Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance

Last updated on July 2021

Recruitment

Recruitment Status: Recruiting
Estimated Enrollment: Same as current

Summary

Conditions

Exercise Intolerance
Heart Failure
Peripheral Artery Disease
Sarcopenia

Type

Interventional

Phase

Not Applicable

Design

Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a single-blinded, randomized controlled longitudinal study design to determine if NMES will increase muscle mass and strength and improve exercise capacity thus improving likelihood of engagement with a structured exercise program. Patients will be randomized to either intervention that includes NMES or to a sham control group. In order to ensure that the two groups are comparable between treatment and sham interventions, the participants will be randomized according to gender. Randomization via minimization will be used in order to avoid an unbalanced number of women in the two comparison groups due to chance. A file of the computer-generated random assignments will be kept.Masking: Single (Outcomes Assessor)Masking Description: The Investigator will collect baseline data before the participant is randomized. The intervention/sham will be set-up by the Investigator. The Investigator who is trained in both NMES and Sham intervention will then look at the randomization schedule and set up and train the participants on equipment usePrimary Purpose: Treatment

Participation Requirements

Age: Between 18 years and 79 years
Gender: Both males and females

Description

Not Provided

Tracking Information

NCT #: NCT04545268
Collaborators: Not Provided
Investigators: Principal Investigator: Andrey V Bezdenezhnykh, PhD Research Institute for Complex Issues of Cardiovacular Diseases