Status:
ACTIVE_NOT_RECRUITING
RE-inventing Strategies for Healthy Ageing; Recommendations and Tools
Lead Sponsor:
University of Tromso
Collaborating Sponsors:
The Research Council of Norway
Novo Nordisk A/S
Conditions:
Lifestyle, Healthy
Muscle Weakness
Eligibility:
All Genders
60-75 years
Phase:
NA
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 f...
Detailed Description
The proportion of older individuals worldwide is growing, posing a significant challenge to western societies. To address the health challenges of the aging population, primary prevention efforts shou...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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)
- Unable to follow the trial regimen for 24 months
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2027
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT06122441
Start Date
January 15 2024
End Date
June 30 2027
Last Update
March 24 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UiT The Arctic University of Norway
Tromsø, Troms, Norway, 9018