Randomized clinical trial studying effects of a personalized supervised lifestyle intervention program on cardiovascular status in physically inactive healthy volunteers

Helena U Westergren, Li-Ming Gan, Marianne Månsson, Sara Svedlund, Helena U Westergren, Li-Ming Gan, Marianne Månsson, Sara Svedlund

Abstract

Background: The impact of personalized exercise training and a healthy dietary lifestyle in healthy volunteers on coronary flow reserve and cardiovascular function remains to be investigated in a controlled study setting.

Purpose: To examine the effects of a Mediterranean-inspired diet combined with regular physical exercise (standard) and a personalized supervised exercise program (DAPS) on coronary flow reserve and cardiovascular function.

Results: The number of males were 10 (59%) and 9 (47%) and mean age was 54 ± 12 and 55 ± 5 years in standard versus DAPS group, respectively. Primary outcomes were in addition to improved body composition and aerobic capacity, increased TDE-CFR (5.0%, CI:1.62,8.64, p = 0.005) and left ventricle ejection fraction (LVEF) during hyperemia (10.2%, CI:1.62,19.4, p = 0.022) in DAPS adjusted for the control period. Also, plasma fibrinogen decreased (-12.1%, CI:-22.0,-0.92, p = 0.035) in the DAPS group. Secondary outcomes, after adjusting DAPS intervention effects for the standard-training period, TDE-CFR and hyperemic LVEF remained significantly improved.

Materials and methods: This randomized, controlled clinical trial (URL: http://www.clinicaltrials.gov NCT02713724) included 36 healthy volunteers who underwent exercise ECG before randomization to standard or DAPS groups. Standard-group was given gym-membership with limited instructions and general dietary advice. DAPS-group received personalized supervised exercise programs and more detailed dietary advice with regular contact with a personal trainer. Effects were evaluated after 3 months. All participants underwent coronary flow reserve by transthoracic ultrasound (TDE-CFR), blood marker analysis and examinations of vascular function. Standard-group was evaluated pre-control, post-control (=pre-intervention) and post-intervention. DAPS-group was examined at pre-intervention and post-intervention.

Conclusions: A personalized supervised training- and diet program improves cardiovascular status in healthy subjects with a physically inactive lifestyle and may be a promising approach for cardiovascular prevention in the general population.

Keywords: coronary flow reserve; microvascular dysfunction; physical exercise; ultrasound.

Conflict of interest statement

CONFLICTS OF INTEREST Helena U Westergren and Li-ming Gan are currently employed by AstraZeneca R&D Gothenburg. At the time of study performance, Li-Ming Gan and Marianne Månsson were employed by AstraZeneca R&D Gothenburg. AstraZeneca did not have any additional role in the study design, data collection and analysis, or preparation of the manuscript. At the time of study performance Helena U Westergren and Sara Svedlund were supported by the Agreement concerning research and education of doctors (ALF/LUA grant), Swedish federal government. The decision to publish was made based on a consensus from all authors.

Figures

Figure 1. Recruitment and follow-up of study…
Figure 1. Recruitment and follow-up of study participants
CV=cardiovascular; DAPS=Diagnosis, Analysis, Personalization, Supervision.
Figure 2. Study design
Figure 2. Study design
Schematic overview of study design. Subjects were randomized into DAPS with a three months intervention period as well as a standard group including a three months control period followed by a three months standard exercise period. The primary objective of the current study was to compare effects of the DAPS program (A) including personalized exercise training and Mediterranean-inspired diet with a time-aligned initial control period of the standard group (B). Secondary objective was to compare the DAPS program (A) with the standard program (C), mimicking a regular gym and Mediterranean-inspired nutrition program. Finally, the third objective was to compare the standard program (C) with its own control period (B). DAPS = Diagnosis, Analysis, Personalization, Supervision.
Figure 3. Change in coronary flow reserve…
Figure 3. Change in coronary flow reserve and hyperemic left ventricle function after a personalized supervised health intervention program
The number of 36 healthy inactive volunteers were recruited for study participation and randomized into a three months DAPS program (n = 19) or a three months control period followed by three months standard intervention program (n = 17). (A) Shows the increase in CFR after DAPS intervention compared to controls, p = 0.005. (B) Displays the amelioration in hyperemic left ventricle ejection fraction in the DAPS group compared to controls, p = 0.022. Data are presented with mean ± SD. CFR = coronary flow reserve; DAPS = Diagnosis, Analysis, Personalization, Supervision; LVEF = Left Ventricle Ejection Fraction.

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