Exercise Training & Statins for Cardiovascular Health

NCT05474079 | Recruiting

• 1 other identifier: STA- 5035
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiovascular disease (CVD) refers to any condition that affects the heart and/or blood vessels (e.g. heart attack, stroke) and is the leading cause of death and disability worldwide. Regular exercise and statin therapy are widely recommended as frontline prevention strategies to reduce CVD risk. Recent changes to National Health Service (NHS) healthcare guidelines state that even individuals with a relatively low risk of CVD (≥10% risk score) should take a statin. When prescribed after a heart attack or stroke, both exercise and statins reduce the risk of a CVD-related death by \~25%, with some evidence to suggest that the combination of these therapies may offer additive cardiovascular protection. However, far less is known about the combined effects of exercise and statin therapy in primary CVD prevention (i.e. before a CVD event). Poor blood vessel function represents the earliest stage of CVD, which can be measured with ultrasound at different regions of the body (limbs, brain, heart) to sensitively detect early CVD risk. Regular exercise provides a variety of cardiovascular benefits and has a direct therapeutic effect on blood vessel function. In contrast, statin therapy primarily reduces CVD risk by lowering cholesterol, which may also improve blood vessel function. Although both therapies can separately reduce CVD risk, the interaction between exercise training and statin therapy on blood vessel function has never been directly compared in the setting of primary prevention, and it's currently unknown whether a combination of both therapies offers additional cardiovascular benefit. Therefore, the main aims of this study are to (i) investigate the effect of supervised exercise training on blood vessel function (limbs, brain, heart) in individuals with a CVD-risk score of ≥10% and (ii) examine whether these exercise effects differ in individuals taking a statin compared to those not taking a statin.

Conditions

Risk Reduction; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Change in Flow Mediated Dilatation (FMD)

  Brachial artery FMD, as a non-invasive measure of endothelial nitric oxide function, will be assessed using high resolution Duplex vascular ultrasonography in accordance with published guidelines.

  Pre and post intervention (12 weeks)

Secondary Outcomes (11)

• Change in sublingual glyceryl trinitrate (GTN) induced dilatation

  Pre and post intervention (12 weeks)

• Change in cold pressor induced dilatation

  Pre and post intervention (12 weeks)

• Change in arterial stiffness

  Pre and post intervention (12 weeks)

• Change in ultrasound assessment of cerebrovascular function- Assessment of cerebrovascular reactivity

  Pre and post intervention (12 weeks)

• Change in ultrasound assessment of cerebrovascular function -Dynamic cerebral autoregulation

  Pre and post intervention (12 weeks)

Other Outcomes (7)

• Change in 7-day physical activity monitoring: Intensity of activity

  Pre and post intervention (12 weeks)

• Change in 7-day physical activity monitoring: Frequency of activity

  Pre and post intervention (12 weeks)

• Change in 7-day physical activity monitoring: Duration of activity

  Pre and post intervention (12 weeks)

Study Arms (4)

Statin users exercise intervention

EXPERIMENTAL

The exercise training program will consist of individually tailored, progressive moderate-intensity aerobic exercise. Exercise training will comprise of a combination of treadmill, cross-trainer and cycle ergometer-based exercise. Exercise will progressively increase in both intensity and duration throughout the course of the intervention. Participants will begin the intervention with 30 minutes of moderate-intensity aerobic exercise at 40% heart rate reserve (HRR) three times per week for the initial 4 weeks. From week 4, exercise intensity will increase to 50% HRR, and at week 6 the duration of each session will increase to 45 minutes. From week 8, participants will exercise at an intensity of 60% HRR for 45 minutes, and from week 10, this will increase to five sessions per week.

Other: Moderate intensity exercise training

Statin users conventional care control

NO INTERVENTION

Participants randomized to the conventional primary care control group will not receive any supervision or guidance throughout the 12-week intervention beyond the initial standard healthcare advice provided by their general practitioner (GP).

Non-statin users exercise intervention

EXPERIMENTAL

The exercise training program will consist of individually tailored, progressive moderate-intensity aerobic exercise. Exercise training will comprise of a combination of treadmill, cross-trainer and cycle ergometer-based exercise. Exercise will progressively increase in both intensity and duration throughout the course of the intervention. Participants will begin the intervention with 30 minutes of moderate-intensity aerobic exercise at 40% HRR three times per week for the initial 4 weeks. From week 4, exercise intensity will increase to 50% HRR, and at week 6 the duration of each session will increase to 45 minutes. From week 8, participants will exercise at an intensity of 60% HRR for 45 minutes, and from week 10, this will increase to five sessions per week.

Other: Moderate intensity exercise training

Non-statin users conventional care control

NO INTERVENTION

Participants randomized to the conventional primary care control group will not receive any supervision or guidance throughout the 12-week intervention beyond the initial standard healthcare advice provided by their GP.

Interventions

Moderate intensity exercise training OTHER

The exercise training program will consist of individually tailored, progressive moderate-intensity aerobic exercise. Exercise training will comprise of a combination of treadmill, cross-trainer and cycle ergometer-based exercise. Exercise will progressively increase in both intensity and duration throughout the course of the intervention. Participants will begin the intervention with 30 minutes of moderate-intensity aerobic exercise at 40% HRR three times per week for the initial 4 weeks. From week 4, exercise intensity will increase to 50% HRR, and at week 6 the duration of each session will increase to 45 minutes. From week 8, participants will exercise at an intensity of 60% HRR for 45 minutes, and from week 10, this will increase to five sessions per week.

Non-statin users exercise intervention; Statin users exercise intervention

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Statin Users:
• Sedentary
• Non-smokers
• years old
• A 10-year CVD-risk score \> 10% (estimated via QRISK3)
• Weight stable (\<5% weight change over the last 3 months)
• Prescription of an 3-hydroxy-3-methylglutaryl coenzyme A reductase (HMG-CoA) inhibitor (statin) in stable dose for a minimum of 3 months and maximum of 3 years
• Non-Statin Users:
• Sedentary
• Non-smokers
• years old
• A 10-year CVD-risk score \> 10% (estimated via QRISK3)
• Weight stable (\<5% weight change over the last 3 months)

You may not qualify if:

• History or signs/symptoms of established cardiovascular, metabolic, renal or musculoskeletal disease
• Diagnosed with familial hyperlipidaemia and/or diabetes mellitus
• Stage 2 hypertension (≥160/100 mmHg)
• Any contraindications to exercise (e.g. unstable angina, severe orthopaedic conditions) and/or advised by GP not to undertake exercise
• BMI \>40kg/m2
• Current smoker or within 6 months of cessation
• Use of any medication other than statins (e.g., fibrates, metformin, thiazolidinediones, orlistat, anti-hypertensives) that could independently alter lipid metabolism and/or vascular function
• Post-menopausal female and using hormone replacement therapy, or pre-menopausal using oral contraceptives that independently alter lipid metabolism and/or vascular function

Sponsors & Collaborators

• Cardiff Metropolitan University: lead
• Health and Care Research Wales: collaborator

Study Sites (1)

Cardiff Metropolitan University

Cardiff, CF236XD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Risk Reduction Behavior; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Chris Pugh

  Cardiff Metropolitan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris Pugh

CONTACT

02920 205293; cjpugh@cardiffmet.ac.uk

Xela Dafauce Bouzo

CONTACT

07585476231; st20191506@outlook.cardiffmet.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: July 26, 2022
• Study Start: July 20, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)