Clinical trial NCT04114331: Feasibility of a Physical Therapy Intervention on Older Adults With Hyperkyphosis or Forward Head Posture
Official title: Feasibility of a Post-Hospitalization PT Intervention in Patients With Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia
COPD
Hyperkyphosis
Postural, Thoracic Kyphosis
Keywords: forward head posture
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Posture, as measured by change in height
timeFrame: through study completion (4 weeks) and one time follow-up at an average of 6 months
measure: Posture, as measured by change in kyphotic index
timeFrame: through study completion (4 weeks) and one time follow-up at an average of 6 months
measure: Posture, as measured by change in block test
timeFrame: through study completion (4 weeks) and one time follow-up at an average of 6 months
measure: Posture, visual change in digital photos
timeFrame: through study completion (4 weeks) and one time follow-up at an average of 6 months
Secondary outcomes:
measure: Function as a change in Timed Up and Go speed
timeFrame: through study completion (4 weeks) and one time follow-up at an average of 6 months
measure: Function as a change in Functional Reach test
timeFrame: through study completion (4 weeks) and one time follow-up at an average of 6 months
measure: Function as a change in the Short Physical Performance Battery (SPPB) score
timeFrame: through study completion (4 weeks) and one time follow-up at an average of 6 months
measure: Function and Gait as a change in the 2 Minute Walk Test (2MWT)
timeFrame: through study completion (4 weeks) and one time follow-up at an average of 6 months
measure: Function and patient perception as change in the Patient Specific Functional Scale (PSFS)
timeFrame: through study completion (4 weeks) and one time follow-up at an average of 6 months
measure: Gait as measured by change in gait parameters on a Gaitrite walkway
timeFrame: through study completion (4 weeks) and one time follow-up at an average of 6 months
measure: Gait as measured by change in Tekscan measures of force
timeFrame: through study completion (4 weeks) and one time follow-up at an average of 6 months
measure: Pulmonary function change measure by spirometry
timeFrame: through study completion (4 weeks) and one time follow-up at an average of 6 months
measure: Patient perception as measured by changes in Cognitive Mapping
timeFrame: through study completion (4 weeks) and one time follow-up at an average of 6 months
Other outcomes:
measure: Weight
timeFrame: through study completion (4 weeks) and one time follow-up at an average of 6 months
Locations:
city: Galveston
country: United States
facility: School of Health Professions at the University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Lynne C Hughes, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: