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ACTIVE NOT RECRUITING
NCT06122441
NA

RE-inventing Strategies for Healthy Ageing; Recommendations and Tools

Sponsor: University of Tromso

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

60 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

119

Start Date

2024-01-15

Completion Date

2027-06-30

Last Updated

2025-03-24

Healthy Volunteers

No

Interventions

BEHAVIORAL

Complex lifestyle intervention

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.

BEHAVIORAL

Physical activity monitoring and recommendations

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.

Locations (1)

UiT The Arctic University of Norway

Tromsø, Troms, Norway