Algarve Active Ageing - Cardiac and Osteoarthritis Rehabilitation: Personalized Physical Exercise Protocol in After Acute Myocardial Infarction or Cardiovascular Risk and Knee Osteoarthritis, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change the Level of Pain
研究概览
简要总结
This study aims to develop, implement, and determines the effectiveness of a personalized medicine approach to each individual's phenotype, based on an innovative physical exercise program to promote the treatment of pain and functional limitation resulting from knee osteoarthritis (KOA) in patients recovering after acute myocardial infarction (AMI) and cardiovascular risk (CVR).
This randomized clinical study is important due to the lack of evidence according to the effectiveness of a personalized physical exercise intervention in people after MI or CVR with simultaneous KOA.
Some studies have shown the existence of a relationship between OA and cardiovascular diseases (CVD), including coronary artery disease, stroke, congestive heart failure, peripheral arterial disease, cardiac procedures, or death related to CVD, since individuals with OA have a higher prevalence of CVD than individuals without OA.
Sedentary behaviour is a risk factor for AMI, CVR and KOA, and, at the same time, physical exercise is a common non-pharmacological treatment for people suffering from these conditions, namely in the control of joint pain, gains in functional capacity, and the improvement of cardiorespiratory functional capacity, whose impact can be felt in level of quality of life.
Chronic diseases have a significant impact on the global burden of disease, particularly CVD and OA, with the added presence of obesity also contributing to a high rate of all-cause morbidity and mortality, representing a substantial health burden and with growing implications for individuals, health systems and socioeconomic costs.
The presence of OA seems to lead to an increased risk of developing CVD. Several mechanisms have been proposed to explain this relationship. Chronic inflammation associated with OA is one of the hypotheses suggested to explain the increased risk of CVD in these individuals. Furthermore, the pain and disability associated with OA may also limit participation in exercise/physical activity, influencing other risk factors associated with both chronic diseases, such as weight gain.
The lack of studies about physical exercise intervention on people that suffered acute myocardial infarction or is in cardiovascular risk with simultaneous knee osteoarthritis and the lack of offer of phase III cardiac rehabilitation in Algarve motivated the development of this study, with the assumption of adopting a healthier lifestyle.
详细描述
A new exercise protocol (A3-COR Protocol) for patients with knee osteoarthritis (OA) recovering after acute myocardial infarction (AMI) or with cardiovascular risk (CVR) was developed and implemented. The purpose of the A3-COR protocol is to improve quality of life, functionality, and pain, through regular physical exercise facilitating an active and healthy lifestyle.
This clinical trial includes 2 parallel intervention groups with a pre- and post-test analysis. In the exercise group (EG), the participants will receive a twelve weeks of a supervised personalised exercise program and in the control group (CG) there will be no intervention. Both groups will have a behavioral change session with a psychologist to promote changes in lifestyle and a session with a nutritionist to promote healthy eating habits.
Both groups will be assessed two times, the pre-test in the beginning of the study (T0-Baseline) before starting the intervention or control and the post-test taking place at the end of 12 weeks (T1-Post-test).
The sample includes subjects from the community who met the defined eligibility criteria. Participation in the study is voluntary and sample recruitment will be carried out through publicity materials, such as flyers posted at senior universities, institutions/associations, municipalities, parish councils, sports complexes, health centres, among other public spaces of interest.
To calculate the sample size, the software G*Power was used. The primary outcome for this clinical trial was the knee-related pain, measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS) with is a self-reported outcome with five subscales: 1) Symptoms+Stiffness; 2) Pain; 3) Function, daily living; 4) Function, sports and recreational activities and 5) Quality of Life, all score 0-100. According to the literature, an important clinical difference in the KOOS subscales has been suggested to be 8 to 10 points. Based on the expected difference of 10 points between the intervention and control groups and a standard deviation of 20 in Pain, 64 patients were required in each group with a significance level of 0.05 and power of 80%. With an estimated dropout rate of 10%, a total number of 142 subjects will be randomized to the EG (n = 71) and to the CG (n = 71).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 or older; Knee pain, Morning stiffness that lasts no longer than 30 minutes and one of the following: crepitus, restricted function, bony enlargement. Acute Myocardial Infarction with myocardial lesion detected by abnormal cardiac biomarkers evidencing acute myocardial ischemia; High risk level in the Systematic Coronary Risk Evaluation (SCORE2) or the Systematic Coronary Risk Evaluation Older Person (SCORE2 O.P.) cardiovascular risk algorithm or prior cardiovascular disease; Independent gait
排除标准
- •Occurrence of acute myocardial infarction with less than 12 months; Cognitive impairment- Montreal Cognitive Assessment (MoCA); Type 1 diabetes or insulin dependence; Pacemaker device; Knee prosthesis; Currently doing formal exercise session for more that 30 minutes per week; Class III or IV angina according to Canadian Cardiovascular Society criteria; Class III or IV symptoms according to New York Heart Association criteria; Type 2 Myocardial Infarction; Uncontrolled and symptomatic cardiac arrythmia with hemodynamic impact; Severe and symptomatic aortic valve stenosis; Uncontrolled and symptomatic heart failure; Active myocarditis, pericarditis or endocarditis; Acute aortic syndrome; Known or suspected desiccant aneurism; Acute systemic infection.
结局指标
主要结局
Change the Level of Pain
时间窗: 12 weeks
Significant increase in pain subscore of Knee Injury and Osteoarthritis Outcome Score. The subscore can range between 0-100% and higher values mean less pain.
Change the 40m Fast Paced Walk Test Performance
时间窗: 12 weeks
Significant decrease in time (seconds) of performance in 40m fast paced walk test. Higher time of performance means poorer physical function.
Change the 6 Minutes Walk Test Performance
时间窗: 12 weeks
Significant increase in distance (meters) in 6 Minutes Walk Test. Higher distance in 6 minutes means better physical function.
Change in Peak Torque of Quadriceps and Hamstring Muscles
时间窗: 12 weeks
Significant increase in peak torque (N/m). Peak Torque of Quadriceps and Hamstring Muscles will be measured by a fixed dynamometer with concentric/concentric action at an angular velocity of 60º per second for 5 repetitions of extension and flexion of each knee.
Change the 30-Second Chair Stand Test Performance
时间窗: 12 weeks
Significant increase of number of repetitions in 30-second chair stand test. Higher number of repetitions in 30 seconds means better physical function.
Change in Work of Quadriceps and Hamstring Muscles
时间窗: 12 weeks
Significant increase in work per repetition (N/m). Work of Quadriceps and Hamstring Muscles will be measured by a fixed dynamometer with concentric/concentric action at an angular velocity of 60º per second for 5 repetitions of extension and flexion of each knee.
Change in Power of Quadriceps and Hamstring Muscles
时间窗: 12 weeks
Significant increase in power per repetition (N/m). Power of Quadriceps and Hamstring Muscles will be measured by a fixed dynamometer with concentric/concentric action at an angular velocity of 60º per second for 5 repetitions of extension and flexion of each knee.
Change in Peak torque time of Quadriceps and Hamstring Muscles
时间窗: 12 weeks
Significant increase in Peak torque time (s). Peak torque time of Quadriceps and Hamstring Muscles will be measured by a fixed dynamometer with concentric/concentric action at an angular velocity of 60º per second for 5 repetitions of extension and flexion of each knee.
Change in Force of Quadriceps and Hamstring Muscles
时间窗: 12 weeks
Significant increase in Force (kg). Force of Quadriceps and Hamstring Muscles will be measured by a fixed dynamometer with concentric/concentric action at an angular velocity of 60º per second for 5 repetitions of extension and flexion of each knee.
Change the Level of Function
时间窗: 12 weeks
Significant increase in both function subscores of Knee Injury and Osteoarthritis Outcome Score. The subscores can range between 0-100% and higher values mean better function.
Change the Time Up and Go Test Performance
时间窗: 12 weeks
Significant decrease in time (seconds) to perform the Timed Up and Go (TUG) test. Higher time of performance means poorer physical function.
Change the Stair Climb Test Performance
时间窗: 12 weeks
Significant decrease in time (seconds) of performance in Stair Climb Test (9 steps). Higher time of performance means poorer physical function.
Change in Quality of Life
时间窗: 12 weeks
Significant increase in any subscore or total score of Medical Outcomes Study 36-item Short-Form Health Survey (SF-36), used to assess quality of life. Instrument can range between 0-100 and higher values mean better self-precepted quality of life.
Change in Maximal Oxygen Uptake (VO2max)
时间窗: 12 weeks
Significant increase in Maximal Oxygen Uptake (VO2max). Higher VO2max means better cardiorespiratory function. The VO2max will be evaluated through the exercise cardiorespiratory test with progressive increase of the external load by the manipulation of the velocity or inclination.
Change in First Ventilatory Threshold (VT1 - VO2)
时间窗: 12 weeks
Significant increase in First Ventilatory Threshold (VT1 - VO2). Higher VT1 means better cardiorespiratory function. The VT1 will be evaluated through the exercise cardiorespiratory test with progressive increase of the external load by the manipulation of the velocity or inclination.
Change in Respiratory Compensation Point (RCP - VO2)
时间窗: 12 weeks
Significant increase in Respiratory Compensation Point (RCP - VO2). Higher RCP means better cardiorespiratory function. The RCP will be evaluated through the exercise cardiorespiratory test with progressive increase of the external load by the manipulation of the velocity or inclination.
次要结局
- Change in maximal displacement of vastus lateralis and medialis, biceps femoris and semitendinous(12 weeks)
- Change in contraction time of vastus lateralis and medialis, biceps femoris and semitendinous(12 weeks)
- Change in fat mass(12 weeks)
- Change in fat-free mass(12 weeks)
- Change in fat mass index(12 weeks)
- Change in Weight(12 weeks)
- Change in body mass index(12 weeks)
- Change in Rescue's Pain Medication Posology(12 weeks)
- Change in fat-free mass index(12 weeks)
- Change in muscle mass index(12 weeks)
- Change in fat visceral fat(12 weeks)
- Change in total body water(12 weeks)
- Monitoring phase angle(12 weeks)
- Change medical appointments number related with Knee Osteoarthritis(12 weeks)
- Change in abdominal circumference(12 weeks)
- Change in Hand Grip Strength(12 weeks)
- Change in hospital readmissions related to Myocardial Infarction(12 weeks)
- Change medical appointments number related with Myocardial Infarction(12 weeks)
研究者
Sandra Rafael Pais
Researcher
Associação para o Desenvolvimento do Centro Académico de Investigação e Formação Biomédica do Algarv