NCT04114331

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 26, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 3, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

February 5, 2020

Status Verified

August 1, 2019

Enrollment Period

1.1 years

First QC Date

September 16, 2019

Last Update Submit

February 3, 2020

Conditions

Keywords

forward head posture

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (9)

  • Function as a change in Timed Up and Go speed

    through study completion (4 weeks) and one time follow-up at an average of 6 months

  • Function as a change in Functional Reach test

    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

    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)

    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)

    through study completion (4 weeks) and one time follow-up at an average of 6 months

  • +4 more secondary outcomes

Other Outcomes (1)

  • Weight

    through study completion (4 weeks) and one time follow-up at an average of 6 months

Study Arms (1)

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.

Other: Manual therapy and exercise

Interventions

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.

Manual therapy and exercise

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Health Professions at the University of Texas Medical Branch

Galveston, Texas, 77555-1144, United States

Location

Related Publications (2)

  • 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.

  • Hughes 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.

MeSH Terms

Conditions

PneumoniaPulmonary Disease, Chronic ObstructiveKyphosis

Interventions

Musculoskeletal ManipulationsExercise

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSpinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Lynne C Hughes, PhD, PT

    University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2019

First Posted

October 3, 2019

Study Start

February 26, 2018

Primary Completion

April 18, 2019

Study Completion

December 20, 2019

Last Updated

February 5, 2020

Record last verified: 2019-08

Locations