech language Pathologist (study SLP) at BAMC. Completion of the program will include 12 visits. The program is designed from a previous successful pilot trial. It begins with provision of general education on swallowing and swallowing change from the Parkinson's Foundation and Michael J Fox association websites.
Following this the program trains a modified effortful swallow technique at its onset using sEMG to guide the development of better swallow movement form, effort and performance. Once swallowing form is established, the program uses a hierarchy of swallowing tasks involving swallowing food/fluid materials at different complexity levels (swallow specificity) to stimulate and train progressive resistance and leverage variability of coordinated speeded actions.
Clinical Monitoring Only (CMO): This intervention mirrors the experimental intervention in all aspects, but the treatment type applied. CMO intervention reflects current swallow management practice for PD, where physicians monitor clinical function in swallowing and other related symptomology, referring for swallowing treatment only once an obvious issue has been identified.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Study investigators (PI, Co-I's, and Biostatistician), study coordinator and the Independent Evaluator, will be blind to the treatment allocation of the subjects. The PI will evaluate de-identified videoed assessments, and swallowing videofluoroscopic data.
入排标准
- 年龄范围
- 35 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult S-VWP between >35-90 years of age
- •Diagnosis of Idiopathic Parkinson's Disease [IDP] (either or suspected, tremor-predominant or rigid predominant)
- •Disability level of Hoehn & Yahr stages II-III as indicated in their most recent neurological evaluation
- •Swallowing concern, confirmed by Modified Unified Parkinson Disease Rating Scale [MDS-UPDRS]-
- •ADL swallowing item >0, or Mann Assessment of Swallowing scale [MASA] score ≤
- •Able to consume oral nutrition [Functional Oral Intake Score ≤ 6]
- •No change of medication for at least 4 weeks before study inclusion
排除标准
- •Classified as Hoehn and Yahr stages IV
- •Unable to follow 2 step commands
- •History of other neurological disease potentially causing dysphagia
- •Dementia (MMSE<20; Montreal cognitive assessment (MoCA) ≤ 20)
- •Severe depression (BDI>19)
- •Severe dyskinesia of head and neck (resulting in problems with MBSS recording)
- •Severe documented Gastrointestinal disease
- •History of Gastro-esophageal surgery
- •History of Head or neck cancer with swallowing impairment or surgical intervention
- •History of breathing disorders or diseases (e.g., Asthma, chronic obstructive pulmonary disease (COPD) requiring assistive breathing support.
- •Untreated hypertension
- •Heart disease requiring restricted activity and medical intervention
- •Speech therapy intervention for swallowing within the past three months
- •Women who are pregnant, nursing, or who plan to become pregnant during the study
研究组 & 干预措施
SwallowFit Intervention
Subjects randomized to intervention will receive 6-weeks of twice weekly SwallowFIT per protocol (1-hour session each day). The program begins with provision of general education on swallowing and swallowing change from the Parkinson's Foundation and Michael J Fox association websites. Following this the program trains a modified effortful swallow technique at its onset using surface electromyographic (sEMG) biofeedback to guide the development of better swallow movement form, effort and performance. From there it applies a hierarchy of swallowing exercises/tasks involving swallowing food/fluid materials at different complexity levels (swallow specificity) to stimulate and train progressive resistance and leverage variability of coordinated speeded actions.
干预措施: SwallowFit (Behavioral)
Clinical Monitoring Only (CMO)
CMO intervention reflects current swallow management practice for PD, where physicians monitor clinical function in swallowing and other related symptomology, referring for swallowing treatment only if an obvious issue has been identified. Subjects randomized to CMO will also receive general education on swallowing and swallow changes from the Parkinson's Foundation and Michael J Fox association websites.
研究者
Giselle Carnaby
Professor
The University of Texas Health Science Center at San Antonio