PneumoniaNCT04114331
Feasibility of a Physical Therapy Intervention on Older Adults With Hyperkyphosis or Forward Head Posture
A study testing Manual therapy and exercise in people with Pneumonia and COPD, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Pneumonia, COPD, Hyperkyphosis
- What is being tested?
- Manual therapy and exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2018to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
School of Health Professions at the University of Texas Medical Branch
Galveston, Texas, 77555-1144
About this study
Official title: Feasibility of a Post-Hospitalization PT Intervention in Patients With Pneumonia
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.
Read the 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.
- Conditions
- Pneumonia, COPD, Hyperkyphosis, Postural, Thoracic Kyphosis
- Being tested
- Manual therapy and exercise
- Keywords
- forward head posture
- Medical subject headings
- Pneumonia, Pulmonary Disease, Chronic Obstructive, Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapy and exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy and exercise | Experimental | 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. Receives: Other: Manual therapy and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posture, as measured by change in height
Height in cm
Measured: through study completion (4 weeks) and one time follow-up at an average of 6 months
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.
Measured: through study completion (4 weeks) and one time follow-up at an average of 6 months
Posture, as measured by change in block test
height of blocks (measured in cm) under the head with participant supine
Measured: through study completion (4 weeks) and one time follow-up at an average of 6 months
Posture, visual change in digital photos
Digital photo in standing anterior and side views as well as supine view
Measured: through study completion (4 weeks) and one time follow-up at an average of 6 months
Secondary outcomes (9)
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.
Measured: through study completion (4 weeks) and one time follow-up at an average of 6 months
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.
Measured: through study completion (4 weeks) and one time follow-up at an average of 6 months
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.
Measured: through study completion (4 weeks) and one time follow-up at an average of 6 months
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
Measured: through study completion (4 weeks) and one time follow-up at an average of 6 months
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)
Measured: through study completion (4 weeks) and one time follow-up at an average of 6 months
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)
Measured: through study completion (4 weeks) and one time follow-up at an average of 6 months
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.
Measured: through study completion (4 weeks) and one time follow-up at an average of 6 months
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.
Measured: through study completion (4 weeks) and one time follow-up at an average of 6 months
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.
Measured: through study completion (4 weeks) and one time follow-up at an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start26 Feb 2018
- Primary completion18 Apr 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lynne C Hughes, PhD, PT, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114331
- Sponsor's protocol ID
- 15-0098
- Status last verified
- Aug 2019
- First submitted
- 16 Sep 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hughes LC, Ellis AL, Rogers HL, Hadley M, Galloway RV. A secondary analysis of gait after a 4-week postural intervention for older adults with hyperkyphosis. BMC Musculoskelet Disord. 2025 Feb 11;26(1):136. doi: 10.1186/s12891-025-08330-7.
PubMed 39934800Hughes LC, Galloway RV, Fisher SR. Feasibility of a 4-Week Manual Therapy and Exercise Intervention on Posture and Function in Community-Dwelling Older Adults: A Pilot Study. J Geriatr Phys Ther. 2022 Jul-Sep 01;46(3):151-160. doi: 10.1519/JPT.0000000000000360. Epub 2022 Aug 5.
PubMed 35939663
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Post-Hospitalization PT Intervention in Patients With Pneumonia
- ClinicalTrials.gov ID
- NCT04114331
- Acronym / sponsor ID
- 15-0098
- Conditions
- Pneumonia, COPD, Hyperkyphosis, Postural, Thoracic Kyphosis
- Keywords
- forward head posture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 18 Apr 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Manual therapy and exercise | Experimental | Other: Manual therapy and exerciseThe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual therapy and exerciseManual 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. | Other | Manual therapy and exercise |
Primary outcome
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
Height in cm
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
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
Time frame: through study completion (4 weeks) and one time follow-up at an average of 6 months
height of blocks (measured in cm) under the head with participant supine
Posture, visual change in digital photos
Time frame: through study completion (4 weeks) and one time follow-up at an average of 6 months
Digital photo in standing anterior and side views as well as supine view
9 secondary outcomes
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
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
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
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
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
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
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
Pulmonary function change measure by spirometry
Time frame: through study completion (4 weeks) and one time follow-up at an average of 6 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Derived from this study: PubMed 39934800Hughes LC, Ellis AL, Rogers HL, Hadley M, Galloway RV. A secondary analysis of gait after a 4-week postural intervention for older adults with hyperkyphosis. BMC Musculoskelet Disord. 2025 Feb 11;26(1):136. doi: 10.1186/s12891-025-08330-7.
- Derived from this study: PubMed 35939663Hughes LC, Galloway RV, Fisher SR. Feasibility of a 4-Week Manual Therapy and Exercise Intervention on Posture and Function in Community-Dwelling Older Adults: A Pilot Study. J Geriatr Phys Ther. 2022 Jul-Sep 01;46(3):151-160. doi: 10.1519/JPT.0000000000000360. Epub 2022 Aug 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynne C Hughes, PhD, PT principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy and exercise in people with Pneumonia and COPD, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04114331, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.