Manual Therapy in Addition to Pulmonary Rehabilitation in Moderate Chronic Obstructive Pulmonary Disease.

  • STATUS
    Recruiting
  • End date
    Nov 2, 2023
  • participants needed
    20
  • sponsor
    Canandaigua VA Medical Center
Updated on 27 April 2022

Summary

The aim of this study is to investigate the feasibility of administering this combination of interventions (CMT plus PR) to Veterans with moderate COPD within the context of a hospital-based outpatient pulmonary rehabilitation program.

Description

In 2016, the US Congress directed the Department of Defense to initiate a program to improve the health and well-being of all military Veterans, challenging the research and scientific communities to find original ideas that "foster new directions in research and clinical care". One of the areas identified as a priority under this initiative was 'Respiratory Health'.

Chronic obstructive pulmonary disease (COPD) is a major cause of disability, hospital admission and premature death. Current management strategies have not been successful in altering the loss of lung function typically seen as the disease progresses. Results from recent pilot trials suggest the novel combination of chiropractic manual therapy (CMT) and pulmonary rehabilitation (PR) has the potential to alter the typical pattern of decline in lung function.

The aim of this study is to investigate the feasibility of administering this combination of interventions (CMT plus PR) to Veterans with moderate COPD within the context of a hospital-based outpatient pulmonary rehabilitation program.

Twenty Veterans between the ages of 50 and 70 years with moderate COPD, will be randomly allocated to two equal groups. Group 1: 'sham' manual therapy plus pulmonary rehabilitation program; Group 2: Chiropractic manual therapy group plus the same pulmonary rehabilitation program (CMT+PR). Participants in both groups will undergo 8 treatment sessions over a 4 week period plus an additional assessment session at week 8. All sham manual therapy and CMT will be delivered just prior to pulmonary rehabilitation.

The primary purpose of the study is to assess the feasibility of conducting a larger randomized controlled trial by assessing the ability to recruit, enroll, deliver interventions and collect outcome measures on Veterans with moderate COPD. Secondary outcomes include lung function (Forced expiratory volume in the 1st second: FEV1 and Forced vital capacity: FVC), exercise capacity (six-minute walking test: 6MWT), quality of life (St Georges Respiratory Questionnaire: SGRQ), anxiety and depression levels (Hospital Anxiety and Depression scale: HAD) and frequency of exacerbations. All outcome measurements will be taken by blinded assessors.

Collecting outcome measurements at 8 weeks (4 weeks after intervention has ceased) will assess the feasibility of getting Veterans to return for follow-up assessments.

Details
Condition Chronic Obstructive Pulmonary Disease Moderate
Treatment sham intervention, Manual Therapy Plus Pulmonary Rehabilitation
Clinical Study IdentifierNCT04386590
SponsorCanandaigua VA Medical Center
Last Modified on27 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Sex: Male and Female
Age range: 50-70 years
Disease status: Moderate COPD (FEV1% predicted: moderate 50-80% (GOLD 2018))
Concomitant disease status: Stable COPD (no exacerbations in preceding 6 months) Non-smoking (for preceding 6 months)
Willingness to give written informed consent
Willingness to participate in and comply with the study requirements

Exclusion Criteria

Inability to complete 6-minute walking test unassisted
Contra-indicated to thoracic spinal manipulation
Thoracic joint instability
Acute pain on thoracic joint range of motion testing
High level of anxiety related to receiving thoracic spinal manipulation
Inability to understand English
People with a cognitive impairment, an intellectual disability or a mental illness
Completed a pulmonary rehabilitation program in the previous 12 months
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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