Clinical trial NCT06122441: RE-inventing Strategies for Healthy Ageing; Recommendations and Tools
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lifestyle, Healthy
Muscle Weakness
Abdominal Obesity
Cardiometabolic Syndrome
Self Efficacy
Diet, Healthy
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
Lead sponsor: University of Tromso
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: Novo Nordisk A/S
name: Tromso Municipality
name: University Hospital of North Norway
name: University of Oslo
name: Molde University College
name: National Association for Heart and Lung Diseases, Tromso, Norway
name: Norwegian Trekking Association
name: KRAFT Sports Center
First posted: 2023-11-08
Enrollment: 119
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: PREVENTION

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Change from baseline in VO2max at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in VO2max at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in VO2max at month 6
timeFrame: Baseline and month 6
Secondary outcomes:
measure: Change from baseline in muscle strength at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in muscle strength at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in muscle strength at month 6
timeFrame: Baseline and month 6
measure: Change from baseline in muscle power at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in muscle power at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in muscle power at month 6
timeFrame: Baseline and month 6
measure: Change from baseline in waist circumference at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in waist circumference at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in waist circumference at month 6
timeFrame: Baseline and month 6
measure: Change from baseline in body weight at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in body weight at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in body weight at month 6
timeFrame: Baseline and month 6
measure: Change from baseline in minutes in moderate-to-vigorous physical activity per day at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in minutes in moderate-to-vigorous physical activity per day at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in minutes in moderate-to-vigorous physical activity per day at month 6
timeFrame: Baseline and month 6
measure: Daily physical activity pattern
timeFrame: 24 months
Other outcomes:
measure: Change from baseline in relative body composition at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in relative body composition at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in absolute body composition at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in absolute body composition at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in health-related quality of life at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in health-related quality of life at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in cognitive function using the Digit Symbol Substitution Test at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in cognitive function using the Digit Symbol Substitution Test at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in forced expiratory volume (FEV1) at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in forced vital capacity (FVC) at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in peak expiratory flow (PEF) at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in resting heart rate at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in resting heart rate at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in resting heart rate at month 6
timeFrame: Baseline and month 6
measure: Change from baseline in systolic and diastolic blood pressure at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in systolic and diastolic blood pressure at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in systolic and diastolic blood pressure at month 6
timeFrame: Baseline and month 6
measure: Change from baseline in hand-held dynamometer-derived maximal handgrip strength at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in hand-held dynamometer-derived maximal handgrip strength at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in 5-repetition chair stand test performance at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in 5-repetition chair stand test performance at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in satisfaction with life at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in satisfaction with life at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in mental distress on the 10-item Hopkins Symptom Checklist (HSCL-5) at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in mental distress on the 10-item Hopkins Symptom Checklist (HSCL-5) at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in physical activity discomfort and acceptance on the 10-item Physical Activity Acceptance Questionnaire (PAAQ) at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in physical activity discomfort and acceptance on the 10-item Physical Activity Acceptance Questionnaire (PAAQ) at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in physical activity enjoyment on the 4-item Physical Activity Enjoyment Scale Short Form (PACES-S) at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in physical activity enjoyment on the 4-item Physical Activity Enjoyment Scale Short Form (PACES-S) at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in emotional eating on the 3-item Emotional Eating Subscale from the Three-Factor Eating Questionnaire (TFEQ) at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in emotional eating on the 3-item Emotional Eating Subscale from the Three-Factor Eating Questionnaire (TFEQ) at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in binge eating episodes on the Eating Disorder Examination (EDE) questionnaire at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in binge eating episodes on the Eating Disorder Examination (EDE) questionnaire at month 12
timeFrame: Baseline and month 12
measure: 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
timeFrame: Baseline and month 24
measure: 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
timeFrame: Baseline and month 12
measure: Change from baseline in self-efficacy on the 10-item General Self-Efficacy Scale (GSE) at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in self-efficacy on the 10-item General Self-Efficacy Scale (GSE) at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in self-compassion on the 6-item Self-Compassion Scale at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in self-compassion on the 6-item Self-Compassion Scale at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in self-reported education status at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in self-reported household income at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in self-reported occupation status at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in self-reported occupation status at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in self-reported occupation status at month 6
timeFrame: Baseline and month 6
measure: Change from baseline in self-reported ideal weight at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in self-reported ideal weight at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in self-reported chronic disease at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in self-reported chronic disease at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in self-reported symptoms and complaints at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in self-reported symptoms and complaints at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in self-reported medicine use at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in self-reported medicine use at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in self-reported medicine use at month 6
timeFrame: Baseline and month 6
measure: Change from baseline in self-reported social network at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in self-reported social network at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in self-reported tobacco use at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in self-reported tobacco use at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in self-reported alcohol use at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in self-reported alcohol use at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in self-rated health at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in self-rated health at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in self-reported leisure time physical activity level at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in self-reported leisure time physical activity level at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in self-reported diet using the NORKOST Food Frequency Questionnaire at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in self-reported diet using the NORKOST Food Frequency Questionnaire at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in hemoglobin (Hb) and glycated hemoglobin (HbA1C) at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in hemoglobin (Hb) and glycated hemoglobin (HbA1C) at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in hemoglobin (Hb) and glycated hemoglobin (HbA1C) at month 6
timeFrame: Baseline and month 6
measure: Change from baseline in blood lipids (total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides) at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in blood lipids (total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides) at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in blood lipids (total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides) at month 6
timeFrame: Baseline and month 6
measure: Change from baseline in renal function markers (cystatin C, creatinine) at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in renal function markers (cystatin C, creatinine) at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in renal function markers (cystatin C, creatinine) at month 6
timeFrame: Baseline and month 6
measure: Baseline levels of markers of thyroid function (thyroxin, thyroid-stimulating hormone)
timeFrame: Baseline
measure: Change from baseline in liver enzymes (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase) at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in liver enzymes (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase) at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in phosphatidylethanol at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in phosphatidylethanol at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in testosterone at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in testosterone at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in C-reactive protein at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in C-reactive protein at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in albumin-creatinine ratio at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in albumin-creatinine ratio at month 12
timeFrame: Baseline and month 12
measure: Change from baseline in albumin-creatinine ratio at month 6
timeFrame: Baseline and month 6
measure: Change from baseline in ECG PQ-interval at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in ECG P-wave at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in ECG QRS-complex at month 24
timeFrame: Baseline and month 24
measure: Change from baseline in ECG T-wave at month 24
timeFrame: Baseline and month 24
measure: Participants' experiences of receiving a complex lifestyle intervention
timeFrame: 24 months
measure: Assessment of the cost-effectiveness of receiving the intervention versus not receiving the intervention, over a 24-month period
timeFrame: 24 months
measure: Number of participants with CVD events (myocardial infarction, stroke), diabetes and premature deaths
timeFrame: 60 months
measure: Number of participants with intervention-related adverse events
timeFrame: 24 months
Locations:
city: Tromsø
country: Norway
facility: UiT The Arctic University of Norway
state: Troms
Study officials:
affiliation: UiT The Arctic University of Norway
name: Sameline Grimsgaard, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UiT The Arctic University of Norway
name: Jonas Johansson, PhD
role: STUDY_DIRECTOR
affiliation: UiT The Arctic University of Norway
name: Trygve Deraas, PhD
role: STUDY_DIRECTOR
affiliation: UiT The Arctic University of Norway
name: Camilla Flåten, MSc
role: STUDY_DIRECTOR
affiliation: UiT The Arctic University of Norway
name: André Henriksen, PhD
role: STUDY_DIRECTOR
affiliation: UiT The Arctic University of Norway
name: Laila Hopstock, PhD
role: STUDY_DIRECTOR
References: