NCT06122441Active, not recruiting

RE-inventing Strategies for Healthy Ageing; Recommendations and Tools

RE-inventing Strategies for Healthy Ageing; Recommendations and Tools (RESTART) - a Randomized Controlled Trial Testing a Complex Lifestyle Intervention in Older Adults at Increased Risk for Cardiometabolic Disease

Source: ClinicalTrials.gov · Last updated 29 Apr 2026

Brief summary (registry, in English)

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.

Status (registry): Active, not recruiting
Study type: Interventional
Enrollment: 119 (actual)
First submitted: 26 Oct 2023
Start date: 15 Jan 2024
Primary completion date: 30 Jun 2026
Lead sponsor: University of Tromso
Diseases: Obesity
NCT number: NCT06122441

What you commit to

Study type: Interventional
Participants enrolled: 119
From 15 Jan 2024 to the primary completion date, 30 Jun 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Self-reported previous myocardial infarction or stroke, and/or self-reported established cardiovascular disease by presence of coronary stent
Electrocardiogram ECG presenting with atrioventricular block grade 2 type 2 or grade 3, or previous myocardial infarction.

Other illness

Presence of dementia diagnosis
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

Lab values

Heart failure with ejection fraction \<50%
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)

Other

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)
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

Who the study is looking for

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)

Age in the registry: 60 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Uit The Arctic University of Norway Coordinator of this site? Confirm its status	Tromsø	Norway	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.