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Completed

NCT Number: NCT04114331

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

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.

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Key information

Conditions

Pneumonia Bone Diseases COPD Chronic Disease Disease Attributes Hyperkyphosis Infections Kyphosis Lung Diseases Lung Diseases, Obstructive Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postural, Thoracic Kyphosis Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Infections Spinal Curvatures Spinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Health Professions at the University of Texas Medical Branch

Galveston, Texas, 77555-1144, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual Therapy and Exercise

Other

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 outcomes

  1. 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

  2. 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.

  3. 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

  4. 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

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

  4. 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

    2MWT is the measured as the distance (feet) covered in 2 minutes

  5. 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

    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)

  6. 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

    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)

  7. 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

    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.

  8. Pulmonary function change measure by spirometry

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

    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.

  9. 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

    Cognitive mapping provides the issues, concerns, and perceptions of the participants of how posture affects their life. Measured by words recorded and qualitative analysis.

Other outcomes

  1. Weight

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

    measured in pounds

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Official study title

Feasibility of a Post-Hospitalization PT Intervention in Patients With Pneumonia

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 3, 2019
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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