Effect of Resistance Training in Patients on the Waiting List for Heart Transplant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Sao Paulo General Hospital
About this trial
The present longitudinal, randomized, and blinded clinical trial aims to:
* Evaluate the effects of resistance training on the functional capacity, quality of life, and cardiac biomarkers of hospitalized patients with heart failure (HF) on the waiting list for heart transplantation (HTx). * Evaluate the associations between Fried's frailty classification and functional capacity responses to resistance training.
The protocol will have a total duration of 12 weeks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients included in heart transplant list ≤1 month
hemodynamically stable in the last 48 hours defined as mean arterial pressure (MAP) ≥ 60 mmHg and ≤ 120 mmHg and - Heart rate (HR) ≥ 60 bpm and ≤ 120 mmHg.
dobutamine dose ≤ 10 mcg/kg/min
Disqualifiers
heart failure of arrhythmogenic and/or restrictive etiology
presence of uncontrolled acute arrhythmias
cognitive, orthopedic, or neuromotor changes that prevent functional tests from being carried out
Trial design
Design model
Parallel
Treatments tested in this trial
Resistance Training Program
Other interventionThe resistance training program will be individualized and divided into four stages of increasing complexity. It will be conducted for approximately 40 minutes per day, three times a week, for 12 weeks, under supervision. Each patient will begin the program at the stage corresponding to their functional capacity. The resistance load will be set at 50% of the maximum resistance (1RM) obtained in the initial assessment. Throughout all stages of the exercise program, the target intensity will range from light (≤ 12) to moderate (≤ 15) on the Borg scale.
Standard Treatment Group
Other interventionPatients will receive the standard treatment provided by the hospital inpatient unit, which includes guidance on reducing sedentary time, encouragement to walk, and performance of active and breathing exercises when necessary.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Resistance Training GroupExperimental treatment 2 interventions
Group B: Standard Treatment GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
To investigate changes in physical performance measured by Six-Minute Walk Test.
Measures: the assessment will take place in a flat 30-meter corridor, marked every 1 meter with non-slip flooring, and the patient will be instructed to walk for six minutes as fast as possible.
Time frame
The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).2
To investigate changes in physical performance measured by Short Physical Performance Battery (SPPB).
The SPPB consists of three additional tests assessing balance, mobility, and strength. Each test is scored from 0 (indicating a worse outcome) to 4 (indicating a better outcome) points. At the completion of all tests, the total score ranges from 0 to 12 points.
Time frame
The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).3
To investigate changes in respiratory muscle strength:
Maximum inspiratory pressure (measured in cmH2O)
Time frame
The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).4
To investigate changes in peripheral muscle strength.
Handgrip test (measured in KgF)
Time frame
The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).Secondary outcomes
1
To investigate changes Fried's frailty phenotype
The Fried's frailty phenotype scale ranges from 0 to 5 points, where: 0 points denote non-frailty, up to 2 points denote pre-frailty, and ≥3 points denote frailty
Time frame
The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2).2
To investigate changes in heart rate( bpm)
Time frame
Immediately before and after each session exercise training.(3 times per week, during 12 weeks)3
To investigate changes in blood pressure (mmHg)
Time frame
Immediately before and after each session exercise training (3 times per week, during 12 weeks)4
To investigate changes in perceived exertion sensation:
Borg Rating of Perceived Exertion (0-lower, up to 10- highest)
Time frame
Immediately before and after each session exercise training.(3 times per week, during 12 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Sao Paulo General Hospital
Lead sponsor
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Collaborator
Source ClinicalTrials.gov