COPD online-rehabilitation versus conventional COPD rehabilitation: rationale and design for a multicenter randomized controlled trial study protocol (CORe trial)
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COPD online-rehabilitation versus conventional COPD rehabilitation : rationale and design for a multicenter randomized controlled trial study protocol (CORe trial). / Hansen, Henrik; Bieler, Theresa; Beyer, Nina; Godtfredsen, Nina; Kallemose, Thomas; Frølich, Anne.
In: B M C Pulmonary Medicine, Vol. 17, 140, 2017.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - COPD online-rehabilitation versus conventional COPD rehabilitation
T2 - rationale and design for a multicenter randomized controlled trial study protocol (CORe trial)
AU - Hansen, Henrik
AU - Bieler, Theresa
AU - Beyer, Nina
AU - Godtfredsen, Nina
AU - Kallemose, Thomas
AU - Frølich, Anne
PY - 2017
Y1 - 2017
N2 - BACKGROUND: Rehabilitation of patients with chronic obstructive pulmonary disease (COPD) is a key treatment in COPD. However, despite the existing evidence and a strong recommendation from lung associations worldwide, 50% of patients with COPD decline to participate in COPD rehabilitation program and 30-50% drop-out before completion. The main reasons are severe symptoms, inflexible accessibility and necessity for transportation. Currently there are no well-established and evident rehabilitation alternatives. Supervised online screen rehabilitation could be a useful approach to increase accessibility and compliance. The aim of this multicenter RCT study is to compare the potential benefits of a 10-week online COPD rehabilitation program (CORe) with conventional outpatient COPD rehabilitation (CCRe).METHODS: This study is a randomized assessor- and statistician blinded superiority multicenter trial with two parallel groups, employing 1:1 allocation to the intervention and the comparison group.On the basis of a sample size calculation, 134 patients with severe or very severe COPD and eligible to conventional hospital based outpatient COPD rehabilitation will be included and randomized from eight different hospitals. The CORe intervention group receives group supervised resistance- and endurance training and patient education, 60 min, three times/week for 10 weeks at home via online-screen. The CCRe comparison group receives group based supervised resistance- and endurance training and patient education, 90 min, two times/week for 10 weeks (two hospitals) or 12 weeks (six hospitals) in groups at the local hospital. The primary outcome is change in the 6-min walking distance after 10/12 weeks; the secondary outcomes are changes in 30 s sit-to-stand chair test, physical activity level, symptoms, anxiety and depression symptoms, disease specific and generic quality of life. Primary endpoint is 10/12 weeks from baseline, while secondary endpoints are 22, 36, 62 weeks from baseline assessments.DISCUSSION: The study will likely contribute to knowledge regarding COPD tele-rehabilitation and to which extent it is more feasible and thereby more efficient than conventional COPD rehabilitation in patients with severe and very severe COPD.TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02667171 . Registration data: January 28th 2016.
AB - BACKGROUND: Rehabilitation of patients with chronic obstructive pulmonary disease (COPD) is a key treatment in COPD. However, despite the existing evidence and a strong recommendation from lung associations worldwide, 50% of patients with COPD decline to participate in COPD rehabilitation program and 30-50% drop-out before completion. The main reasons are severe symptoms, inflexible accessibility and necessity for transportation. Currently there are no well-established and evident rehabilitation alternatives. Supervised online screen rehabilitation could be a useful approach to increase accessibility and compliance. The aim of this multicenter RCT study is to compare the potential benefits of a 10-week online COPD rehabilitation program (CORe) with conventional outpatient COPD rehabilitation (CCRe).METHODS: This study is a randomized assessor- and statistician blinded superiority multicenter trial with two parallel groups, employing 1:1 allocation to the intervention and the comparison group.On the basis of a sample size calculation, 134 patients with severe or very severe COPD and eligible to conventional hospital based outpatient COPD rehabilitation will be included and randomized from eight different hospitals. The CORe intervention group receives group supervised resistance- and endurance training and patient education, 60 min, three times/week for 10 weeks at home via online-screen. The CCRe comparison group receives group based supervised resistance- and endurance training and patient education, 90 min, two times/week for 10 weeks (two hospitals) or 12 weeks (six hospitals) in groups at the local hospital. The primary outcome is change in the 6-min walking distance after 10/12 weeks; the secondary outcomes are changes in 30 s sit-to-stand chair test, physical activity level, symptoms, anxiety and depression symptoms, disease specific and generic quality of life. Primary endpoint is 10/12 weeks from baseline, while secondary endpoints are 22, 36, 62 weeks from baseline assessments.DISCUSSION: The study will likely contribute to knowledge regarding COPD tele-rehabilitation and to which extent it is more feasible and thereby more efficient than conventional COPD rehabilitation in patients with severe and very severe COPD.TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02667171 . Registration data: January 28th 2016.
U2 - 10.1186/s12890-017-0488-1
DO - 10.1186/s12890-017-0488-1
M3 - Journal article
C2 - 29145831
VL - 17
JO - B M C Pulmonary Medicine
JF - B M C Pulmonary Medicine
SN - 1471-2466
M1 - 140
ER -
ID: 194049299