Health TrialsbyHealthPanel

Reducing Heart Failure Risk in Late-Life With Physical Activity

ConditionsHypertensionExercise TrainingCardiac RehabilitationProteomics
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorBrigham and Women's Hospital

About this trial

The goal of this clinical trial is to learn about the molecular pathways associated with the benefit of a regular exercise program in patients with high blood pressure and who don't already participate in regular exercise.

The main question it aims to answer is to identify protein signatures associated with the benefits of a cardiac rehabilitation exercise program.

The trial will enroll 42 participants, who will be randomized to a 12 week cardiac rehabilitation exercise program versus control arm and asked to participate in the following at the beginning and end of study:

* Cardiopulmonary exercise test (CPET) * Echocardiogram * Physical function test * 6-minute walk test * Hand grip strength * Quality of life questionnaire * Blood draws

Researchers will compare results between those who do and don't participate in the exercise program.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Hypertension (controlled on stable medication regimen)

Structural heart abnormality (LVH or LA enlargement)

LVEF > 50%

Sedentary

Disqualifiers

Diabetes

Unable to exercise

Supplemental oxygen use

Pulmonary hypertension

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cardiac Rehabilitation

    Behavioral

    Participation in a 12-week cardiac rehabilitation program

  • Attention Control

    Behavioral

    Participants will receive regular phone calls in place of cardiac rehabilitation visits

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Cardiac RehabilitationExperimental treatment 1 intervention
Group B: Attention ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Impact of Cardiac Rehabilitation training on single protein changes

Change in protein levels assessed by blood draws and measured by Somascan assay. ANCOVA analysis adjusting for baseline protein levels with intention to treat group assignment

Time frame
12 weeks

Secondary outcomes

1

Correlation of change in proteins with change in VO2 max

Correlation of single protein changes associated with change in VO2 max

Time frame
12 weeks
2

Correlation of change in proteins with change in LV global longitudinal strain

Correlation of single protein changes associated with change in LV global longitudinal strain

Time frame
12 weeks
3

Correlation of change in proteins with change in LV diastolic function

Correlation of single protein changes associated with change in LV diastolic function

Time frame
12 weeks
4

Correlation of change in proteins with change in VE/VCO2

Correlation of single protein changes associated with change in VE/VCO2

Time frame
12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: