RE-inventing Strategies for Healthy Ageing; Recommendations and Tools

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

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

Intervention / Treatment
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* Behavioral: Complex lifestyle intervention
* Behavioral: Physical activity monitoring and recommendations


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Complex lifestyle intervention<br>Receives a complex lifestyle intervention, a wrist-worn activity tracker, and access to national recommendations on physical activity. | Behavioral: Complex lifestyle intervention<br>* 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.<br>Behavioral: Physical activity monitoring and recommendations<br>* 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.<br>|
| Active Comparator: Active control<br>Receives a wrist-worn activity tracker and access to national recommendations on physical activity. | Behavioral: Physical activity monitoring and recommendations<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Previously described | Baseline and month 12 | 
| Change from baseline in VO2max at 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 | 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 | Previously described | Baseline and month 12 | 
| Change from baseline in muscle strength at month 6 | Previously described | Baseline and month 6 | 
| Change from baseline in muscle power at 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 | Previously described | Baseline and month 12 | 
| Change from baseline in muscle power at month 6 | Previously described | Baseline and month 6 | 
| Change from baseline in waist circumference at 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 | Previously described | Baseline and month 12 | 
| Change from baseline in waist circumference at month 6 | Previously described | Baseline and month 6 | 
| Change from baseline in minutes in moderate-to-vigorous physical activity per day at 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 | Previously described | Baseline and month 12 | 
| Change from baseline in minutes in moderate-to-vigorous physical activity per day at month 6 | Previously described | Baseline and month 6 | 
| Daily physical activity pattern | Asessed using wrist-worn smartwatches that are worn by the participants continously and measures steps, activity intensity and energy expenditure | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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