Clinical trial NCT04386590: Manual Therapy in Addition to Pulmonary Rehabilitation in Moderate Chronic Obstructive Pulmonary Disease.
Official title: Including Manual Therapy in Pulmonary Rehabilitation Programs for US Veterans With Moderate Chronic Obstructive Pulmonary Disease: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Chronic Obstructive Pulmonary Disease Moderate
Keywords: manual therapy
respiratory therapy
Lead sponsor: Canandaigua VA Medical Center
Sponsor class: FED
First posted: 2020-05-13
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Spirometry
timeFrame: Change from Baseline to Post Intervention (4 weeks post baseline)
Secondary outcomes:
measure: 6 Minute Walking Test (6MWT)
timeFrame: Change from baseline to post intervention (4 weeks post baseline)
measure: St Georges Respiratory Questionnaire: SGRQ
timeFrame: Change from baseline to post intervention (4 weeks post baseline)
measure: Hospital Anxiety and Depression scale: HAD
timeFrame: Change from baseline to post intervention (4 weeks post baseline)
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Syracuse VA Medical Center
state: New York
Study officials:
affiliation: VA Finger Lakes Healthcare System
name: Paul E Dougherty, DC
role: PRINCIPAL_INVESTIGATOR
References: