COPD Online Rehabilitation (CORe)

NCT02667171 | Completed DMC

• 1 other identifier: E-12910 01-01-01
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 7

Brief 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. 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. 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change in 30 second sit-to-stand test (30-STST)

  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 at baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up)

• Change in Clinical COPD Questionaire (CCQ)

  baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up)

• Change in COPD Assessment Test (CAT)

  baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up)

• Change in Hospital Anxiety and Depression Scale (HADS)

  baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up)

Study Arms (2)

Control group

ACTIVE COMPARATOR

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)

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.

Behavioral: Online COPD rehabilitation (experimental)

Interventions

Supervised COPD Rehabilitation (control group) BEHAVIORAL

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.

Control group

Online COPD rehabilitation (experimental) BEHAVIORAL

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.

Online COPD rehabilitation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead
• TrygFonden, Denmark: collaborator
• Danish Lung Association: collaborator
• Region Capital Denmark: collaborator
• University of Copenhagen: collaborator

Study Sites (7)

Bispebjerg and Frederiksberg Hospital

Copenhagen, Copenhagen Northwest, 2400, Denmark

Location

Amager Hospital

Copenhagen, 2300, Denmark

Location

Frederikssund hospital

Frederikssund, 3600, Denmark

Location

Gentofte Hospital

Hellerup, 2900, Denmark

Location

Herlev Hospital

Herlev, 2739, Denmark

Location

Hillerød hospital

Hillerød, 3400, Denmark

Location

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (3)

• 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(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.

  PMID: 33511633 DERIVED

• 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.

  PMID: 32229541 DERIVED

• 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.

  PMID: 29145831 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Anne Frølich, MD, PhD

  Research Unit for Chronic Diseases and Telemedicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All assessors are blinded to group allocation and previous test results. Due to the nature of the study the patients cannot be blinded, but prior to the assessments they are reminded not to disclose their group allocation to the assessors. In case of failure keeping the outcome assessor blinded (that is, if a participant reveals his/her allocation) a second assessor will be available to step in and conduct the assessment on another day. To avoid investigators (subconscious) bias the biostatistician who perform the data analyses and validate the results will be blinded to group allocation. The research group will interpret the results, and the conclusion will be prepared in two versions before the allocation code is broken (one assuming that arm A is the intervention, and one assuming that arm B is the intervention).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. student, Physiotherapist, Master of Health Sciences, Project Manager,

Model Details: This study is a randomized controlled, assessor- and statistician blinded, superiority, multicentre trial with two parallel-groups. Online COPD Rehab versus Coventional COPD rehab

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: January 28, 2016
• Study Start: March 1, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2019
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 31st of December 2021
• Access Criteria: please res plan description above

Locations

DK (7)