RE-inventing Strategies for Healthy Ageing; Recommendations and Tools

NCT06122441 | Active Not Recruiting

• 1 other identifier: 2023/584841(REK)
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief 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. 1.Produced a clinically relevant increase in cardiorespiratory fitness (primary endpoint)
2. 2.Increased muscle strength, physical activity and reduced adiposity
3. 3.Improved body composition, health-related quality of life and cognitive function

Conditions

Cardiometabolic Syndrome; Self Efficacy; Abdominal Obesity; Diet, Healthy; Lifestyle, Healthy; Muscle Weakness

Keywords

Complex lifestyle intervention; Older adults; Cardiometabolic risk factors; Cardiorespiratory fitness; Muscle strength; Physical activity; Abdominal obesity; Acceptance and commitment therapy; Health-related quality of life; Cognitive function

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (16)

• 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

Other Outcomes (94)

• 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

Study Arms (2)

Complex lifestyle intervention

EXPERIMENTAL

Receives a complex lifestyle intervention, a wrist-worn activity tracker, and access to national recommendations on physical activity.

Behavioral: Complex lifestyle intervention; Behavioral: Physical activity monitoring and recommendations

Active control

ACTIVE COMPARATOR

Receives a wrist-worn activity tracker and access to national recommendations on physical activity.

Behavioral: Physical activity monitoring and recommendations

Interventions

Complex lifestyle intervention BEHAVIORAL

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.

Complex lifestyle intervention

Physical activity monitoring and recommendations BEHAVIORAL

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.

Active control; Complex lifestyle intervention

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Presence of dementia diagnosis
• Self-reported previous myocardial infarction or stroke, and/or self-reported established cardiovascular disease by presence of coronary stent
• Heart failure with ejection fraction \<50%
• Electrocardiogram ECG presenting with atrioventricular block grade 2 type 2 or grade 3, or previous myocardial infarction.
• 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
• 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)
• 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)
• 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)

Sponsors & Collaborators

• University of Tromso: lead
• The Research Council of Norway: collaborator
• Novo Nordisk A/S: collaborator
• Tromso Municipality: collaborator
• University Hospital of North Norway: collaborator
• University of Oslo: collaborator
• Molde University College: collaborator
• National Association for Heart and Lung Diseases, Tromso, Norway: collaborator
• Norwegian Trekking Association: collaborator
• KRAFT Sports Center: collaborator

Study Sites (1)

UiT The Arctic University of Norway

Tromsø, Troms, 9018, Norway

Location

Related Publications (1)

• 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.

  PMID: 40254301 DERIVED

Related Links

• Project webpage (only currently available in Norwegian)

MeSH Terms

Conditions

Muscle Weakness; Obesity, Abdominal; Metabolic Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Behavior

Study Officials

• Sameline Grimsgaard, PhD

  UiT The Arctic University of Norway

  PRINCIPAL INVESTIGATOR

• Jonas Johansson, PhD

  UiT The Arctic University of Norway

  STUDY DIRECTOR

• Trygve Deraas, PhD

  UiT The Arctic University of Norway

  STUDY DIRECTOR

• Camilla Flåten, MSc

  UiT The Arctic University of Norway

  STUDY DIRECTOR

• André Henriksen, PhD

  UiT The Arctic University of Norway

  STUDY DIRECTOR

• Laila Hopstock, PhD

  UiT The Arctic University of Norway

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and data analysts will be blinded to group assignment from baseline to primary endpoint assessment. It is not possible to blind the participants or intervention staff due to the nature of the intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RESTART is designed as a two-arm, single blind, parallel group RCT, with a 1:1 allocation ratio into either intervention or active control group

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 8, 2023
• Study Start: January 15, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: From January 2027 until December 2030. A possible extension to 2035 is planned to be applied for from the regional ethics committee
• Access Criteria: Anonymous datasets are shared directly via study coordinator. Unidentified datasets (containing potential reverse-identifiable data) are accessed via the Norwegian Services for Sensitive Data server.

Locations

NO (1)