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RESTART
Sponsor study identifier
Secondary identifiers
NIH
interventional
119
1 country
1
Study Start
January 15, 2024
Actual (reported)Primary Completion
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 26, 2023
Actual (reported)November 8, 2023
Actual (reported)January 15, 2024
Actual (reported)June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change from baseline in VO2max at month 24
Assessed as ml/kg/min during an incremental test-to-exhaustion where the participant walks or runs on a motorized treadmill.
Baseline and month 24
Change from baseline in VO2max at month 12
Assessed as ml/kg/min during an incremental test-to-exhaustion where the participant walks or runs on a motorized treadmill.
Baseline and month 12
Change from baseline in VO2max at month 6
Assessed as ml/kg/min during an incremental test-to-exhaustion where the participant walks or runs on a motorized treadmill.
Baseline and month 6
Receives a complex lifestyle intervention, a wrist-worn activity tracker, and access to national recommendations on physical activity.
Receives a wrist-worn activity tracker and access to national recommendations on physical activity.
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.
UiT The Arctic University of Norway
Tromsø, Troms, 9018, Norway
Johansson J, Deraas TS, Hopstock LA, Henriksen A, Grimsgaard S. Improving and preserving cardiorespiratory fitness, muscle strength and adiposity through a complex lifestyle intervention in community-dwelling older adults with elevated cardiometabolic risk: study protocol for the RESTART randomised controlled trial. BMJ Open. 2025 Apr 19;15(4):e095810. doi: 10.1136/bmjopen-2024-095810.
Sameline Grimsgaard, PhD
UiT The Arctic University of Norway
Jonas Johansson, PhD
UiT The Arctic University of Norway
Trygve Deraas, PhD
UiT The Arctic University of Norway
Camilla Flåten, MSc
UiT The Arctic University of Norway
119 participants (actual enrollment reported by the registry).
First Submitted
October 26, 2023
First Posted
November 8, 2023
Change from baseline in muscle strength at month 24
Baseline and month 24
Change from baseline in muscle strength at month 12
Baseline and month 12
Change from baseline in muscle strength at month 6
Baseline and month 6
Change from baseline in muscle power at month 24
Baseline and month 24
Change from baseline in muscle power at month 12
Baseline and month 12
Change from baseline in relative body composition at month 24
Baseline and month 24
Change from baseline in relative body composition at month 12
Baseline and month 12
Change from baseline in absolute body composition at month 24
Baseline and month 24
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
André Henriksen, PhD
UiT The Arctic University of Norway
Laila Hopstock, PhD
UiT The Arctic University of Norway
Study Start
January 15, 2024
Actual (reported)Primary Completion
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 29, 2026
Record last verified: 2026-04
The principal investigators will have access to the final, complete trial dataset. Other investigators can apply to the steering committee for data and may receive access to data with variables specific to the research question of interest.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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