- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01367197
Study of the Effect of Exercise Training on Patients in Atrial Fibrillation
Randomised Study of the Effect of Exercise Training on Patients in Atrial Fibrillation
PURPOSE Physical exercise is beneficial for patients with ischemic heart disease and chronic heart failure, while little is known about the effect in atrial fibrillation (AF). The investigators studied the effect of physical exercise on cardiac output (CO), max. exercise capacity, biomarkers and quality of life (Qol) in patients with AF in a randomised study of physical exercise training three times weekly for twelve weeks.
HYPOTHESIS Exercise training improves cardiac output (CO), max. exercise capacity, biomarkers and quality of life (Qol) in patients with AF.
METHODS Assessment of exercise capacity, CO, Qol, body composition, six minute walk test and muscular strength was performed before and after 12 weeks.
Resting echocardiography was done at baseline. CO was measured using impedance cardiography at rest and during maximal exercise testing on an ergometer bicycle. Body composition, muscular strength and six minutes walking capacity were measured before and after the training period. Qol was evaluated by the use of the standardized validated questionnaires Short Form 36 (SF-36) and the Minnesota Living with Heart Failure Questionnaire (MLHF-Q).
Training consisted of aerobic exercise at 70 percent of max. capacity estimated by Borg-scale.
Studieöversikt
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Hvidovre
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Copenhagen, Hvidovre, Danmark, 2650
- Hvidovre Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Adult subjects in permanent atrial fibrillation, willing to participate in a 12 weeks training program and able to give informed consent to participation were eligible for the study.
Exclusion Criteria:
- Subjects with severe refractory hypertension
- previous heart valve surgery, moderate to severe COPD
- restrictive lung disease, moderate to severe asthma
- pregnant or lactating subjects
- patients with a very low life expectancy
- patients who were unable to exercise or comply with the study protocol
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: No intervention
Observation only
|
|
|
Experimentell: Exercise training group
Group exercise training, three times weekly high-intensity
|
group based exercise training
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
cardiac output
Tidsram: participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
|
|
Quality of life
Tidsram: participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
|
|
exercise capacity
Tidsram: participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
muscle strength
Tidsram: participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
|
|
biomarkers ANB, BNP
Tidsram: participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
|
|
Body composition DEXA-scan
Tidsram: participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Philip S Osbak, MD, Hvidovre University Hospital
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 22300240
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