RE-inventing Strategies for Healthy Ageing; Recommendations and Tools

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2027-06-30

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:

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.

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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 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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Outcome assessors and data analysts will be blinded to group assignment from baseline to primary endpoint assessment. It is not possible to blind the participants or intervention staff due to the nature of the intervention.

Study Groups

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Complex lifestyle intervention

Receives a complex lifestyle intervention, a wrist-worn activity tracker, and access to national recommendations on physical activity.

Group Type EXPERIMENTAL

Complex lifestyle intervention

Intervention Type BEHAVIORAL

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.

Physical activity monitoring and recommendations

Intervention Type BEHAVIORAL

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 control

Receives a wrist-worn activity tracker and access to national recommendations on physical activity.

Group Type ACTIVE_COMPARATOR

Physical activity monitoring and recommendations

Intervention Type BEHAVIORAL

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.

Interventions

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Complex lifestyle intervention

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.

Intervention Type BEHAVIORAL

Physical activity monitoring and recommendations

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.

Intervention Type BEHAVIORAL

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

* 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

Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No