RE-inventing Strategies for Healthy Ageing; Recommendations and Tools

Muscle Weakness Clinical Trial

— RESTART  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06122441
• Other study ID #: 2023/584841(REK)
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: March 2024
• Source: University of Tromso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Norway	UiT The Arctic University of Norway	Tromsø	Troms

Sponsors (10)

Lead Sponsor	Collaborator
University of Tromso	KRAFT Sports Center, Molde University College, National Association for Heart and Lung Diseases, Tromso, Norway, Norwegian Trekking Association, Novo Nordisk A/S, The Research Council of Norway, Tromso Municipality, University Hospital of North Norway, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in relative body composition at 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
Other	Change from baseline in relative body composition at month 12	Previously described	Baseline and month 12
Other	Change from baseline in absolute body composition at month 24	Assessed as fat/lean/bone mass in grams using Dual-Energy X-ray Absorptiometry	Baseline and month 24
Other	Change from baseline in absolute body composition at month 12	Previously described	Baseline and month 12
Other	Change from baseline in health-related quality of life at 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
Other	Change from baseline in health-related quality of life at month 12	Previously described	Baseline and month 12
Other	Change from baseline in cognitive function using the Digit Symbol Substitution Test at month 24	Assessed as the number of symbols correctly matched with numbers within the allowed time	Baseline and month 24
Other	Change from baseline in cognitive function using the Digit Symbol Substitution Test at month 12	Previously described	Baseline and month 12
Other	Change from baseline in resting heart rate at month 24	Assessed as beats per minute three times in 1-minute intervals after an initial 2-minute rest	Baseline and month 24
Other	Change from baseline in resting heart rate at month 12	Previously described	Baseline and month 12
Other	Change from baseline in resting heart rate at month 6	Previously described	Baseline and month 6
Other	Change from baseline in systolic and diastolic blood pressure at month 24	Assessed as mmHg three times in 1-minute intervals after an initial 2-minute rest	Baseline and month 24
Other	Change from baseline in systolic and diastolic blood pressure at month 12	Previously described	Baseline and month 12
Other	Change from baseline in systolic and diastolic blood pressure at month 6	Previously described	Baseline and month 6
Other	Change from baseline in hand-held dynamometer-derived maximal handgrip strength at month 24	Assessed in kg and performed according to the Southampton protocol	Baseline and month 24
Other	Change from baseline in hand-held dynamometer-derived maximal handgrip strength at month 12	Previously described	Baseline and month 12
Other	Change from baseline in 5-repetition chair stand test performance at 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
Other	Change from baseline in 5-repetition chair stand test performance at month 12	Previously described	Baseline and month 12
Other	Change from baseline in glycated hemoglobin (HbA1C) at month 24	Assessed as % using non-fasted blood samples analysed with high-performance liquid chromatography	Baseline and month 24
Other	Change from baseline in glycated hemoglobin (HbA1C) at month 12	Previously described	Baseline and month 12
Other	Change from baseline in glycated hemoglobin (HbA1C) at month 6	Previously described	Baseline and month 6
Other	Change from baseline in blood lipids (total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides) at month 24	Assessed as mmol/l using non-fasted blood samples analysed with colorimetric (Homogen, or homogen enzymatic) methods	Baseline and month 24
Other	Change from baseline in blood lipids (total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides) at month 12	Previously described	Baseline and month 12
Other	Change from baseline in blood lipids (total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides) at month 6	Previously described	Baseline and month 6
Other	Change from baseline in satisfaction with life at month 24	Assessed with a 7-point likert scale using the 5-item Satisfaction With Life Scale (SWLS)	Baseline and month 24
Other	Change from baseline in satisfaction with life at month 12	Previously described	Baseline and month 12
Other	Change from baseline in mental distress on the 5-item Hopkins Symptom Checklist (HSCL-5) at month 24	Assessed with a 5-point likert scale using the 5-item Hopkins Symptom Checklist (HSCL-5)	Baseline and month 24
Other	Change from baseline in mental distress on the 5-item Hopkins Symptom Checklist (HSCL-5) at month 12	Previously described	Baseline and month 12
Other	Change from baseline in physical activity discomfort and acceptance on the 10-item Physical Activity Acceptance Questionnaire (PAAQ) at month 24	Assessed with a 7-point likert scale using the 10-item Physical Activity Acceptance Questionnaire (PAAQ)	Baseline and month 24
Other	Change from baseline in physical activity discomfort and acceptance on the 10-item Physical Activity Acceptance Questionnaire (PAAQ) at month 12	Previously described	Baseline and month 12
Other	Change from baseline in physical activity enjoyment on the 4-item Physical Activity Enjoyment Scale Short Form (PACES-S) at 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
Other	Change from baseline in physical activity enjoyment on the 4-item Physical Activity Enjoyment Scale Short Form (PACES-S) at month 12	Previously described	Baseline and month 12
Other	Change from baseline in emotional eating on the 3-item Emotional Eating Subscale from the Three-Factor Eating Questionnaire (TFEQ) at 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
Other	Change from baseline in emotional eating on the 3-item Emotional Eating Subscale from the Three-Factor Eating Questionnaire (TFEQ) at month 12	Previously described	Baseline and month 12
Other	Change from baseline in binge eating episodes on the Eating Disorder Examination (EDE) questionnaire at 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
Other	Change from baseline in binge eating episodes on the Eating Disorder Examination (EDE) questionnaire at month 12	Previously described	Baseline and month 12
Other	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	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
Other	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	Previously described	Baseline and month 12
Other	Change from baseline in self-efficacy on the 10-item General Self-Efficacy Scale (GSE) at month 24	Assessed with a 4-point likert scale using the 10-item General Self-Efficacy Scale (GSE)	Baseline and month 24
Other	Change from baseline in self-efficacy on the 10-item General Self-Efficacy Scale (GSE) at month 12	Previously described	Baseline and month 12
Other	Number of participants with intervention-related adverse events	Monitored consequently by intervention and outcome assessment personell	24 months
Primary	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
Primary	Change from baseline in VO2max at month 12	Previously described	Baseline and month 12
Primary	Change from baseline in VO2max at month 6	Previously described	Baseline and month 6
Secondary	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
Secondary	Change from baseline in muscle strength at month 12	Previously described	Baseline and month 12
Secondary	Change from baseline in muscle strength at month 6	Previously described	Baseline and month 6
Secondary	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
Secondary	Change from baseline in muscle power at month 12	Previously described	Baseline and month 12
Secondary	Change from baseline in muscle power at month 6	Previously described	Baseline and month 6
Secondary	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
Secondary	Change from baseline in waist circumference at month 12	Previously described	Baseline and month 12
Secondary	Change from baseline in waist circumference at month 6	Previously described	Baseline and month 6
Secondary	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
Secondary	Change from baseline in minutes in moderate-to-vigorous physical activity per day at month 12	Previously described	Baseline and month 12
Secondary	Change from baseline in minutes in moderate-to-vigorous physical activity per day at month 6	Previously described	Baseline and month 6
Secondary	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

External Links

•   Project webpage (only currently available in Norwegian)