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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease Moderate
• Intervention / Treatment: Other: Sham Intervention; Other: Manual Therapy Plus Pulmonary Rehabilitation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Paul E Dougherty, DC; Phone Number: 315-945-7381; Email: paul.dougherty@va.gov
• Study Contact Backup: Name: Emily McCormick, BS; Phone Number: 53538 315-425-4400; Email: emily.mccormick@va.gov

Study Locations

• United States
  • New York
    • Syracuse, New York, United States, 13210
      • Recruiting
      • Syracuse VA Medical Center
      • Contact: Emily McCormick, BA; Phone Number: 53538 315-425-4400; Email: emily.mccormick@va.gov
      • Contact: Lori Gould, BA; Phone Number: 53538 315-425-4400; Email: lori.gould@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: 'Sham' manual therapy plus Pulmonary Rehabilitation (PR); Treadmill walking, upper body exercise machine, light weight training and bicycle. These exercises are supervised. In addition to the standard exercise therapy, all participants will undergo a 20-minute session consisting of discussion with the patient and 11 minutes of detuned ultrasound, which has been used in previous studies to account for time and attention for the patient. The detuned ultrasound procedure is to apply the ultrasound gel and turn the machine on, but set the intensity at zero (0) W/cm2	Other: Sham Intervention; Detuned US plus Pulmonary Rehabilitation
Experimental: Manual therapy plus Pulmonary Rehabilitation (CMT+; Manual therapy is made up of gentle Effleurage and cross-fibre friction massage applied to the muscles of the posterior chest wall. Manual Therapy consists of two separate manipulations (Grade V mobilization). Each manipulation involves the delivery of a high-velocity low amplitude (HVLA) posterior to anterior force directed at the inter-vertebral, costo-vertebral and costo-transverse joints. The first manipulation is delivered at the level of the upper/middle thoracic spine while the second is at the level of the middle/lower thoracic spine. In addition to the MT, the participant will also undergo Pulmonary Rehab as previously described.	Other: Manual Therapy Plus Pulmonary Rehabilitation; Manual therapy combined with Pulmonary Rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: Canandaigua VA Medical Center
• Investigators: Principal Investigator: Paul E Dougherty, DC, VA Finger Lakes Healthcare System

Study record dates

Study Major Dates

• Study Start (Anticipated): June 15, 2022
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): November 2, 2023

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: manual therapy; respiratory therapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 1474325

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to the phase of this study, the data will be utilized to inform the design of a larger clinical trial. Data from the larger study will be available to share de-identified data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No