Effectiveness of a Cardiac Rehabilitation Program in Elderly Patients With Heart Failure.

Summary

The main objective of the study is to assess the effectiveness of a cardiac rehabilitation program on functionality, measured by kinematic analysis, cardiorespiratory capacity, and ventricular ejection fraction in elderly patients with heart failure (HF). Other objectives will be; 1) to validate the kinematic analysis as an objective functional assessment that allows performing a functional stratification based on the severity of impairment ("kinematic phenotypes"), as well as to identify those patients who responders or are not responders to the cardiac rehabilitation program; 2) to develop a functional index that includes objective functional parameters, biomechanical biomarkers (heart and musculoskeletal echography) and physiological biomarkers (maximum consumption of oxygen (VO2 max), maximum heart rate (HR max) and blood lactate levels; 3) to analyse the degree of concordance of biomechanical biomarkers with functional tests normally used in clinical practice and with imaging and physiological biomarkers. A randomized, controlled, crossover clinical trial will be carried out at the Hospital Regional Universitario de Málaga. Clinically stable HF patients ≥70 years old will be included. The cardiac rehabilitation program will last 12 weeks and will follow the recommendations of the European Association of Cardiovascular Prevention and Rehabilitation. The patients will perform different functional tests, which will be at baseline, at 3 months and 6 months of follow-up.

Conditions

• Heart Failure With Preserved Ejection Fraction
• Sarcopenia
• Frail Elderly Syndrome
• Comorbidities and Coexisting Conditions

Interventions

PROCEDURE

Cardiac Rehabilitation Program (CR)

Strength exercises: strengthe exercise will be performed twice a week for 12 weeks, 4-6 series at 60% RM at the beginning of the program, with a progression towards 85% RM in each functional movement at the end of the intervention. The patients will rest for 90 seconds between series and 3 minutes between exercises. Each session has an estimated duration of between 45-60 min. Aerobic exercise: aerobic exercise it will be performed twice a week for twelve weeks, between 45-60 min each session of aerobic exercise. It will be developed on a treadmill or cycle ergometer at 50% of HR max at the beginning of the program with a progression towards 80% of HR max at the end, continuously or internally. The Borg scale will prevail over the objective data to adjust the intensity of each patient, Borg = 10/20 or mBorg = 5/10 at the beginning, with progression to Borg = 14/20 or mBorg = 8/10 at the end.

BEHAVIORAL

Control Group (CG)

The control group will receive two education sessions per week for twelve weeks on the complications derived from Heart Failure (HF), functional deterioration, and healthy lifestyle habits.

Sponsors & Collaborators

• University of Malaga

  lead OTHER

Principal Investigators

• Cuesta Vargas A Antonio Ignacio, PhD · University of Malaga

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-07

Primary Completion

2025-07-01

Completion

2025-07-01

Countries

• Spain

Study Locations