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临床试验/NCT04114331
NCT04114331已完成不适用

Feasibility of a Post-Hospitalization PT Intervention in Patients With Pneumonia

The University of Texas Medical Branch, Galveston2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年2月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Posture, as measured by change in height

研究概览

简要总结

The original intent was to use a manual therapy and therapeutic exercise intervention with older patients with pneumonia post-hospitalization. It was hypothesized that the physical therapy intervention would have a positive impact on posture, physical function, pulmonary function, gait, quality of life, and ultimately readmission. This patient population was found to be not feasible to recruit and the study target population was expanded to include older community dwelling adults with pneumonia, chronic obstructive pulmonary disease (COPD), or hyperkyphosis.

详细描述

This original study was a feasibility study to determine the ability to recruit and to assess pilot data to determine the effects of a physical therapy intervention on physical function, gait, balance, posture, pulmonary function, and quality of life. Additionally the 30 day readmission, ER visits, and mortality was to be tracked. This study failed due to lack of recruitment. However, the aim to examine the effectiveness a physical therapy intervention was still used just in a broader population. The intervention and measures remained the same except for 30 day admission/mortality data.

The new aim was to examine the effectiveness of manual therapy and exercise on posture, function, gait, pulmonary function, and quality of life in older community dwelling adults with hyperkyphosis or forward head posture. Kyphosis, osteoporosis, decreased trunk flexibility, and pain are considered potential causes of restrictive lung function. The physical therapy intervention targets both soft tissue and skeletal restrictions to improve mobility. The outcomes were chosen to examine not only the direct impact on posture but also the indirect impact on physical function including pulmonary status. Lastly, cognitive mapping was used to record the change in the perceptions of the participants as they improved.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • at least 50 years of age
  • hyperkyphosis, forward head posture, pneumonia, or chronic obstructive pulmonary disease (COPD)
  • community dwelling
  • self report of ability to walk 10 feet or greater with or without an assistive device
  • ability to perform informed consent
  • ability to transport to research facility
  • ability to read and write in English or Spanish

排除标准

  • Inability to perform informed consent
  • Inability to follow directions
  • Inability to perform transfers, sit, and stand independently
  • Inability to ambulate 10 feet or more with or without an assistive device
  • Inability to perform pulmonary function testing
  • Inability to fully participate in testing and measures
  • Inability to fully participate in the intervention
  • Severe claustrophobia
  • Unable to tolerate physical touch
  • Morbid obesity (BMI greater than 40)
  • History of prior lung disease such as cancer or transplant
  • History of comorbidity that would affect lung function such as neuromuscular disease (ALS, MS), collagen disease (SLE), cardiovascular disease (CHF), or musculoskeletal disease with an autoimmune component (Ankylosing Spondylosis, RA).
  • A prior discharge within 30 days of hospitalization for pneumonia or COPD
  • Discharge against medical advice

结局指标

主要结局

Posture, as measured by change in height

时间窗: through study completion (4 weeks) and one time follow-up at an average of 6 months

Height in cm

Posture, as measured by change in kyphotic index

时间窗: through study completion (4 weeks) and one time follow-up at an average of 6 months

kyphotic index = (thoracic width/thoracic height) \*100 as measured from flexicurve tracing. A flexible ruler is molded to the posterior spine from C7 to the lumbosacral interspace. Ruler is placed on paper and traced. Measures of the thoracic width and height are taken in centimeters.

Posture, as measured by change in block test

时间窗: through study completion (4 weeks) and one time follow-up at an average of 6 months

height of blocks (measured in cm) under the head with participant supine

Posture, visual change in digital photos

时间窗: through study completion (4 weeks) and one time follow-up at an average of 6 months

Digital photo in standing anterior and side views as well as supine view

次要结局

  • Function as a change in Timed Up and Go speed(through study completion (4 weeks) and one time follow-up at an average of 6 months)
  • Function and Gait as a change in the 2 Minute Walk Test (2MWT)(through study completion (4 weeks) and one time follow-up at an average of 6 months)
  • Function as a change in Functional Reach test(through study completion (4 weeks) and one time follow-up at an average of 6 months)
  • Function and patient perception as change in the Patient Specific Functional Scale (PSFS)(through study completion (4 weeks) and one time follow-up at an average of 6 months)
  • Function as a change in the Short Physical Performance Battery (SPPB) score(through study completion (4 weeks) and one time follow-up at an average of 6 months)
  • Patient perception as measured by changes in Cognitive Mapping(through study completion (4 weeks) and one time follow-up at an average of 6 months)
  • Gait as measured by change in gait parameters on a Gaitrite walkway(through study completion (4 weeks) and one time follow-up at an average of 6 months)
  • Gait as measured by change in Tekscan measures of force(through study completion (4 weeks) and one time follow-up at an average of 6 months)
  • Pulmonary function change measure by spirometry(through study completion (4 weeks) and one time follow-up at an average of 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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