RecruitingACTRN12615000519550

Effect of different Lifestyle Interventions on Vascular Risk factors and Arterial stiffness in Non-disabling Stroke and Transient Ischemic Attack (TIA) patients


Sponsor

Massey University

Enrollment

100 participants

Start Date

Aug 10, 2015

Study Type

Interventional

Conditions

Summary

Stroke is a leading cause of chronic disability in many developed countries, causing both physical and cognitive impairments. Research strongly suggests that exercise rehabilitation can help with these impairments. However, on closer inspection, it is evident that there is little clear consensus on what type of exercise (aerobic or resistance) results in attenuating vascular risk factors to the greatest degree. As such, there is limited evidence available to help guide best practice. In the acute and subacute phase of stroke care, getting the balance right between diagnosis, the start of therapies, medical interventions and exercise rehabilitation can be challenging. Improving our understanding of the impact of exercise and nutrition interventions on vascular and functional restoration should be a priority. The purpose of this research study is therefore to investigate the effect of aerobic exercise, resistance exercise, the combination and nutrition (following stroke diagnosis) on vascular risk factors and arterial stiffness in newly diagnosed non- disabling stroke and transient ischemic attack (TIA) patients. It is hypothesized that participation in a 12 week aerobic exercise program will Lead to significantly greater changes then: Resistance exercise alone Combination of resistance and aerobic exercise Usual care control group Nutrition group


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 85 Yearss

Plain Language Summary

Simplified for easier understanding

This study is investigating which type of exercise — aerobic (e.g., walking, cycling) or resistance (strength training), or a combination, or nutrition changes — is best at reducing the risk of another stroke or TIA (mini-stroke) in people who have recently had a non-disabling stroke or TIA. Researchers will track changes in blood vessel stiffness and other cardiovascular risk factors over 12 weeks. You may be eligible if: - You are between 18 and 85 years old - You have recently been diagnosed with a non-disabling stroke or TIA by a specialist - You are located within the Capital and Coast District Health Board (Wellington, New Zealand) You may NOT be eligible if: - You require supplemental oxygen - You have uncontrolled chest pain (angina) or an unstable heart condition - You have uncontrolled diabetes - You have a fever or active illness - You have leg pain when walking (claudication) - You have significant cognitive impairment - You are unable to walk or move independently Talk to your doctor about whether this trial might be right for you.

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Interventions

Baseline assessment - finger prick samples to measure blood profile markers. 12-lead ECG exercise stress test, to sub-maximal exhaustion (8mins) and images of the carotid artery via a pulsecor. Exe

Baseline assessment - finger prick samples to measure blood profile markers. 12-lead ECG exercise stress test, to sub-maximal exhaustion (8mins) and images of the carotid artery via a pulsecor. Exercise Intervention - 12 weeks, 40mins x 2 p/wk ARM 1 Aerobic - 40mins of aerobic exercise -Starting at 75% HRR with an increment of 10% every 4th week i.e. 75%, 85%. 95% HRR. Protocol = interval training – 1min exercise; 15secs rest. Completed on treadmill or stationery ergometer. ARM 2 Resistance - 40mins of circuit-resistance exercise – Starting at 75% HRR with an increment of 10% every 4th week i.e. 75%, 85%. 95% HRR. Protocol = interval training – 1min exercise; 15secs rest of 8 exercises (upper and lower body) x 4 sets ARM 3 12-weeks of Nutritional education and group sessions, 2 x 45-60mins p/wk, will be undertaken at Wellington Hospital or other identified location for cooking demonstrations by dieticians. The nutritional guidance will be based on a whole foods plant based diet. Patients will be educated on the benefits of such a diet in regards to vascular risk factor control and reversal of atherosclerosis. Continued sessions will also concentrate on how to achieve this type of diet through group sessions and cooking demonstrations Strategies to improve adherence: Exercising in a group setting Clinical Exercise Physiologists present at each exercise session to help monitor and ensure safety of participants


Locations(1)

Wellington, New Zealand

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ACTRN12615000519550


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