RE-inventing Strategies for Healthy Ageing; Recommendations and Tools
- Conditions
- Lifestyle, HealthySelf EfficacyCardiometabolic SyndromeDiet, HealthyMuscle WeaknessAbdominal Obesity
- Interventions
- Behavioral: Complex lifestyle interventionBehavioral: Physical activity monitoring and recommendations
- Registration Number
- NCT06122441
- Lead Sponsor
- University of Tromso
- 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. Produced a clinically relevant increase in cardiorespiratory fitness (primary endpoint)
2. Increased muscle strength, physical activity and reduced adiposity
3. 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
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 12, 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 12, 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 12 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 119
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Complex lifestyle intervention Complex lifestyle intervention Receives a complex lifestyle intervention, a wrist-worn activity tracker, and access to national recommendations on physical activity. Complex lifestyle intervention Physical activity monitoring and recommendations Receives a complex lifestyle intervention, a wrist-worn activity tracker, and access to national recommendations on physical activity. Active control Physical activity monitoring and recommendations Receives a wrist-worn activity tracker and access to national recommendations on physical activity.
- Primary Outcome Measures
Name Time Method Change from baseline in VO2max at month 24 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.
Change from baseline in VO2max at month 12 Baseline and month 12 Assessed as ml/kg/min during an incremental test-to-exhaustion where the participant walks or runs on a motorized treadmill.
Change from baseline in VO2max at month 6 Baseline and month 6 Assessed as ml/kg/min during an incremental test-to-exhaustion where the participant walks or runs on a motorized treadmill.
- Secondary Outcome Measures
Name Time Method Change from baseline in muscle strength at month 24 Baseline and month 24 Assessed as the highest kg achieved during a 1-repetition maximum test in leg-press and chest-press apparatuses.
Change from baseline in muscle strength at month 12 Baseline and month 12 Assessed as the highest kg achieved during a 1-repetition maximum test in leg-press and chest-press apparatuses.
Change from baseline in muscle strength at month 6 Baseline and month 6 Assessed as the highest kg achieved during a 1-repetition maximum test in leg-press and chest-press apparatuses.
Change from baseline in muscle power at month 24 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
Change from baseline in muscle power at month 12 Baseline and month 12 Assessed as power (W; force x speed of contraction) during leg-press exercise with pre-defined weight ascertained during baseline measurements
Change from baseline in muscle power at month 6 Baseline and month 6 Assessed as power (W; force x speed of contraction) during leg-press exercise with pre-defined weight ascertained during baseline measurements
Change from baseline in waist circumference at month 24 Baseline and month 24 Assessed in centimeters at the umbilical level (between crista iliaca and the lower rib) using a measurement tape.
Change from baseline in waist circumference at month 12 Baseline and month 12 Assessed in centimeters at the umbilical level (between crista iliaca and the lower rib) using a measurement tape.
Change from baseline in waist circumference at month 6 Baseline and month 6 Assessed in centimeters at the umbilical level (between crista iliaca and the lower rib) using a measurement tape.
Change from baseline in body weight at month 24 Baseline and month 24 Assessed in kilograms using a SECA personal weight. Participants are measured without outdoor clothing and shoes.
Change from baseline in body weight at month 12 Baseline and month 12 Assessed in kilograms using a SECA personal weight. Participants are measured without outdoor clothing and shoes.
Change from baseline in body weight at month 6 Baseline and month 6 Assessed in kilograms using a SECA personal weight. Participants are measured without outdoor clothing and shoes.
Change from baseline in minutes in moderate-to-vigorous physical activity per day at month 24 Baseline and month 24 Assessed as minutes in light, moderate and vigorous intensity, using triaxial accelerometers worn at the hip for 7 days.
Change from baseline in minutes in moderate-to-vigorous physical activity per day at month 12 Baseline and month 12 Assessed as minutes in light, moderate and vigorous intensity, using triaxial accelerometers worn at the hip for 7 days.
Change from baseline in minutes in moderate-to-vigorous physical activity per day at month 6 Baseline and month 6 Assessed as minutes in light, moderate and vigorous intensity, using triaxial accelerometers worn at the hip for 7 days.
Daily physical activity pattern 24 months Asessed using wrist-worn smartwatches that are worn by the participants continously and measures steps, activity intensity and energy expenditure
Trial Locations
- Locations (1)
UiT The Arctic University of Norway
🇳🇴Tromsø, Troms, Norway