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

NCT05393362 | Completed DMC

• 1 other identifier: Funnel+ Study
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

Cardiovascular Rehabilitation; Physical functional performance; Kinematics; Structural; Physiological; Biomarkers; Functional tests; Heart failure

Outcome Measures

Primary Outcomes (3)

• Physiological biomarkers_Cardiopulmonary Exercise Testing (CPET)-(Peak VO2)

  Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: the maximum volume of oxygen intake \[VO2,(ml/kg/min)\]

  Baseline

• Physiological biomarkers_Cardiopulmonary Exercise Testing (CPET)-(Peak VO2)

  Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: the maximum volume of oxygen intake \[VO2,(ml/kg/min)\]

  Post intervention_difference (12 weeks after baseline)

• Physiological biomarkers_Cardiopulmonary Exercise Testing (CPET)-(Peak VO2)

  Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: the maximum volume of oxygen intake \[VO2,(ml/kg/min)\]

  Follow up (12 weeks after post-intervention)

Secondary Outcomes (92)

• Physiological biomarkers _Bioelectrical Impedance Analysis (BIA)- (PhA)

  Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)

• Physiological biomarkers _Bioelectrical Impedance Analysis (BIA)- (R)

  Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)

• Physiological biomarkers _Bioelectrical Impedance Analysis (BIA)- (Xc)

  Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)

• Physiological biomarkers _Bioelectrical Impedance Analysis (BIA)- (FFM)

  Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)

• Physiological biomarkers _Bioelectrical Impedance Analysis (BIA)- (FM)

  Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention)

Other Outcomes (12)

• Sociodemographic variables

  Baseline

• Anthropometric variables_ Height

  Baseline

• Anthropometric variables_ Weight

  Baseline

Study Arms (2)

Cardiac Rehabilitation Program (CR)

EXPERIMENTAL

The CR program will consist of aerobic exercise sessions and strength exercise sessions. The exercises will be individualized after assessing short effort capacities (strength exercise) and long efforts (aerobic exercise). It will be done four days a week, with a minimum of 48 hours between sessions of the same type of exercise. To make progress will be taking a clinical criterion into account, determined by the absence of symptoms derived from HF at the current intensity, and a temporary criterion where provided that the clinical criterion is met, the intensity will be increased every two-three weeks.

Procedure: Cardiac Rehabilitation Program (CR)

Control Group (CG)

ACTIVE COMPARATOR

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.

Behavioral: Control Group (CG)

Interventions

Cardiac Rehabilitation Program (CR) PROCEDURE

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.

Also known as: Exercise Group

Cardiac Rehabilitation Program (CR)

Control Group (CG) BEHAVIORAL

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.

Also known as: Health education group

Control Group (CG)

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Subjects older than 70 years.
• Subjects diagnosed with Heart Failure (HF) followed by the Heart Failure Unit.
• Subjects will be able or filling out questionnaires and perform functional tasks;
• Clinical stability.
• Patients receive optimal treatment.

You may not qualify if:

• Participants with cardiac pathologies that do not have an HF situation
• Score on the NYHA scale equal to 4.
• Hospitalization in a period of time equal to or less than 3 months.
• Score on the Mini-Mental scale (MMSE) below 24.
• Inability to get up from the chair at least 5 times
• Inability to walk.
• Inability to walk independently without a gait assist device (cane, crutch, or walker).
• Participation in an experimental study where they receive treatment.
• Inability to provide informed consent.

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

Antonio Cuesta Vargas

Málaga, Spain

Location

Related Publications (1)

• Cuesta-Vargas AI, Fuentes-Abolafio IJ, Garcia-Conejo C, Diaz-Balboa E, Trinidad-Fernandez M, Gutierrez-Sanchez D, Escriche-Escuder A, Cobos-Palacios L, Lopez-Sampalo A, Perez-Ruiz JM, Roldan-Jimenez C, Perez-Velasco MA, Mora-Robles J, Lopez-Carmona MD, Perez-Cruzado D, Martin-Martin J, Perez-Belmonte LM. Effectiveness of a cardiac rehabilitation program on biomechanical, imaging, and physiological biomarkers in elderly patients with heart failure with preserved ejection fraction (HFpEF): FUNNEL + study protocol. BMC Cardiovasc Disord. 2023 Nov 10;23(1):550. doi: 10.1186/s12872-023-03555-7.

  PMID: 37950216 DERIVED

MeSH Terms

Conditions

Sarcopenia; Heart Failure

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Cuesta Vargas A Antonio Ignacio, PhD

  University of Malaga

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The researchers who perform the assessments and analyzes of the data will be blinded.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD.Titular Doctor Physiotherapy Department,University of Malaga.Principal Investigator.

Model Details: Randomized crossover clinical trial at the Hospital Regional Universitario of Malaga

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 26, 2022
• Study Start: March 7, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: April 8, 2026

Record last verified: 2026-03

Locations

ES (1)