ClinicalTrials.Veeva

Menu

Atrial Fibrillation, Prevention and Rehabilitation

O

Odense University Hospital

Status

Completed

Conditions

Rehabilitation
Prevention
Atrial Fibrillation

Treatments

Behavioral: Complex prevention and rehabilitation intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT06337045
AF-rehab

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • the modified European Heart Rhythm Association (mEHRA) score ≥2B.

And at least one of the following risk factors:

  • Hypertension (treatment with >1 drug, diagnosis verified by home-blood pressure measurement, 24-hour ambulatory blood pressure measurement, or consultation blood pressure measurement >160/90mmHg).
  • Diabetes mellitus (HbA1c > 58mmol/mol unless higher values are accepted due to other aspects).
  • Obesity (Body Mass Index > 30).
  • Smoking (active smoker).
  • Alcohol consumption (> 7 units per week for women and > 14 units per week for men (according to the Danish Health Authority guidelines from 2019), or motivation for reduction).
  • Physical inactivity (less than the recommended 30 minutes per day).
  • Known sleep apnea or STOP-bang Sleep Apnea Questionnaire score >3).
  • Symptoms of anxiety or depression evaluated by the Hospital Anxiety and Depression Scale (HADS) > 7.
  • Mental vulnerability defined as self-evaluated burdened life with high perceived stress, small social network, and/or low educational level.

Exclusion criteria

  • ongoing treatment adjustments due to heart failure.
  • ongoing cardiac rehabilitation.
  • dementia, mental illness, language barrier or comorbidity that made it impossible to participate in this study.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Complex prevention and rehabilitation intervention (single arm)
Experimental group
Description:
It was a single-arm study.
Treatment:
Behavioral: Complex prevention and rehabilitation intervention

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems