NCT04508478

Brief Summary

To test the impacts of different exercise training programs to the cardiopulmonary function, muscle metabolism, and body mass composition

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
8mo left

Started Nov 2021

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Nov 2021Dec 2026

First Submitted

Initial submission to the registry

August 9, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 3, 2021

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

3.2 years

First QC Date

August 9, 2020

Last Update Submit

August 14, 2025

Conditions

Keywords

Atrial Fibrillationweight trainingaerobic trainingcardio-pulmonary function

Outcome Measures

Primary Outcomes (3)

  • AF burden

    AF burden on 14 day ECG

    5 months

  • CPET/6 minute walking test

    CPET/6 minute walking test

    5 months

  • DEXA/muscle MRI

    DEXA/muscle MRI

    5 months

Study Arms (3)

Aerobic training

EXPERIMENTAL
Behavioral: Aerobic training

Resistance training

ACTIVE COMPARATOR
Behavioral: Resistance training

Control

PLACEBO COMPARATOR
Behavioral: Control physical exercise

Interventions

Aerobic training

Aerobic training

Resistance training

Resistance training

Control physical exercise

Control

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Paroxysmal or persistent atrial fibrillation
  • Daily activity below moderate intensity \< 300 minutes or high intensity \< 150 minutes per week.

You may not qualify if:

  • Active infection.
  • Implant cardiac pacemaker.
  • Uncontrolled hypertension.
  • Cardiopulmonary contraindication to exercise training, such as decompensated heart failure, acute pulmonary edema, unstable angina, uncontrolled arrhythmia causing hemodynamic compromise, symptomatic severe aortic stenosis, suspected dissecting aortic aneurysm, severe pulmonary hypertension, acute myocarditis, endocarditis or pericarditis, uncontrolled asthma and SpO2 \< 90% at rest on room air.
  • Inability to follow verbal command or to walk on treadmill or use stationary bike.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Chih-Chieh Yu, MD.PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2020

First Posted

August 11, 2020

Study Start

November 3, 2021

Primary Completion

December 31, 2024

Study Completion (Estimated)

December 31, 2026

Last Updated

August 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations