NCT06337045

Atrial Fibrillation, Prevention and Rehabilitation

Completed NA Last updated 29 March 2024

What this trial tests

NA trial testing Complex prevention and rehabilitation intervention in Atrial Fibrillation in 50 participants. Completed in 30 June 2020.

Timeline

1 February 2019

Primary endpoint
30 June 2020

30 June 2020

Quick facts

Lead sponsor	Odense University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	50
Start date	1 February 2019
Primary completion	30 June 2020
Estimated completion	30 June 2020
Sites	2 locations across Denmark

Drugs / interventions tested

• Complex prevention and rehabilitation intervention

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →
• Prevention — all drugs for Prevention →
• Rehabilitation — all drugs for Rehabilitation →

Sponsor

Odense University Hospital

Who can join

18 and older, any sex, with Atrial Fibrillation or Prevention. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Evidence shows that people with atrial fibrillation (AF) can benefit from prevention and rehabilitation interventions related to quality of life, lowered anxiety, etc. In this study, a complex prevention and rehabilitation intervention for people with AF was carried out in a Health Center at a Danish municipality in cooperation with the cardiology department at Svendborg Hospital. The study was designed as a feasibility study, with data gathered systematically including focus group interviews and quantitative patient reported outcomes. People with AF were included at the hospital. Eligible participants were offered intervention in the Health Center. Interventions, in accordance with present international guidelines, consisted of physical exercise, patient education, psychosocial support and consultations with health professionals as well as risk factor management. Also, medicinal yoga (MediYoga) were chosen to be part of the intervention due to promising research results within AF. All interventions were optional and based on needs assessment and preferences.

The primary objective was to investigate the feasibility of delivering a complex prevention and rehabilitation intervention for people with AF in a municipal Health Center.

There were the following four secondary objectives:

1. To explore the participant's experiences of participating in the municipality-based complex prevention and rehabilitation intervention.
2. To explore the participant's needs and preferences of the interventions.
3. To explore changes in HRQoL, anxiety and depression.
4. To explore the feasibility of collecting patient reported outcome measures as part of the intervention.

The hypothesis was that the complex prevention and rehabilitation intervention was feasible in a municipality-based set-up, and was well received by people with AF and may contribute to better outcomes in terms of HRQoL, anxiety and depression.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Atrial fibrillation and primary care prevention and rehabilitation - a feasibility study.
   Elnegaard CM, Pedersen MK, Zwisler AO, Borregaard B, et al · · 2025 · PMID 41299666 · DOI 10.1186/s40814-025-01724-3