Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

COPD Online Rehabilitation (CORe) (CORe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02667171
Recruitment Status : Completed
First Posted : January 28, 2016
Last Update Posted : March 26, 2020
Sponsor:
Collaborators:
TrygFonden, Denmark
Danish Lung Association
Region Capital Denmark
University of Copenhagen
Information provided by (Responsible Party):
Henrik Hansen, University Hospital Bispebjerg and Frederiksberg

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. 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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Behavioral: Supervised COPD Rehabilitation (control group) Behavioral: Online COPD rehabilitation (experimental) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study is a randomized controlled, assessor- and statistician blinded, superiority, multicentre trial with two parallel-groups. Online COPD Rehab versus Coventional COPD rehab
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:

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).

Primary Purpose: Treatment
Official Title: COPD Online Rehabilitation (CORe) - a Randomized, Multicenter Telemedicine Intervention Study
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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.





Primary Outcome Measures :
  1. Change in 6-Minute Walk Test Distance (6MWT) [ Time Frame: baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up) ]
    In-clinic test that measures exercise capacity


Secondary Outcome Measures :
  1. Change in 30 second sit-to-stand test (30-STST) [ Time Frame: baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up) ]
    In-clinic test that measures muscle endurance/strength

  2. Change in Activity level (ActivPAL) [ Time Frame: 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) ]
    Worn by the patients around the clock for 5 days in a private home.

  3. Change in Clinical COPD Questionaire (CCQ) [ Time Frame: baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up) ]
    Patient completed questionnaires that assess quality of life and COPD symptoms. Ten Item questionaire with total score from 0-60 points.

  4. Change in COPD Assessment Test (CAT) [ Time Frame: baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up) ]
    Patient completed questionnaires that assess quality of life and COPD symptoms. Five item questionaire with total score from 0-40 points.

  5. Change in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up) ]
    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

  6. Change in Euro Qol (EQ5D) [ Time Frame: baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up) ]
    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

  7. Total attendance in rehabilitation [ Time Frame: after 10 weeks ]
    registered

  8. number of hospital admissions [ Time Frame: 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) ]
    from registers

  9. Number of hospital days [ Time Frame: 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) ]
    from registers

  10. Outpatient visits in hospital and at general practioner [ Time Frame: 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) ]
    from registers

  11. Mortality [ Time Frame: 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) ]
    from registers



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02667171


Locations
Layout table for location information
Denmark
Bispebjerg and Frederiksberg Hospital
Copenhagen, Copenhagen Northwest, Denmark, 2400
Amager Hospital
Copenhagen, Denmark, 2300
Frederikssund hospital
Frederikssund, Denmark, 3600
Gentofte Hospital
Hellerup, Denmark, 2900
Herlev Hospital
Herlev, Denmark, 2739
Hillerød hospital
Hillerød, Denmark, 3400
Hvidovre Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
University Hospital Bispebjerg and Frederiksberg
TrygFonden, Denmark
Danish Lung Association
Region Capital Denmark
University of Copenhagen
Investigators
Layout table for investigator information
Study Chair: Anne Frølich, MD, PhD Research Unit for Chronic Diseases and Telemedicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Henrik Hansen, Ph.D. student, Physiotherapist, Master of Health Sciences, Project Manager,, University Hospital Bispebjerg and Frederiksberg
ClinicalTrials.gov Identifier: NCT02667171    
Other Study ID Numbers: E-12910 01-01-01
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: 31st of December 2021
Access Criteria: please res plan description above
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive