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

Chronic Obstructive Pulmonary Disease Moderate Clinical Trial

Official title:

Including Manual Therapy in Pulmonary Rehabilitation Programs for US Veterans With Moderate Chronic Obstructive Pulmonary Disease: A Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04386590
• Other study ID #: 1474325
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: June 15, 2022
• Est. completion date: November 2, 2023

Study information

• Verified date: March 2022
• Source: Canandaigua VA Medical Center
• Contact: Paul E Dougherty, DC
• Phone: 315-945-7381
• Email: paul.dougherty[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 2, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease Moderate
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Manual Therapy Plus Pulmonary Rehabilitation
Manual therapy combined with Pulmonary Rehabilitation
• Sham Intervention
Detuned US plus Pulmonary Rehabilitation

Locations

Country	Name	City	State
United States	Syracuse VA Medical Center	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
Canandaigua VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spirometry	Lung function (Forced expiratory volume in the 1st second: FEV1 and forced vital capacity: FVC) will be assessed using spirometry.	Change from Baseline to Post Intervention (4 weeks post baseline)
Secondary	6 Minute Walking Test (6MWT)	Exercise capacity will be assessed using a six-minute walking test (6MWT) where capacity is determined by the total distance walked in a period of six minutes. Greater walking distance indicates greater functional capacity.	Change from baseline to post intervention (4 weeks post baseline)
Secondary	St Georges Respiratory Questionnaire: SGRQ	Quality of life questionnaire for those with COPD. Scores are calculated for three domains: Symptoms, activity and Impacts (psychosocial) and total score. Higher scores indicate more limitations.	Change from baseline to post intervention (4 weeks post baseline)
Secondary	Hospital Anxiety and Depression scale: HAD	Questionnaire assessing anxiety and depression in outpatient hospital setting. Higher scores indicate greater levels of anxiety and depression.	Change from baseline to post intervention (4 weeks post baseline)