COPD Online Rehabilitation (CORe)

Pulmonary Disease, Chronic Obstructive Clinical Trial

— CORe  

Official title:

COPD Online Rehabilitation (CORe) - a Randomized, Multicenter Telemedicine Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02667171
• Other study ID #: E-12910 01-01-01
• Status: Completed
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: University Hospital Bispebjerg and Frederiksberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Supervised COPD Rehabilitation (control group)
The control group receives standardized conventional supervised COPD rehabilitation (CCR) in groups. Rehabilitation contains exercise training and education sessions twice a week for a duration of 8-12 weeks. The CCR will last 60-120 minutes each session (50% exercise and 50% education). Physical Exercises in CCR consist endurance based at Borg dyspnea 4-7 for 20-30 minutes and resistance training for upper and lower limb at 50-80% of one repetition maximum of 2-3 sets. Educations sessions consist information a dialogue regarding, life with COPD, participants topics, Medication, daily activity, Nutrition, Smoking cessation, Respiratory and relaxation exercises.
• Online COPD rehabilitation (experimental)
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. Each session lasts for 60minutes (60% exercise 40% education). Physical exercises consist high repetitive time-based muscle endurance training, including 5-7 upper and lower limb exercises, performed with a volume of four sets per exercise equivalent to 50-80% of one repetition. Self-rated Borg CR-10 score equivalent from moderate to very strong shortness of breath in active phases. Educations consists same information as for the control group.

Locations

Country	Name	City	State
Denmark	Amager Hospital	Copenhagen
Denmark	Bispebjerg and Frederiksberg Hospital	Copenhagen	Copenhagen Northwest
Denmark	Frederikssund hospital	Frederikssund
Denmark	Gentofte Hospital	Hellerup
Denmark	Herlev Hospital	Herlev
Denmark	Hillerød hospital	Hillerød
Denmark	Hvidovre Hospital	Hvidovre

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital Bispebjerg and Frederiksberg	Danish Lung Association, Region Capital Denmark, TrygFonden, Denmark, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 6-Minute Walk Test Distance (6MWT)	In-clinic test that measures exercise capacity	baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up)
Secondary	Change in 30 second sit-to-stand test (30-STST)	In-clinic test that measures muscle endurance/strength	baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up)
Secondary	Change in Activity level (ActivPAL)	Worn by the patients around the clock for 5 days in a private home.	Worn by the patients around the clock for 5 days in a private home at baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up)
Secondary	Change in Clinical COPD Questionaire (CCQ)	Patient completed questionnaires that assess quality of life and COPD symptoms. Ten Item questionaire with total score from 0-60 points.	baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up)
Secondary	Change in COPD Assessment Test (CAT)	Patient completed questionnaires that assess quality of life and COPD symptoms. Five item questionaire with total score from 0-40 points.	baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up)
Secondary	Change in Hospital Anxiety and Depression Scale (HADS)	Patient completed questionnaires that assess anxiety and depression symptoms. Seven item domain questions for depression with total score form 0-21 point. Seven item domain questions for anxiety with total score fra 0-21 points. Total score from 0-42 points	baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up)
Secondary	Change in Euro Qol (EQ5D)	Patient completed questionnaires that assess quality of life. Total score fra 0-1 on EQ5D-health domain. Total score from 0-100mm on EQ5D-vas domain. No total domain score	baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up)
Secondary	Total attendance in rehabilitation	registered	after 10 weeks
Secondary	number of hospital admissions	from registers	number of hospital admissions - after 10 weeks, after 22 weeks (average of 3 month follow up), after 36 weeks (average of 6 month follow up), after 62 weeks (average of 12 month follow up)
Secondary	Number of hospital days	from registers	number of hospital days - after 10 weeks, after 22 weeks (average of 3 month follow up), after 36 weeks (average of 6 month follow up), after 62 weeks (average of 12 month follow up)
Secondary	Outpatient visits in hospital and at general practioner	from registers	number of outpatients visits in hospital and at general practioner - after 10 weeks, after 22 weeks (average of 3 month follow up), after 36 weeks (average of 6 month follow up), after 62 weeks (average of 12 month follow up)
Secondary	Mortality	from registers	after 10 weeks, after 22 weeks (average of 3 month follow up), after 36 weeks (average of 6 month follow up), after 62 weeks (average of 12 month follow up)