Including Manual Therapy in Pulmonary Rehabilitation Programs for US Veterans With Moderate Chronic Obstructive Pulmonary Disease: A Feasibility Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Spirometry
研究概览
简要总结
The aim of this study is to investigate the feasibility of administering this combination of interventions (CMT plus PR) to Veterans with moderate COPD within the context of a hospital-based outpatient pulmonary rehabilitation program.
详细描述
In 2016, the US Congress directed the Department of Defense to initiate a program to improve the health and well-being of all military Veterans, challenging the research and scientific communities to find original ideas that "foster new directions in research and clinical care". One of the areas identified as a priority under this initiative was 'Respiratory Health'.
Chronic obstructive pulmonary disease (COPD) is a major cause of disability, hospital admission and premature death. Current management strategies have not been successful in altering the loss of lung function typically seen as the disease progresses. Results from recent pilot trials suggest the novel combination of chiropractic manual therapy (CMT) and pulmonary rehabilitation (PR) has the potential to alter the typical pattern of decline in lung function.
The aim of this study is to investigate the feasibility of administering this combination of interventions (CMT plus PR) to Veterans with moderate COPD within the context of a hospital-based outpatient pulmonary rehabilitation program.
Twenty Veterans between the ages of 50 and 70 years with moderate COPD, will be randomly allocated to two equal groups. Group 1: 'sham' manual therapy plus pulmonary rehabilitation program; Group 2: Chiropractic manual therapy group plus the same pulmonary rehabilitation program (CMT+PR). Participants in both groups will undergo 8 treatment sessions over a 4 week period plus an additional assessment session at week 8. All sham manual therapy and CMT will be delivered just prior to pulmonary rehabilitation.
The primary purpose of the study is to assess the feasibility of conducting a larger randomized controlled trial by assessing the ability to recruit, enroll, deliver interventions and collect outcome measures on Veterans with moderate COPD. Secondary outcomes include lung function (Forced expiratory volume in the 1st second: FEV1 and Forced vital capacity: FVC), exercise capacity (six-minute walking test: 6MWT), quality of life (St Georges Respiratory Questionnaire: SGRQ), anxiety and depression levels (Hospital Anxiety and Depression scale: HAD) and frequency of exacerbations. All outcome measurements will be taken by blinded assessors.
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
Assessor will evaluate a de-identified database with the interventions labeled as 1 and 2.
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sex: Male and Female
- •Age range: 50-70 years
- •Disease status: Moderate COPD (FEV1% predicted: moderate 50-80% (GOLD 2018))
- •Concomitant disease status: Stable COPD (no exacerbations in preceding 6 months) Non-smoking (for preceding 6 months)
- •Willingness to give written informed consent.
- •Willingness to participate in and comply with the study requirements.
排除标准
- •Inability to complete 6-minute walking test unassisted
- •Contra-indicated to thoracic spinal manipulation
- •Thoracic joint instability
- •Acute pain on thoracic joint range of motion testing
- •High level of anxiety related to receiving thoracic spinal manipulation
- •Inability to understand English
- •People with a cognitive impairment, an intellectual disability or a mental illness
- •Completed a pulmonary rehabilitation program in the previous 12 months
结局指标
主要结局
Spirometry
时间窗: Change from Baseline to Post Intervention (4 weeks post baseline)
Lung function (Forced expiratory volume in the 1st second: FEV1 and forced vital capacity: FVC) will be assessed using spirometry.
次要结局
- Hospital Anxiety and Depression scale: HAD(Change from baseline to post intervention (4 weeks post baseline))
- 6 Minute Walking Test (6MWT)(Change from baseline to post intervention (4 weeks post baseline))
- St Georges Respiratory Questionnaire: SGRQ(Change from baseline to post intervention (4 weeks post baseline))
研究者
Paul Dougherty, DC
Staff Chiropractor
Canandaigua VA Medical Center