No phaseActive, not recruitingHealthspan endpoint
RE-inventing Strategies for Healthy Ageing; Recommendations and Tools (RESTART)
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
- Sponsor
- University of Tromso (Academic or other)
- Enrollment
- 119 enrolled
- Conditions
- Lifestyle, Healthy; Muscle Weakness; Abdominal Obesity; Cardiometabolic Syndrome; Self Efficacy; Diet, Healthy
- Interventions
- Complex lifestyle intervention; Physical activity monitoring and recommendations
- Ages
- adults, older adults
- Registry
- NCT06122441
Full record on ClinicalTrials.gov
From the registry
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…
Primary outcomes
- Change from baseline in VO2max at month 24
- Change from baseline in VO2max at month 12
- Change from baseline in VO2max at month 6
History
Study completion expected
Primary completion
Last registry update
Started
Registered