Algarve Active Ageing - Cardiac and Osteoarthritis Rehabilitation (A3-COR)

NCT05999110 | Recruiting

• 1 other identifier: 072590 - A3-COR
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis, Knee; Myocardial Infarction, Acute; Hypertension; Dyslipidemias; Type 2 Diabetes; Smoking Habit

Keywords

Knee Osteoarthritis; Acute Myocardial Infarction; Cardiovascular Risk; Personalized Medicine; Healthy Ageing; Exercise; Personalized Exercise

Outcome Measures

Primary Outcomes (16)

• Change the Level of Pain

  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.

  12 weeks

• Change the Level of Function

  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.

  12 weeks

• Change the Time Up and Go Test Performance

  Significant decrease in time (seconds) to perform the Timed Up and Go (TUG) test. Higher time of performance means poorer physical function.

  12 weeks

• Change the 30-Second Chair Stand Test Performance

  Significant increase of number of repetitions in 30-second chair stand test. Higher number of repetitions in 30 seconds means better physical function.

  12 weeks

• Change the 40m Fast Paced Walk Test Performance

  Significant decrease in time (seconds) of performance in 40m fast paced walk test. Higher time of performance means poorer physical function.

  12 weeks

• Change the Stair Climb Test Performance

  Significant decrease in time (seconds) of performance in Stair Climb Test (9 steps). Higher time of performance means poorer physical function.

  12 weeks

• Change the 6 Minutes Walk Test Performance

  Significant increase in distance (meters) in 6 Minutes Walk Test. Higher distance in 6 minutes means better physical function.

  12 weeks

• Change in Quality of Life

  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.

  12 weeks

• Change in Peak Torque of Quadriceps and Hamstring Muscles

  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.

  12 weeks

• Change in Work of Quadriceps and Hamstring Muscles

  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.

  12 weeks

• Change in Power of Quadriceps and Hamstring Muscles

  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.

  12 weeks

• Change in Peak torque time of Quadriceps and Hamstring Muscles

  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.

  12 weeks

• Change in Force of Quadriceps and Hamstring Muscles

  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.

  12 weeks

• Change in Maximal Oxygen Uptake (VO2max)

  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.

  12 weeks

• Change in First Ventilatory Threshold (VT1 - VO2)

  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.

  12 weeks

• Change in Respiratory Compensation Point (RCP - VO2)

  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.

  12 weeks

Secondary Outcomes (18)

• 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 Weight

  12 weeks

• Change in body mass index

  12 weeks

• Change in fat mass

  12 weeks

Study Arms (2)

Exercise Group

EXPERIMENTAL

The participants receive twelve weeks of a supervised personalised exercise program, based on aerobic and strength training. This group also receives a behavioral change session with a psychologist and nutritional advice session with a nutritionist.

Other: Physical Exercise

Control Group

NO INTERVENTION

This group receive no exercise intervention. The group receives equally as the exercise group, a behavioral change session with a psychologist and nutritional advice session with a nutritionist.

Interventions

Physical Exercise OTHER

The intervention includes a personalized physical exercise program based on aerobic and strength training, with prior warm-up and post cool-down exercises. All participants also receive a nutritional advice session and a behavioral changes session.

Exercise Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Associação para o Desenvolvimento do Centro Académico de Investigação e Formação Biomédica do Algarv: lead
• European Regional Development Fund: collaborator
• Loulé Municipal Council: collaborator
• Albufeira Municipal Council: collaborator
• Quarteira Parish Council: collaborator

Study Sites (1)

AD-ABC

Faro, Algarve, 8005-139, Portugal

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Myocardial Infarction; Hypertension; Dyslipidemias; Diabetes Mellitus, Type 2; Smoking; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sandra R Pais, PhD

  AD-ABC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta S Botelho, PhD

CONTACT

+351 916785430; marta.botelho@abcmedicalg.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: Participants are being assigned for two groups in parallel and a pre and post-test analysis is being performed.

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 21, 2023
• Study Start: June 1, 2022
• Primary Completion: May 31, 2024
• Study Completion: December 20, 2024
• Last Updated: February 8, 2024

Record last verified: 2024-02

Locations

PT (1)