- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04114331
Feasibility of a Physical Therapy Intervention on Older Adults With Hyperkyphosis or Forward Head Posture
Feasibility of a Post-Hospitalization PT Intervention in Patients With Pneumonia
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Galveston, Texas, United States, 77555-1144
- School of Health Professions at the University of Texas Medical Branch
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Manual therapy and exercise
The intervention (3 times a week for 4 weeks, for a total of 12 sessions) consisted primarily of manual therapy (soft tissue and joint mobilization) followed by therapeutic exercises (muscular control and coordination). Manual therapy: Joint mobilizations (Grades I-V) to cervical spine, thoracic spine and ribs Soft tissue mobilization to the pectoralis, scaleni, upper traps, thoracolumbar fascia, erector spinae, and suboccipital musculature Therapeutic exercises: Strengthening of mid and lower traps, lats, glut med, and glut max. Active & passive stretching of thoracic and lumbar rotation, hip flexors, and plantarflexors. The treating therapists agreed on a protocol with treatment individualized to each patient. |
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Posture, as measured by change in height
Time Frame: through study completion (4 weeks) and one time follow-up at an average of 6 months
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Height in cm
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through study completion (4 weeks) and one time follow-up at an average of 6 months
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Posture, as measured by change in kyphotic index
Time Frame: through study completion (4 weeks) and one time follow-up at an average of 6 months
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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.
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through study completion (4 weeks) and one time follow-up at an average of 6 months
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Posture, as measured by change in block test
Time Frame: through study completion (4 weeks) and one time follow-up at an average of 6 months
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height of blocks (measured in cm) under the head with participant supine
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through study completion (4 weeks) and one time follow-up at an average of 6 months
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Posture, visual change in digital photos
Time Frame: through study completion (4 weeks) and one time follow-up at an average of 6 months
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Digital photo in standing anterior and side views as well as supine view
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through study completion (4 weeks) and one time follow-up at an average of 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Function as a change in Timed Up and Go speed
Time Frame: through study completion (4 weeks) and one time follow-up at an average of 6 months
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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.
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through study completion (4 weeks) and one time follow-up at an average of 6 months
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Function as a change in Functional Reach test
Time Frame: through study completion (4 weeks) and one time follow-up at an average of 6 months
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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.
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through study completion (4 weeks) and one time follow-up at an average of 6 months
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Function as a change in the Short Physical Performance Battery (SPPB) score
Time Frame: through study completion (4 weeks) and one time follow-up at an average of 6 months
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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.
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through study completion (4 weeks) and one time follow-up at an average of 6 months
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Function and Gait as a change in the 2 Minute Walk Test (2MWT)
Time Frame: through study completion (4 weeks) and one time follow-up at an average of 6 months
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2MWT is the measured as the distance (feet) covered in 2 minutes
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through study completion (4 weeks) and one time follow-up at an average of 6 months
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Function and patient perception as change in the Patient Specific Functional Scale (PSFS)
Time Frame: through study completion (4 weeks) and one time follow-up at an average of 6 months
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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)
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through study completion (4 weeks) and one time follow-up at an average of 6 months
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Gait as measured by change in gait parameters on a Gaitrite walkway
Time Frame: through study completion (4 weeks) and one time follow-up at an average of 6 months
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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)
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through study completion (4 weeks) and one time follow-up at an average of 6 months
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Gait as measured by change in Tekscan measures of force
Time Frame: through study completion (4 weeks) and one time follow-up at an average of 6 months
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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.
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through study completion (4 weeks) and one time follow-up at an average of 6 months
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Pulmonary function change measure by spirometry
Time Frame: through study completion (4 weeks) and one time follow-up at an average of 6 months
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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.
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through study completion (4 weeks) and one time follow-up at an average of 6 months
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Patient perception as measured by changes in Cognitive Mapping
Time Frame: through study completion (4 weeks) and one time follow-up at an average of 6 months
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Cognitive mapping provides the issues, concerns, and perceptions of the participants of how posture affects their life.
Measured by words recorded and qualitative analysis.
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through study completion (4 weeks) and one time follow-up at an average of 6 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight
Time Frame: through study completion (4 weeks) and one time follow-up at an average of 6 months
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measured in pounds
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through study completion (4 weeks) and one time follow-up at an average of 6 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Lynne C Hughes, PhD, PT, University of Texas
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-0098
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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