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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Change from baseline in VO2max at month 24
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Complex lifestyle intervention
Receives a complex lifestyle intervention, a wrist-worn activity tracker, and access to national recommendations on physical activity.
干预措施: Complex lifestyle intervention (Behavioral)
Complex lifestyle intervention
Receives a complex lifestyle intervention, a wrist-worn activity tracker, and access to national recommendations on physical activity.
干预措施: Physical activity monitoring and recommendations (Behavioral)
Active control
Receives a wrist-worn activity tracker and access to national recommendations on physical activity.
干预措施: Physical activity monitoring and recommendations (Behavioral)
结局指标
主要结局
Change from baseline in VO2max at month 24
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change from baseline in muscle strength at month 24(Baseline and month 24)
- Change from baseline in muscle strength at month 12(Baseline and month 12)
- Change from baseline in muscle strength at month 6(Baseline and month 6)
- Change from baseline in muscle power at month 24(Baseline and month 24)
- Change from baseline in muscle power at month 12(Baseline and month 12)
- Change from baseline in muscle power at month 6(Baseline and month 6)
- Change from baseline in waist circumference at month 24(Baseline and month 24)
- Change from baseline in waist circumference at month 12(Baseline and month 12)
- Change from baseline in waist circumference at month 6(Baseline and month 6)
- Change from baseline in body weight at month 24(Baseline and month 24)
- Change from baseline in body weight at month 12(Baseline and month 12)
- Change from baseline in body weight at month 6(Baseline and month 6)
- Change from baseline in minutes in moderate-to-vigorous physical activity per day at month 24(Baseline and month 24)
- Change from baseline in minutes in moderate-to-vigorous physical activity per day at month 12(Baseline and month 12)
- Change from baseline in minutes in moderate-to-vigorous physical activity per day at month 6(Baseline and month 6)
- Daily physical activity pattern(24 months)