RE-inventing Strategies for Healthy Ageing; Recommendations and Tools (NCT06122441) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
RE-inventing Strategies for Healthy Ageing; Recommendations and Tools
Norway119 participantsStarted 2024-01-15
Plain-language summary
The goal of the RESTART RCT is to examine whether a complex lifestyle intervention, coordinated with municipal and non-government organizations (NGO), can establish and preserve improvements in risk factors and functional capacity among older adults at high risk of cardiometabolic disease. The main objectives to investigate are whether a complex lifestyle intervention, compared to an active control group, will at 24 months have:
1. Produced a clinically relevant increase in cardiorespiratory fitness (primary endpoint)
2. Increased muscle strength, physical activity and reduced adiposity
3. Improved body composition, health-related quality of life and cognitive function
All participants (Control and Intervention Groups) are provided with wrist-worn activity trackers at baseline and access to national recommendations on physical activity. The intervention group additionally advances through a comprehensive lifestyle program including high-intensity aerobic and strength exercise, dietary and behavioral counselling. Intervention participants are gradually transitioned into exercise activities organized by Tromsø Municipaity and local NGO:s. Testing of outcomes are performed at baseline, 6, 12 and 24 months. Primary endpoint (VO2max) is assessed at 24 months.
Who can participate
Age range
60 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 60-75 years
* BMI ≥ 30 kg/m2
* Elevated CVD-risk (Score 8/12 on the NORRISK 2 model)
* Sedentary lifestyle (Score "1" on the Saltin-Grimby Physical Activity Level Scale)
Exclusion Criteria:
* Presence of dementia diagnosis
* Self-reported previous myocardial infarction or stroke, and/or self-reported established cardiovascular disease by presence of coronary stent
* Heart failure with ejection fraction \<50%
* Electrocardiogram ECG presenting with atrioventricular block grade 2 type 2 or grade 3, or previous myocardial infarction.
* Uncontrolled hypertension (systolic blood pressure≥180 mmHg and/or diastolic blood pressure≥110 mmHg unless cleared by a nephrologist)
* Chronic obstructive pulmonary disease grade 3 or 4
* Thyroid dysfunction (thyroxine \<7 pmol/L and thyroid-stimulating hormone \>10 mIU/L, and/or thyroxine \>25 pmol/L and thyroid-stimulating hormone \<0.2 mIU/L)
* Liver dysfunction (alanine aminotransferase \>210 µmol/L for men, \>135 µmol/L for women, and/or aspartate aminotransferase \>135 µmol/L for men, \>105 µmol/L for women, and/or alkaline phosphatase \>345 µmol/L)
* Kidney dysfunction (creatinine \>220 µmol/L), in addition to prognosis of CKD by GFR and Albuminuria KDIGO 2012 algorithm
* Severe anemia (hemoglobin \<10g/dL for men, \<8g/dL for women)
* Uncontrolled diabetes (glycated hemoglobin ≥86 mmol/mol)
* Severe hearing problems
* Severe mobility limitations (unable to get up from a sitting or lying position, unable to ma…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.