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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

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

NCT ID

NCT04114331

First Posted

September 16, 2019

Last Updated

February 3, 2020

Sponsor

The University of Texas Medical Branch, Galveston

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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

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

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

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

Learn more about this trial

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

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