Health TrialsbyHealthPanel

Exercise Intensity and Muscle Recovery in Statin Users

ConditionStatin Adverse Reaction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-65
SponsorRaffaele Mazzolari

About this trial

This study aims to investigate how different types and intensities of exercise affect muscle recovery in individuals taking statin medications compared to healthy controls. Statins are essential for cardiovascular prevention but are often associated with muscle-related side effects (SAMS), which can be exacerbated by physical activity.

The study will compare aerobic cycling (low muscular strain) with resistance training (RT) at increasing intensities (40%, 60%, and 80% of estimated 1-repetition maximum; e1RM). Researchers will measure markers of muscle damage, such as creatine kinase (CK) levels, and subjective recovery needs to determine which exercise modalities and intensities are best tolerated by statin users. The goal is to provide evidence for more individualized and safer exercise recommendations for this population.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Sedentary behavior (defined as < 1 hour of planned physical activity per week)

Low occupational physical activity

Age between 30 and 65 years

Non-smoker

Disqualifiers

BMI < 20 kg/m² or > 30 kg/m²

Smoking or smoking cessation < 1 year ago

Medical conditions or musculoskeletal issues that preclude eligibility for full physical effort or interfere with outcome measures

Medication (other than statins) that may interfere with physical exercise or outcome measures (assessment on a case-by-case basis during screening visit)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dose-Escalation Exercise Protocol

    Other intervention

    A dose-escalation protocol consisting of END (40 minutes of cycling at 60% HRR) and RT at 40%, 60%, and 80% of e1RM. RT includes 8 machine-based exercises, 2 sets per exercise, with repetitions decreasing as intensity increases (20, 12, and 8 reps respectively). Each intensity period comprises two identical sessions with a 5-21 day washout. All sessions are supervised.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Statin-users (STN)Experimental treatment 1 intervention
Group B: Statin-naïve controls (CON)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in serum creatine kinase (CK) level from pre-exercise to 24 hours post-exercise

Serum CK will be measured from capillary blood samples drawn from the earlobe. The outcome measure is the calculated change from the pre-exercise baseline value to the value obtained 24 hours after each exercise session.

Time frame
Baseline and 24 hours post-exercise

Secondary outcomes

1

Change in pressure pain threshold (PPT) from pre-exercise to 24 hours post-exercise

PPT will be measured using a handheld algometer with a 1-cm² probe on the rectus femoris. The outcome is the change from the pre-exercise baseline value to the value obtained 24 hours after each exercise session.

Time frame
Baseline and 24 hours post-exercise
2

Heart rate (HR) during exercise

HR will be measured continuously in beats per minute during the entire exercise session. The outcome measure will be the average heart rate sustained over the duration of the session.

Time frame
Continuous during each exercise session (from the start to the end of each endurance and resistance training session).
3

Blood lactate concentration before and after exercise

Blood lactate concentration will be measured from capillary blood samples drawn from the earlobe before and after each exercise session. The outcome is the change from the pre-exercise baseline value to the value obtained immediately after each exercise session.

Time frame
Before the start and immediately after each endurance and resistance training session.
4

Subjective Need for Recovery after exercise (questionnaire)

Subjective sensation of the need for recovery will be quantified using a validated questionnaire. The specific questionnaire and its scoring range (minimum and maximum values) will be entered in the results reporting phase. Higher scores indicate a greater need for recovery.

Time frame
Questionnaires will be collected daily to enable intra-individual robust scaling. However, the analysis will focus on recovery needs 24 hours post-exercise.

Other outcomes

Sponsors and contacts

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

Raffaele Mazzolari

Lead sponsor

Medical University Innsbruck

Sponsor institution

Universitaet Innsbruck

Collaborator

Source ClinicalTrials.gov
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