COPD Online Rehabilitation (CORe)

University Hospital Bispebjerg and Frederiksberg

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Behavioral: Online COPD rehabilitation (experimental); Behavioral: Supervised COPD Rehabilitation (control group)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02667171

E-12910 01-01-01

Details and patient eligibility

About

International and national publications emphasize that COPD rehabilitation is a key cornerstone in the standard treatment of COPD, based on more than 15 years of research in COPD rehabilitation. COPD rehabilitation improves quality of life, anxiety and depression and physical function. COPD rehabilitation including special physical training, patient-directed education and smoking cessation is core rehabilitation elements, which today are recommended as mandatory content in standard COPD rehabilitation.

Standard COPD rehabilitation is an established offer in all regions and municipalities in Denmark. It is however a well-known challenge, that persons with the most severe COPD symptoms and co-morbidities are most likely not to receive COPD rehabilitation. Frequent exacerbations, socially isolation, transport distance to rehabilitation are main reasons why people with severe COPD disease deliberately chooses not to receive COPD rehabilitation. Why there at present are no rehabilitation alternatives for patients with the most severe COPD symptoms, supervised COPD Online rehabilitation in groups, delivered by health professionals in the COPD patients' own home via a computer screen could likely encourage more people to participate. The number of RCT's investigating the effect of supervised Online delivered COPD rehabilitation in groups versus established COPD rehabilitation are very limited.

The purpose of this randomized study is to investigate the short-term and long-term efficacy of 10 weeks of online COPD rehabilitation versus conventional supervised COPD rehabilitation in people with severe and very severe COPD. The outcome of the intervention is measured on walking distance, muscle endurance, activity level, quality of life and COPD symptoms respectively. Outcomes are measures before intervention start, end of intervention. This study also collects follow-up update after 3, 6 and 12 month. The follow-up data will be in separate publication.

Hypothesis

1. COPD online rehabilitation provides significant larger improvements than the usual care on walking distance, muscle endurance, activity level, and quality of life and COPD symptoms in people with severe and very severe COPD.
2. COPD online rehabilitation and conventional COPD rehabilitation, provides clinically relevant improvement on walking distance, muscle endurance, activity level, quality of life and COPD symptoms in people with severe and very severe COPD.

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of COPD defined as a ratio of forced expiratory volume at one second (FEV1) to forced vital capacity < 0.70
• FEV1 <50%, corresponding to severe or very severe COPD
• Symptoms equivalent to the Medical Research Council (MRC) from 2 to 5

Exclusion criteria

• Concurrent participation in or recent completion of pulmonary rehabilitation within the last six months.
• Dementia/ Cognitive impairment or uncontrolled psychiatric illness,
• An impaired hearing and / or vision which causes the instructions in the rehabilitation is not understood.
• Unable to understand and / or speak Danish.
• Unable to read Danish.
• Severe co-morbidity that are contraindicated to rhe clinical exercise protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

134 participants in 2 patient groups

Control group

Active Comparator group

Description:

The control group will receive standardized conventional supervised COPD rehabilitation, delivered in groups. Rehabilitation contains exercise training and education sessions twice a week for a duration of 8-12 weeks.

Treatment:

Behavioral: Supervised COPD Rehabilitation (control group)

Online COPD rehabilitation

Experimental group

Description:

Supervised Online COPD rehabilitation, delivered in groups through a computer screen in patients own home. Rehabilitation contains exercise training and education sessions three times per week for a duration of 10 weeks.

Treatment:

Behavioral: Online COPD rehabilitation (experimental)