- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06122441
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
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:
- Produced a clinically relevant increase in cardiorespiratory fitness (primary endpoint)
- Increased muscle strength, physical activity and reduced adiposity
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
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 should focus on various lifestyle factors simultaneously. However, many interventions fail to maintain improved lifestyle habits among participants, highlighting the need for novel and complex approaches to ensure healthy aging among older adults.
The RESTART randomized controlled trial aims to investigate whether participants undergoing a complex lifestyle intervention improve their cardiorespiratory fitness, muscle strength, physical activity, adiposity and body composition, quality of life and cognitive function at 24 months, compared to active controls.
The study and data collection will occur in Tromsø, Norway (pop. 77,000). Participants will receive the intervention at a local community exercise center near the University of Tromsø campus area. Testing of physical performance will take place at the UiT Faculty of Health Sciences research laboratory for sports, physical activity, and public health. The Clinical Trial Unit (CTU) at the local university hospital will additionally oversee clinical examinations, collection of questionnaire data, and blood sampling.
At baseline, both the Control and Intervention Groups are given wrist-worn activity trackers and access to national physical activity recommendations. The Intervention Group also undergoes a comprehensive lifestyle program that includes high-intensity aerobic and strength exercises, as well as dietary and behavioral counseling. The Intervention Group is gradually introduced to exercise activities organized by Tromsø Municipality and local NGOs. Outcome testing is conducted at baseline, 6, 12, and 24 months, with the primary endpoint (VO2max) assessed at 24 months.
Intervention participants will be divided into 4 groups of 12-15 participants each and perform high-intensity training to target the cardiovascular system and skeletal muscle force-generating capacity. For 12 months, the intervention group performs supervised indoor cycling or outdoor hill interval training twice a week at a relatively high intensity (≥85% of maximal heart rate during 4x4 minutes) separated by active rest periods at approximately 70% of maximal heart rate. Immediately after the aerobic exercise, participants perform strength training (3 sets of 5 repetitions) involving leg-press, lateral pull-down, and chest press exercises, with an intensity corresponding to ≥80% of their maximal strength. From months 6-12, one of the two weekly exercise sessions will be led by the Healthy Life Center (HLC; "Frisklivssentralen"), enabling a transition to supervised exercise via the Tromsø municipality primary health care. Between month 12-18, the HLC continue to supervise the participants during one weekly exercise sessions, while they are additionally introduced to exercise activities arranged by local NGO:s.
From month 3 to 15, participants will receive behavioral counseling based on the Acceptance and Commitment Therapy (ACT) approach during six 2-hour group sessions. The individual approach aims to enhance participants' capacity to manage challenging cognitive and emotional experiences, foster psychological flexibility and distress tolerance skills, and promote the development of self-efficacy and new behavior patterns that align with their life values.
From month 6 to 15, the intervention group will receive four dietary counseling sessions based on Norwegian nutritional guidelines. Two individual sessions will involve food diaries, while two group sessions with a partner will focus on basic nutritional information and practical food preparation. The objective is to promote a healthy, sustainable, and personalized diet while promoting increased protein intake, reducing the consumption of high-energy-dense foods and drinks with low nutritional value.
Beginning from month 3 and onwards throughout the trial, the intervention group will be granted access to the Re-start eTool (https://re-start.no/), which is specifically tailored to older adults. The eTool offers concise and easy-to-understand articles, videos, and self-assessment tools that promote physical activity, healthy dietary habits, and behavioral strategies from the complex intervention. The Re-start eTool aims to provide support and reminders to participants as they gradually transition to independently maintaining the achieved lifestyle habits and physical capacity levels.
Throughout the study period, the intervention instructors and assessors monitor potential adverse events during the exercise and testing phases, and all adverse events are reported to the study coordinator. Measures to mitigate adverse events include: 1) insurance of participants via The Norwegian System of Patient Injury Compensation; 2) involving a MD with sports medicine specialization to ensure treatment of potential injuries; 3) pilot study experiences show that short-term alternative exercises are effective in managing exercise-induced pain and discomfort.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Troms
-
Tromsø, Troms, Norway, 9018
- UiT The Arctic University of Norway
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
- Existing diagnosis of dementia
- Previous stroke
- ECG showing previous myocardial infarction
- Uncontrolled hypertension (SBT>=220 mmHg or DBT>=120 mmHg)
- COPD grade 3 or 4
- Thyroid- liver- or kidney dysfunction
- Severe anemia
- Uncontrolled diabetes
- AV-block grade 2 or 3
- Atrial fibrillation or ventricula tachycardia
- Severe hearing problems
- Severe mobility limitations (unable to get up from a sitting or lying position, unable to maintain a crouched position, unable to maintain arms above shoulder or head height)
- No possession of a smartphone
- No access to the Norwegian national identification service (BankID)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Complex lifestyle intervention
Receives a complex lifestyle intervention, 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.
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 Comparator: Active control
Receives a wrist-worn activity tracker and access to national recommendations on physical activity.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in VO2max at month 24
Time Frame: Baseline and 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
Time Frame: Baseline and month 12
|
Previously described
|
Baseline and month 12
|
Change from baseline in VO2max at month 6
Time Frame: Baseline and month 6
|
Previously described
|
Baseline and month 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in muscle strength at month 24
Time Frame: Baseline and month 24
|
Assessed as the highest kg achieved during a 1-repetition maximum test in leg-press and chest-press apparatuses.
|
Baseline and month 24
|
Change from baseline in muscle strength at month 12
Time Frame: Baseline and month 12
|
Previously described
|
Baseline and month 12
|
Change from baseline in muscle strength at month 6
Time Frame: Baseline and month 6
|
Previously described
|
Baseline and month 6
|
Change from baseline in muscle power at month 24
Time Frame: Baseline and month 24
|
Assessed as power (W; force x speed of contraction) during leg-press exercise with pre-defined weight ascertained during baseline measurements
|
Baseline and month 24
|
Change from baseline in muscle power at month 12
Time Frame: Baseline and month 12
|
Previously described
|
Baseline and month 12
|
Change from baseline in muscle power at month 6
Time Frame: Baseline and month 6
|
Previously described
|
Baseline and month 6
|
Change from baseline in waist circumference at month 24
Time Frame: Baseline and month 24
|
Assessed in centimeters at the umbilical level (between crista iliaca and the lower rib) using a measurement tape.
|
Baseline and month 24
|
Change from baseline in waist circumference at month 12
Time Frame: Baseline and month 12
|
Previously described
|
Baseline and month 12
|
Change from baseline in waist circumference at month 6
Time Frame: Baseline and month 6
|
Previously described
|
Baseline and month 6
|
Change from baseline in minutes in moderate-to-vigorous physical activity per day at month 24
Time Frame: Baseline and month 24
|
Assessed as minutes in light, moderate and vigorous intensity, using triaxial accelerometers worn at the hip for 7 days.
|
Baseline and month 24
|
Change from baseline in minutes in moderate-to-vigorous physical activity per day at month 12
Time Frame: Baseline and month 12
|
Previously described
|
Baseline and month 12
|
Change from baseline in minutes in moderate-to-vigorous physical activity per day at month 6
Time Frame: Baseline and month 6
|
Previously described
|
Baseline and month 6
|
Daily physical activity pattern
Time Frame: 24 months
|
Asessed using wrist-worn smartwatches that are worn by the participants continously and measures steps, activity intensity and energy expenditure
|
24 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in relative body composition at month 24
Time Frame: Baseline and month 24
|
Assessed as percentage fat and lean mass in relation to total body mass using Dual-Energy X-ray Absorptiometry
|
Baseline and month 24
|
Change from baseline in relative body composition at month 12
Time Frame: Baseline and month 12
|
Previously described
|
Baseline and month 12
|
Change from baseline in absolute body composition at month 24
Time Frame: Baseline and month 24
|
Assessed as fat/lean/bone mass in grams using Dual-Energy X-ray Absorptiometry
|
Baseline and month 24
|
Change from baseline in absolute body composition at month 12
Time Frame: Baseline and month 12
|
Previously described
|
Baseline and month 12
|
Change from baseline in health-related quality of life at month 24
Time Frame: Baseline and month 24
|
Assessed with a 5-point likert scale in 5 different dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) using the EQ-5D-5L instrument
|
Baseline and month 24
|
Change from baseline in health-related quality of life at month 12
Time Frame: Baseline and month 12
|
Previously described
|
Baseline and month 12
|
Change from baseline in cognitive function using the Digit Symbol Substitution Test at month 24
Time Frame: Baseline and month 24
|
Assessed as the number of symbols correctly matched with numbers within the allowed time
|
Baseline and month 24
|
Change from baseline in cognitive function using the Digit Symbol Substitution Test at month 12
Time Frame: Baseline and month 12
|
Previously described
|
Baseline and month 12
|
Change from baseline in resting heart rate at month 24
Time Frame: Baseline and month 24
|
Assessed as beats per minute three times in 1-minute intervals after an initial 2-minute rest
|
Baseline and month 24
|
Change from baseline in resting heart rate at month 12
Time Frame: Baseline and month 12
|
Previously described
|
Baseline and month 12
|
Change from baseline in resting heart rate at month 6
Time Frame: Baseline and month 6
|
Previously described
|
Baseline and month 6
|
Change from baseline in systolic and diastolic blood pressure at month 24
Time Frame: Baseline and month 24
|
Assessed as mmHg three times in 1-minute intervals after an initial 2-minute rest
|
Baseline and month 24
|
Change from baseline in systolic and diastolic blood pressure at month 12
Time Frame: Baseline and month 12
|
Previously described
|
Baseline and month 12
|
Change from baseline in systolic and diastolic blood pressure at month 6
Time Frame: Baseline and month 6
|
Previously described
|
Baseline and month 6
|
Change from baseline in hand-held dynamometer-derived maximal handgrip strength at month 24
Time Frame: Baseline and month 24
|
Assessed in kg and performed according to the Southampton protocol
|
Baseline and month 24
|
Change from baseline in hand-held dynamometer-derived maximal handgrip strength at month 12
Time Frame: Baseline and month 12
|
Previously described
|
Baseline and month 12
|
Change from baseline in 5-repetition chair stand test performance at month 24
Time Frame: Baseline and month 24
|
Assessed as time (s) to complete 5 consecutive chair rises, using the 5-repetition chair stand test according to the Short Physical Performance Battery protocol
|
Baseline and month 24
|
Change from baseline in 5-repetition chair stand test performance at month 12
Time Frame: Baseline and month 12
|
Previously described
|
Baseline and month 12
|
Change from baseline in glycated hemoglobin (HbA1C) at month 24
Time Frame: Baseline and month 24
|
Assessed as % using non-fasted blood samples analysed with high-performance liquid chromatography
|
Baseline and month 24
|
Change from baseline in glycated hemoglobin (HbA1C) at month 12
Time Frame: Baseline and month 12
|
Previously described
|
Baseline and month 12
|
Change from baseline in glycated hemoglobin (HbA1C) at month 6
Time Frame: Baseline and month 6
|
Previously described
|
Baseline and month 6
|
Change from baseline in blood lipids (total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides) at month 24
Time Frame: Baseline and month 24
|
Assessed as mmol/l using non-fasted blood samples analysed with colorimetric (Homogen, or homogen enzymatic) methods
|
Baseline and month 24
|
Change from baseline in blood lipids (total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides) at month 12
Time Frame: Baseline and month 12
|
Previously described
|
Baseline and month 12
|
Change from baseline in blood lipids (total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides) at month 6
Time Frame: Baseline and month 6
|
Previously described
|
Baseline and month 6
|
Change from baseline in satisfaction with life at month 24
Time Frame: Baseline and month 24
|
Assessed with a 7-point likert scale using the 5-item Satisfaction With Life Scale (SWLS)
|
Baseline and month 24
|
Change from baseline in satisfaction with life at month 12
Time Frame: Baseline and month 12
|
Previously described
|
Baseline and month 12
|
Change from baseline in mental distress on the 5-item Hopkins Symptom Checklist (HSCL-5) at month 24
Time Frame: Baseline and month 24
|
Assessed with a 5-point likert scale using the 5-item Hopkins Symptom Checklist (HSCL-5)
|
Baseline and month 24
|
Change from baseline in mental distress on the 5-item Hopkins Symptom Checklist (HSCL-5) at month 12
Time Frame: Baseline and month 12
|
Previously described
|
Baseline and month 12
|
Change from baseline in physical activity discomfort and acceptance on the 10-item Physical Activity Acceptance Questionnaire (PAAQ) at month 24
Time Frame: Baseline and month 24
|
Assessed with a 7-point likert scale using the 10-item Physical Activity Acceptance Questionnaire (PAAQ)
|
Baseline and month 24
|
Change from baseline in physical activity discomfort and acceptance on the 10-item Physical Activity Acceptance Questionnaire (PAAQ) at month 12
Time Frame: Baseline and month 12
|
Previously described
|
Baseline and month 12
|
Change from baseline in physical activity enjoyment on the 4-item Physical Activity Enjoyment Scale Short Form (PACES-S) at month 24
Time Frame: Baseline and month 24
|
Assessed with a 4-point likert scale using the 4-item Physical Activity Enjoyment Scale Short Form (PACES-S)
|
Baseline and month 24
|
Change from baseline in physical activity enjoyment on the 4-item Physical Activity Enjoyment Scale Short Form (PACES-S) at month 12
Time Frame: Baseline and month 12
|
Previously described
|
Baseline and month 12
|
Change from baseline in emotional eating on the 3-item Emotional Eating Subscale from the Three-Factor Eating Questionnaire (TFEQ) at month 24
Time Frame: Baseline and month 24
|
Assessed with a 4-point likert scale using the 3-item Emotional Eating Subscale from the Three-Factor Eating Questionnaire (TFEQ)
|
Baseline and month 24
|
Change from baseline in emotional eating on the 3-item Emotional Eating Subscale from the Three-Factor Eating Questionnaire (TFEQ) at month 12
Time Frame: Baseline and month 12
|
Previously described
|
Baseline and month 12
|
Change from baseline in binge eating episodes on the Eating Disorder Examination (EDE) questionnaire at month 24
Time Frame: Baseline and month 24
|
Assessed with a 7-point likert scale using the item on binge eating episodes from the Eating Disorder Examination (EDE) questionnaire
|
Baseline and month 24
|
Change from baseline in binge eating episodes on the Eating Disorder Examination (EDE) questionnaire at month 12
Time Frame: Baseline and month 12
|
Previously described
|
Baseline and month 12
|
Change from baseline in intuitive eating on the 6-item Reliance on Internal Hunger and Satiety Cues Subscale from the Intuitive Eating Scale (IES) at month 24
Time Frame: Baseline and month 24
|
Assessed with a 5-point likert scale using the 6-item Reliance on Internal Hunger and Satiety Cues Subscale from the Intuitive Eating Scale (IES)
|
Baseline and month 24
|
Change from baseline in intuitive eating on the 6-item Reliance on Internal Hunger and Satiety Cues Subscale from the Intuitive Eating Scale (IES) at month 12
Time Frame: Baseline and month 12
|
Previously described
|
Baseline and month 12
|
Change from baseline in self-efficacy on the 10-item General Self-Efficacy Scale (GSE) at month 24
Time Frame: Baseline and month 24
|
Assessed with a 4-point likert scale using the 10-item General Self-Efficacy Scale (GSE)
|
Baseline and month 24
|
Change from baseline in self-efficacy on the 10-item General Self-Efficacy Scale (GSE) at month 12
Time Frame: Baseline and month 12
|
Previously described
|
Baseline and month 12
|
Number of participants with intervention-related adverse events
Time Frame: 24 months
|
Monitored consequently by intervention and outcome assessment personell
|
24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sameline Grimsgaard, PhD, UiT The Arctic University of Norway
- Study Director: 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
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Manifestations
- Insulin Resistance
- Hyperinsulinism
- Obesity
- Muscle Weakness
- Metabolic Syndrome
- Obesity, Abdominal
Other Study ID Numbers
- 2023/584841(REK)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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