COPD Online Rehabilitation (CORe) (CORe)

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Behavioral: Supervised COPD Rehabilitation (control group); Behavioral: Online COPD rehabilitation (experimental)

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2300
    • Amager Hospital
  • Frederikssund, Denmark, 3600
    • Frederikssund Hospital
  • Hellerup, Denmark, 2900
    • Gentofte Hospital
  • Herlev, Denmark, 2739
    • Herlev Hospital
  • Hillerød, Denmark, 3400
    • Hillerød Hospital
  • Hvidovre, Denmark, 2650
    • Hvidovre Hospital
  • Copenhagen Northwest
    • Copenhagen, Copenhagen Northwest, Denmark, 2400
      • Bispebjerg and Frederiksberg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; 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.	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.
Experimental: Online COPD rehabilitation; 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
Total attendance in rehabilitation	registered	after 10 weeks
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: University Hospital Bispebjerg and Frederiksberg
• Collaborators: University of Copenhagen; TrygFonden, Denmark; Danish Lung Association; Region Capital Denmark
• Investigators: Study Chair: Anne Frølich, MD, PhD, Research Unit for Chronic Diseases and Telemedicine

Publications and helpful links

General Publications

• Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1:CD013040. doi: 10.1002/14651858.CD013040.pub2.
• Hansen H, Bieler T, Beyer N, Kallemose T, Wilcke JT, Ostergaard LM, Frost Andeassen H, Martinez G, Lavesen M, Frolich A, Godtfredsen NS. Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation in severe COPD: a randomised multicentre trial. Thorax. 2020 May;75(5):413-421. doi: 10.1136/thoraxjnl-2019-214246. Epub 2020 Mar 30.
• Hansen H, Bieler T, Beyer N, Godtfredsen N, Kallemose T, Frolich A. COPD online-rehabilitation versus conventional COPD rehabilitation - rationale and design for a multicenter randomized controlled trial study protocol (CORe trial). BMC Pulm Med. 2017 Nov 16;17(1):140. doi: 10.1186/s12890-017-0488-1.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: January 12, 2016
• First Submitted That Met QC Criteria: January 25, 2016
• First Posted (Estimate): January 28, 2016

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: E-12910 01-01-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

Data are available upon reasonable request. Data sharing plan: Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation in severe COPD: a randomised multicentre trial. When and for how long the data will become/be available? Data available until 31 December 2021. Proposal for data use should be addressed to henrik. hansen. 09@ regionh. dk. Data access in Denmark are under very strict juristic data protection law. Any possible access or sharing demands a part application to; (1) Danish Data Protection Agency, (2) Ethics Committee of the Capital Region, (3) National Health Data Authorities.

Only if the applications are approved data will be considered available for sharing.

The authors will not be able to support this process and a prolonged process must be expected.

• IPD Sharing Time Frame: 31st of December 2021
• IPD Sharing Access Criteria: please res plan description above
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No