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

NCT04386590 | Unknown Phase 2

• 1 other identifier: 1474325
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease Moderate

Keywords

manual therapy; respiratory therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 6 Minute Walking Test (6MWT)

  Change from baseline to post intervention (4 weeks post baseline)

• St Georges Respiratory Questionnaire: SGRQ

  Change from baseline to post intervention (4 weeks post baseline)

• Hospital Anxiety and Depression scale: HAD

  Change from baseline to post intervention (4 weeks post baseline)

Study Arms (2)

'Sham' manual therapy plus Pulmonary Rehabilitation (PR)

SHAM COMPARATOR

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

Manual therapy plus Pulmonary Rehabilitation (CMT+

EXPERIMENTAL

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

Interventions

Manual Therapy Plus Pulmonary Rehabilitation OTHER

Manual therapy combined with Pulmonary Rehabilitation

Manual therapy plus Pulmonary Rehabilitation (CMT+

Sham Intervention OTHER

Detuned US plus Pulmonary Rehabilitation

'Sham' manual therapy plus Pulmonary Rehabilitation (PR)

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Canandaigua VA Medical Center: lead

Study Sites (1)

Syracuse VA Medical Center

Syracuse, New York, 13210, United States

RECRUITING

MeSH Terms

Interventions

Musculoskeletal Manipulations

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Paul E Dougherty, DC

  VA Finger Lakes Healthcare System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul E Dougherty, DC

CONTACT

315-945-7381; paul.dougherty@va.gov

Emily McCormick, BS

CONTACT

315-425-4400; emily.mccormick@va.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor will evaluate a de-identified database with the interventions labeled as 1 and 2.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Chiropractor

Model Details: 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.

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 13, 2020
• Study Start: June 15, 2022
• Primary Completion: May 31, 2023
• Study Completion: November 2, 2023
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)