NCT03335319

The Effect Of An Expanded Long Term Periodization Exercise Training In Patients With Cardiovascular Disease

Completed NA Last updated 25 March 2020

What this trial tests

NA trial testing Periodized Exercise Training Regime in Cardiovascular Diseases in 50 participants. Completed in 20 December 2019.

Timeline

1 October 2017

Primary endpoint
20 December 2019

20 December 2019

Quick facts

Lead sponsor	University of Lisbon
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	50
Start date	1 October 2017
Primary completion	20 December 2019
Estimated completion	20 December 2019
Sites	1 location across Portugal

Drugs / interventions tested

• Periodized Exercise Training Regime
• Non Periodized Exercise Training Regime

Conditions studied

• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
• Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

University of Lisbon

Who can join

18 and older, any sex, with Cardiovascular Diseases or Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Benefits from cardiac rehabilitation (CR) programs are evidence based and widely recognized. Less than 50% of people who participate in hospital-based CR programs maintain an exercise regimen for as long as six months after completion. Despite the benefits associated with regular exercise training (ET), adherence with supervised exercise-based CR remains low.

Current exercise guidelines for CR focus on moderate intensity steady state exercises, with walking and cycling being the most recommended types of ET. The repetitive nature of this type of activity can become monotonous for the patient, affecting exercise adherence, compliance and training outcomes. Exercise periodization is a method typically used in sports training, but the impact of periodized exercise to yield optimal beneficial effects in cardiac patients is still unclear.

In healthy or trained populations, periodization aims to optimize ET adaptations as compared with non periodized training, to prevent overtraining and to avoid plateauing of training adaptations. Periodized methods are considered to be superior to non periodized methods in trained populations and appears to be superior in inactive adults. In most of the CR programs there are no periodization or exercise progression during medium to long term interventions. Further randomized controlled trials (RCT) are necessary to evaluate long-term periodization outcomes.

The purpose of this research project is twofold:

1. To conduct a 12-month randomized control trial to evaluate the effects of a periodized ET regime versus a non periodized ET regime (guidelines) on VO2 peak, maximal strength, body composition, functionality and quality of life in cardiovascular disease patients.
2. to differentiate the effects of a 12-month periodized ET regime versus a non periodized ET regime on the different components of the oxygen kinetics response and oxidative adaptations in cardiovascular disease patients.

These patients will be randomized in 2 ET groups: 1) periodization; 2) non periodization. This experimental design will occur during 48 weeks 3 times per week with 4 assessment time points: M0) before starting the ET program (baseline); M1) 3 months after starting the ET; M2) 6 months after starting the ET program and M3) 12 months at the end of the community-based ET program.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The effect of an expanded long-term periodization exercise training on physical fitness in patients with coronary artery disease: study protocol for a randomized controlled trial.
   Pinto R, Angarten V, Santos V, Melo X, et al · · 2019 · cited 11× · PMID 30975195 · DOI 10.1186/s13063-019-3292-9