Exercise Intervention in Patients With Heart Failure With Preserved and Reduced Ejection Fraction

NCT05255172 | Enrolling By Invitation

• 1 other identifier: 2021-05044
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess by what physiological mechanisms patients with heart failure benefit from exercise. Effects of an exercise intervention will be assessed for both central (heart and lungs) and peripheral (muscle fiber and mitochondria) factors.

Conditions

Heart Failure New York Heart Association (NYHA) Class II; Heart Failure New York Heart Association (NYHA) Class III

Outcome Measures

Primary Outcomes (1)

• Maximal oxygen uptake (VO2peak)

  a change in maximal oxygen uptake (VO2 peak) of 2 ml/min/kg

  12 weeks intervention

Secondary Outcomes (4)

• Health related quality of life

  12 weeks intervention

• Cardiac volumes and function

  12 weeks intervention

• Perfusion gradients on Ventilation / Perfusion Single Photon Emission Computed Tomography (V/P SPECT)

  12 weeks intervention

• Mitochondrial function

  12 weeks intervention

Study Arms (2)

Supervised exercise

EXPERIMENTAL

The exercise intervention will include 2 supervised sessions of ergometer cycling with a warm up period of 10 minutes and 20 minutes of cycling at the aerobic intensity below the anaerobic threshold as determined from baseline results. Patients in the exercise arm will have 1 unsupervised exercise session where the participants walk or bicycle for 30 minutes at an intensity experienced as somewhat hard (Borg 13) according to the Borg Rating of Perceived Exertion Scale.

Other: Supervised Exercise

Standard of Care

NO INTERVENTION

The control group will receive advise to continue to live as usual. After 4 and 8 weeks, participants in the control group will be contacted by telephone for inquiry of general wellbeing. No other interventions will be performed in the control group.

Interventions

Supervised Exercise OTHER

12 weeks of supervised aerobic exercise individually adapted to exercise capacity according to a VO2 peak test

Supervised exercise

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signs and symptoms of heart failure
• Age ≥50 years
• Stable chronic heart failure (no hospitalizations within past month, no new medications past month)
• Able to understand and follow exercise prescription
• Currently physically inactive (less than 150 minutes/week moderate intensity exercise)

You may not qualify if:

• Currently or within the past 6 months been involved in cardiac rehab with exercise
• Devices or implants not compatible with magnetic resonance imaging or exercise testing
• Any orthopedic or medical condition affecting participation in testing and training
• Signs of acute ischemia during baseline cardiopulmonary exercise testing
• Participation in other clinical trials that may affect results
• Moderate or severe valvular disease
• Atrial fibrillation
• Moderate or severe chronic obstructive pulmonary disease
• NYHA class IV

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Skåne University Hospital Lund

Lund, 22158, Sweden

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 24, 2022
• Study Start: June 1, 2022
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)