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 range60 Years – 75 Years

SexALL

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…

What they're measuring

Change from baseline in VO2max at month 24

Timeframe: Baseline and month 24

Change from baseline in VO2max at month 12

Timeframe: Baseline and month 12

Change from baseline in VO2max at month 6

Timeframe: Baseline and month 6

Trial details

NCT IDNCT06122441

SponsorUniversity of Tromso

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30