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NCT Number: NCT02667171

COPD Online Rehabilitation (CORe)

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg and Frederiksberg Hospital, Copenhagen, Copenhagen Northwest, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital Bispebjerg and Frederiksberg

Other

Collaborators

  • Danish Lung Association
  • Region Capital Denmark
  • TrygFonden, Denmark
  • University of Copenhagen

Registry information

Official study title

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

Acronym: CORe

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jan 28, 2016
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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