RE-inventing Strategies for Healthy Ageing; Recommendations and Tools

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.

NCT Number	NCT06122441
Lead Sponsor	University of Tromso Collaborators: The Research Council of Norway, Novo Nordisk A/S, Tromso Municipality, University Hospital of North Norway, University of Oslo, Molde University College, National Association for Heart and Lung Diseases, Tromso, Norway, Norwegian Trekking Association, KRAFT Sports Center
Conditions	Lifestyle, Healthy, Muscle Weakness, Abdominal Obesity, Cardiometabolic Syndrome, Self Efficacy, Diet, Healthy
Enrollment	119 participants
Start Date	2024-01-15
Primary Completion	2026-06-30 (estimated)
Study Completion	2027-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-04-29