Clinical trial

RE-inventing Strategies for Healthy Ageing; Recommendations and Tools

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06122441

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age60 Years to 75 Years

SexAll

Healthy volunteersNot accepted

ConditionLifestyle, Healthy, Muscle Weakness, Abdominal Obesity, Cardiometabolic Syndrome, Self Efficacy, Diet, Healthy

Full registry criteria

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 maintain a crouched position, unable to raise arms above shoulder or head height) * No possession of a smartphone * No access to the Norwegian national identification service (BankID) * Unable to follow the trial regimen for 24 months

Treatments and study arms

Complex lifestyle intervention

Behavioral

The complex lifestyle intervention comprise high-intensity aerobic and strength exercise, behavioral counselling based on Acceptance and Commitment Theory (ACT), and dietary counselling based on Norwegian nutritional guidelines. The different intervention elements are introduced step-wise to reduce initial overload. Participants are progressively transitioned over to the Tromsø municipality and local NGO's, who delivers activities harmonized with the intervention elements. Participants are at this stage also supported by an eTool which digitally reinforces the intervention through web-based information and videos.

Physical activity monitoring and recommendations

Behavioral

Wrist-worn activity trackers that are worn throughout the trial, which monitors steps, activity intensity and energy expenditure. Access to Norwegian physical activity guidelines via the Directorate of Health.

Primary outcomes

Change from baseline in VO2max at month 24Baseline and month 24

Assessed as ml/kg/min during an incremental test-to-exhaustion where the participant walks or runs on a motorized treadmill.

Change from baseline in VO2max at month 12Baseline and month 12

Assessed as ml/kg/min during an incremental test-to-exhaustion where the participant walks or runs on a motorized treadmill.

Change from baseline in VO2max at month 6Baseline and month 6

Assessed as ml/kg/min during an incremental test-to-exhaustion where the participant walks or runs on a motorized treadmill.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

UiT The Arctic University of Norway🇳🇴 Tromsø, Troms, Norway

Open map