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

Primary Purpose

Pneumonia, COPD, Hyperkyphosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Manual therapy and exercise
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring forward head posture

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • School of Health Professions at the University of Texas Medical Branch

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Manual therapy and exercise

Arm Description

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.

Outcomes

Primary Outcome Measures

Posture, as measured by change in height
Height in cm
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.
Posture, as measured by change in block test
height of blocks (measured in cm) under the head with participant supine
Posture, visual change in digital photos
Digital photo in standing anterior and side views as well as supine view

Secondary Outcome Measures

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.
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.
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.
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
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)
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)
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.
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.
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.

Full Information

First Posted
September 16, 2019
Last Updated
February 3, 2020
Sponsor
The University of Texas Medical Branch, Galveston
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1. Study Identification

Unique Protocol Identification Number
NCT04114331
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 26, 2018 (Actual)
Primary Completion Date
April 18, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, COPD, Hyperkyphosis, Postural, Thoracic Kyphosis
Keywords
forward head posture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual therapy and exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Manual therapy and exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Posture, as measured by change in height
Description
Height in cm
Time Frame
through study completion (4 weeks) and one time follow-up at an average of 6 months
Title
Posture, as measured by change in kyphotic index
Description
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.
Time Frame
through study completion (4 weeks) and one time follow-up at an average of 6 months
Title
Posture, as measured by change in block test
Description
height of blocks (measured in cm) under the head with participant supine
Time Frame
through study completion (4 weeks) and one time follow-up at an average of 6 months
Title
Posture, visual change in digital photos
Description
Digital photo in standing anterior and side views as well as supine view
Time Frame
through study completion (4 weeks) and one time follow-up at an average of 6 months
Secondary Outcome Measure Information:
Title
Function as a change in Timed Up and Go speed
Description
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.
Time Frame
through study completion (4 weeks) and one time follow-up at an average of 6 months
Title
Function as a change in Functional Reach test
Description
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.
Time Frame
through study completion (4 weeks) and one time follow-up at an average of 6 months
Title
Function as a change in the Short Physical Performance Battery (SPPB) score
Description
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.
Time Frame
through study completion (4 weeks) and one time follow-up at an average of 6 months
Title
Function and Gait as a change in the 2 Minute Walk Test (2MWT)
Description
2MWT is the measured as the distance (feet) covered in 2 minutes
Time Frame
through study completion (4 weeks) and one time follow-up at an average of 6 months
Title
Function and patient perception as change in the Patient Specific Functional Scale (PSFS)
Description
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)
Time Frame
through study completion (4 weeks) and one time follow-up at an average of 6 months
Title
Gait as measured by change in gait parameters on a Gaitrite walkway
Description
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)
Time Frame
through study completion (4 weeks) and one time follow-up at an average of 6 months
Title
Gait as measured by change in Tekscan measures of force
Description
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.
Time Frame
through study completion (4 weeks) and one time follow-up at an average of 6 months
Title
Pulmonary function change measure by spirometry
Description
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.
Time Frame
through study completion (4 weeks) and one time follow-up at an average of 6 months
Title
Patient perception as measured by changes in Cognitive Mapping
Description
Cognitive mapping provides the issues, concerns, and perceptions of the participants of how posture affects their life. Measured by words recorded and qualitative analysis.
Time Frame
through study completion (4 weeks) and one time follow-up at an average of 6 months
Other Pre-specified Outcome Measures:
Title
Weight
Description
measured in pounds
Time Frame
through study completion (4 weeks) and one time follow-up at an average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynne C Hughes, PhD, PT
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Health Professions at the University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-1144
Country
United States

12. IPD Sharing Statement

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

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