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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03443817 |
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Date of registration:
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19/02/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Feasibility and Effect of a Follow up Tele-rehabilitation Program for Chronic Obstructive Lung Disease vs. Standard Follow up
2-TELEKOL |
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Scientific title:
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Feasibility and Effect of a Follow up Tele-rehabilitation Program for Chronic Obstructive Lung Disease vs. Standard Follow up |
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Date of first enrolment:
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March 1, 2018 |
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Target sample size:
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54 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03443817 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Jose Cerdan |
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Address:
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Telephone:
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Email:
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Affiliation:
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Aarhus University Hospital |
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Name:
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Jose Cerdan, PhD stud |
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Address:
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Telephone:
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+4530648283 |
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Email:
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joscer@rm.dk |
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Affiliation:
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Name:
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Jose Cerdan, PhD student |
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Address:
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Telephone:
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30648283 |
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Email:
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joscer@rm.dk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Stable COPD
2. Signed informed consent
3. Completion of the standard rehabilitation program
4. Permanent oxygen therapy is not an obstacle for participation.
Exclusion Criteria:
1. The patient has significant musculoskeletal disorders that limit his / her function
levels to a degree that is not caused by dyspnea
2. The patient has pronounced dizziness, significant sensory or motor disability,
dementia or terminal malignant disease
3. Serious comorbidities (unstable heart disease, irregular diabetes, known malignant
disease, another disease that makes the patient unfit to participate in the study).
4. Non-compliant patient (eg. Nursing Homes Residents)
5. Participation in another project within the last 30 days
6. Mini-Mental State Examination score less than 24 points
7. Severe vision or hearing loss.
8. Non-Danish speaking.
9. Lack of will to implement the protocol.
10. Motor or sensory disease, which makes it impossible for walk training
11. Have experienced a worsening in the last 4-6 weeks
12. Musculoskeletal disorders
13. Serious heart diseases (ejection fraction <30%, daily angina, or as indicated by
treating the cardiologist)
14. Can not understand informed consent
15. Other factors that inhibit the use of telerehabilitation
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Disease, Chronic Obstructive
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Intervention(s)
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Behavioral: Tele rehab
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Primary Outcome(s)
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6 minute walk test
[Time Frame: measured at week 8]
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Secondary Outcome(s)
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health-related quality of life measured by SGRQ
[Time Frame: 6 months after cessation]
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6 minute walk test
[Time Frame: 6 months after cessation]
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Cost tele-rehab
[Time Frame: 6 months]
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Health-related quality of life
[Time Frame: 8 weeks, and 6 months after cessation]
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Generalised Anxiety Disorder Assessment (GAD-7)
[Time Frame: 8 weeks, and 6 months after cessation]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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