The effect of combining manual therapy with exercise for stable mild chronic obstructive pulmonary disease: a randomised controlled trial

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000766617

Acronym

MT COPD trial

Enrollment

Registered

2014-07-18

Start date

2014-11-04

Completion date

2018-05-20

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to measure the medium to long term effects on lung function, exercise capacity and quality of life of a new combination of interventions for people with COPD. The interventions are manual therapy and exercise. The rationale behind the study is that manual therapy delivers short-term improvements in respiratory mechanics which delays the onset of exercise-induced breathlessness. This permits an increase in exercise performance and ultimately exercise capacity. As exercise capacity is an indicator of mortality in COPD, any increase represents an improvement in the long-term prognosis of the disease.

Interventions

Arm 1: Exercise Arm 2: Manual therapy and exercise Exercise: 36 x 30 minute exercise sessions over an 18 week period at an average rate of 2x/week. Administered by respiratory physiotherapists. Exercise consists of gentle aerobic exercise routines. Manual Therapy: 15 x 20 minute manual therapy sessions over a 6 week period at an average rate of 2-3x/week. Administered by chiropractors and/or osteopaths. Manual therapy consists of massage and thoracic spinal manipulation.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

50 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Existing diagnosis of mild COPD (60% < FEV1 < 80%) 2. Stable COPD (no exacerbations for preceding 6 months) 3. Current non-smoker (non-smoking for > 6 months)

Exclusion criteria

1. Inability to complete 6 minute walking test unassisted 2. History of auto-immune disease that may have permanently altered systemic inflammatory biomarkers 3. Contra-indication for thoracic spinal manipulation (Bone density T score < -2.5 and/or Z score < -1) 4. Thoracic joint instability 5. Acute pain on thoracic joint range of motion testing 6. Below normal chest wall musculature for age and gender 7. High level of anxiety related to receiving thoracic spinal manipulation 8. Completed a pulmonary rehabilitation program within the previous 12 months

Outcome results