High Intensity Interval Training in the Treatment of Familial Hypercholesterolemia (UPPA-FH)

Condition(s) studied

Investigational drug(s) / intervention(s)

HIIT intervention program: The HIIT protocol will involve 3 training sessions per week for 16 weeks (a total of 48 sessions lasting 36 minutes). The program will be divided into two phases: phase 1 (adaptation to HIIT training: during the first 4 weeks, the intensity will be progressively increased to ensure the safety and progressive physical conditioning of the patients. The high-intensity intervals will follow the Norwegian 4 x 4-minute HIIT model: 4 bouts of 4 minutes of high intensity corresponding to a rating of perceived exertion (RPE) 15 to 18 on the Borg 6 to 20 Scale33 and an 85-95%HRmax, interspersed with 3-minute active recovery intervals (RPE of 11 to 13 and 54-69%HRmax). This protocol has been widely applied and is safe in general and in clinical populations. Additionally, this protocol includes the training parameters recently proposed in a recent meta-analysis to maximize the training effects of HIIT on cardiorespiratory fitness (primary outcome).

MICT intervention program: The MICT protocol will involve 3 training sessions per week for 16 weeks (a total of 48 sessions lasting 44 minutes). The workout will be performed at RPE 11 to 13 (54-69%HRmax) to provide an isoenergetic workload (same energy expenditure) as the HIIT group. Each session will include 3 parts: warm-up (5 min), main MICT workout (34 min), and a cool-down (5 min). Warm-up will include mobility, core, and aerobic exercise involving major muscle groups. The main workout (MICT) will include exercises involving major muscle groups using the same materials and rationale as commented on in the HIIT group. The cool-down phase will include aerobic exercise at a lower intensity, stretching, and relaxation exercises (RPE\<11). The highest and average HR and RPE for each session will be registered.

Study summary

This study has one main objective:

a) To assess the impact of two different supervised exercise interventions on cardiorespiratory fitness and markers of subclinical atherosclerosis in patients with Familiar Hipercolesterolemia (FH), and to unravel the underlying mechanisms behind these effects.

The starting hypothesis of the UPPA-FH project anticipates that both exercise interventions will produce a large increase in cardiorespiratory fitness and will improve significant markers of atherosclerosis in patients with FH, with high-intensity interval training program (HIIT) being more efficient than the moderate-intensity continuous training (MICT) modality. The main effects will be mediated by a significant change in the metabolomic signature of the participants. In addition, higher physical activity will be associated with more favorable markers of atherosclerosis progression, as shown through blood and image technique

Eligibility

Primary outcome measure(s)

• Cardiorespiratory fitness — Before and after the training intervention or control (16 weeks).
  Cardiorespiratory fitness will be assessed using the Bruce Protocol Ramp, a variation of the widely used Bruce Protocol. The test will be performed on a treadmill, with speed and incline progressively increasing every 15 seconds until exhaustion. Because CRF is the primary study outcome, maximal oxygen uptake will be continuously measured using the Vyntus CPT.

Trial sites (1)

More Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental trials in Spain