Feasibility of a Physical Therapy Intervention on Older Adults With Hyperkyphosis or Forward Head Posture

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04114331
• Other study ID #: 15-0098
• Status: Completed
• Phase: N/A
• Start date: February 26, 2018
• Est. completion date: December 20, 2019

Study information

• Verified date: August 2019
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 20, 2019
• Est. primary completion date: April 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Hyperkyphosis
• Kyphosis
• Pneumonia
• Postural, Thoracic Kyphosis

Intervention

Other:
• Manual therapy and exercise
Manual therapy consisting of soft tissue and joint mobilization to gain mobility. Therapeutic exercise was active motion and resisted motion to gain motor control and motor coordination in the new range.

Locations

Country	Name	City	State
United States	School of Health Professions at the University of Texas Medical Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight	measured in pounds	through study completion (4 weeks) and one time follow-up at an average of 6 months
Primary	Posture, as measured by change in height	Height in cm	through study completion (4 weeks) and one time follow-up at an average of 6 months
Primary	Posture, as measured by change in kyphotic index	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.	through study completion (4 weeks) and one time follow-up at an average of 6 months
Primary	Posture, as measured by change in block test	height of blocks (measured in cm) under the head with participant supine	through study completion (4 weeks) and one time follow-up at an average of 6 months
Primary	Posture, visual change in digital photos	Digital photo in standing anterior and side views as well as supine view	through study completion (4 weeks) and one time follow-up at an average of 6 months
Secondary	Function as a change in Timed Up and Go speed	Timed Up and Go as measured in seconds to performed standardized functional test. Participants are timed in seconds from sitting in a chair to standing, walking 3 meters, turning around, walking back, and sitting down.	through study completion (4 weeks) and one time follow-up at an average of 6 months
Secondary	Function as a change in Functional Reach test	Functional reach as measured in cm. It is performed by having the participant standing still and is instructed to reach forward as far as you can without taking a step.	through study completion (4 weeks) and one time follow-up at an average of 6 months
Secondary	Function as a change in the Short Physical Performance Battery (SPPB) score	SPPB score as determined by seconds to perform each component of this standardized test. This functional test has 3 components of 5 times sit to stand, gait speed, and balance. 5 times sit to stand is a standardized test of lower extremity strength that is performed by rising and sitting in a chair 5 times in a row. The activity is timed. Gait speed will be extracted from gaitrite data. Balance tests will be timed.	through study completion (4 weeks) and one time follow-up at an average of 6 months
Secondary	Function and Gait as a change in the 2 Minute Walk Test (2MWT)	2MWT is the measured as the distance (feet) covered in 2 minutes	through study completion (4 weeks) and one time follow-up at an average of 6 months
Secondary	Function and patient perception as change in the Patient Specific Functional Scale (PSFS)	PSFS is a standardized survey of activities that are difficult to perform (listed by participant) and to what degree as measured on a likert scale (0 to 10)	through study completion (4 weeks) and one time follow-up at an average of 6 months
Secondary	Gait as measured by change in gait parameters on a Gaitrite walkway	The gaitrite records a standard set of parameters. Change in gait speed (m/sec), step length (cm), stride length (cm), double limb support time (seconds), and step width (cm)	through study completion (4 weeks) and one time follow-up at an average of 6 months
Secondary	Gait as measured by change in Tekscan measures of force	Tekscan records a standard set of measures of time and force. Change in peak force at loading response, mid-stance, and terminal stance in newtons.	through study completion (4 weeks) and one time follow-up at an average of 6 months
Secondary	Pulmonary function change measure by spirometry	Spirometry provides standard measures of respiratory volume and volume in time. Changes in Forced Vital Capacity and Forced Expiratory Volume in 1 second were the measures of interest.	through study completion (4 weeks) and one time follow-up at an average of 6 months
Secondary	Patient perception as measured by changes in Cognitive Mapping	Cognitive mapping provides the issues, concerns, and perceptions of the participants of how posture affects their life. Measured by words recorded and qualitative analysis.	through study completion (4 weeks) and one time follow-up at an average of 6 months