The Effects of Supervised Exercise Training in the Primary Prevention of Cardiovascular Disease in Stain-Users and Non Statin-Users

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 65
Healthy Volunteers: t
View:

⁃ Statin Users:

• Sedentary

• Non-smokers

• 50-65 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

• 50-65 years old

• A 10-year CVD-risk score \> 10% (estimated via QRISK3)

• Weight stable (\<5% weight change over the last 3 months)

Locations
Other Locations
United Kingdom
Cardiff Metropolitan University
RECRUITING
Cardiff
Contact Information
Primary
Chris Pugh
cjpugh@cardiffmet.ac.uk
02920 205293
Backup
Xela Dafauce Bouzo
st20191506@outlook.cardiffmet.ac.uk
07585476231
Time Frame
Start Date: 2022-07-20
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 80
Treatments
Experimental: Statin users exercise intervention
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.
No_intervention: Statin users conventional care control
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).
Experimental: Non-statin users exercise intervention
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.
No_intervention: Non-statin users conventional care control
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.
Related Therapeutic Areas
Sponsors
Leads: Cardiff Metropolitan University
Collaborators: Health and Care Research Wales

This content was sourced from clinicaltrials.gov