The Role of Ambulatory Oxygen in Improving the Effectiveness of Pulmonary Rehabilitation for COPD Patients

NCT02707770 | Terminated Results

• 1 other identifier: 15SM3060
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary rehabilitation (PR) is an exercise program tailored for patients with chronic lung disease that is a core part of the management of patients with Chronic Obstructive Pulmonary Disease (COPD). Many COPD patients develop low oxygen levels (desaturation) during exercise and this is often discovered when they are being evaluated for PR. Current practice is to administer oxygen to COPD patients with exercise-induced desaturation, but this is based on very limited evidence. This limited evidence relates to a short-term increase in exercise capacity and it is not known if this translates into longer term increases in activity or whether providing these patients with oxygen improves outcomes after PR. In addition it is not known if patients given ambulatory oxygen continue to use it after completing PR. Evidence for a beneficial effect of oxygen would provide a more solid evidence base for its use. Conversely demonstration of no effect would allow reassessment of the use of oxygen and whether the costs are justified. Therefore the aims of this study are to assess the effects of oxygen on outcomes from PR and assess the usage of ambulatory oxygen following completion of PR.

Conditions

Chronic Obstructive Pulmonary Diseases

Keywords

COPD, pulmonary rehabilitation, ambulatory oxygen therapy

Outcome Measures

Primary Outcomes (1)

• Change in Functional Exercise Capacity

  6 Minute Walk Test (6MWT)- Distance in meters

  0, 8weeks

Secondary Outcomes (6)

• Number of Participants Reporting a Change in the Quality of Life

  0,8weeks

• Number of Participants Reporting a Change in Anxiety Score

  0,8weeks

• Number of Participants Reporting Change in Depression Score

  0,8weeks

• Number of Participants Reporting Change in Chronic Obstructive Pulmonary Diseases Assessment Test (CAT)

  0,8weeks

• Number of Patients Reporting Change in Physical Activity

  8 weeks

Study Arms (2)

Ambulatory oxygen

EXPERIMENTAL

Patient will use ambulatory oxygen during pulmonary rehabilitation programme (flow rate determined at the initial assessment to a maximum flow rate of 6 litres per minute)

Other: Pulmonary Rehabilitation

Room air

PLACEBO COMPARATOR

Patient will breath on room air during pulmonary rehabilitation programme

Other: Pulmonary Rehabilitation

Interventions

Pulmonary Rehabilitation OTHER

Ambulatory oxygen; Room air

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• A confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
• Fulfil the clinical criteria for Pulmonary Rehabilitation (PR)
• Demonstrate exercise-induced desaturation (defined as a fall in SaO2 ≥4% to at least \<90%, or any fall to a SaO2 \<90%) and demonstrate positive improvement with use of ambulatory oxygen as per the British Thoracic Society 2015 Oxygen Guidelines

You may not qualify if:

• Use of long term oxygen therapy
• Unable to provide informed consent
• Significant respiratory disease other than COPD
• Any patient needing more than 6 litres per minute oxygen to correct desaturation
• Severe desaturation: SaO2 \< 80% during 6 Minute Walk Test
• Any absolute contraindication to Pulmonary Rehabilitation

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

St Marys Hospital

London, W2 21NY, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Due to study terminated prematurely, unable to recruit the intended number of participants and complete extra follow ups as proposed in the study protocol. Due to technical issue with pedometer device and validity of measurements, physical activity measurement was not included or analysed as part of the secondary outcome measure.

Results Point of Contact

• Title: vijay padmanaban
• Organization: Imperial college healthcare NHS trust

vijay.padmanaban@nhs.net

02033122349

Study Officials

• Vijayaragavan Padmanaban, MPT

  Imperial healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: March 14, 2016
• Study Start: April 14, 2016
• Primary Completion: June 19, 2017
• Study Completion: December 30, 2017
• Last Updated: March 30, 2021
• Results First Posted: March 30, 2021

Record last verified: 2021-03

Locations

GB (1)