Osteoarthritis PainCPEPCDNCT06771024
Community Physical Exercise Program in Chronic Disease
A study testing Physical Exercise in people with Osteoarthritis Pain and Myocardial Infarction (MI), run by Associação para o Desenvolvimento do Centro Académico de Investigação e Formação Biomédica do Algarv at 1 site in Portugal.
Trial summary
This study focuses on promoting physical activity (PA) through the implementation of a Community Physical Exercise Program for Chronic Diseases (CPEP-CD), targeting individuals aged 50 years and older with at least two of the following conditions: cardiovascular and/or cerebrovascular disease or risk (CVD)… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis Pain, Myocardial Infarction (MI), Hypertension
- What is being tested?
- Physical Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePortugal
- Study dates
- Oct 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥50 years;
- At least 2 of the following: Prior cardiovascular disease (>12 months); High cardiovascular risk (SCORE2 or SCORE2 O.P.); Post-stroke (ischemic or hemorrhagic) with treated etiology; Type 2 Diabetes (> 6 months, ADA); Osteoarthristis (clinical signs/symptoms, NICE); Overweight/Obesity (BMI ≥ 27 kg/m2).
- Autonomous walking.
- Able to provide informed consent.
- Stable medications for ≥ 3 months (related to diagnoses of interest).
- Physical activity below WHO recommendations.
- No contraindications to exercise (cardiovascular, cerebrovascular, respiratory, musculoskeletal) according to ACSS.
Who cannot join
- Moderate to severe cognitive impairment - Montreal Cognitive Assessment (MoCA).
- Type 2 Myocardial Infarction.
- Class III or IV angina (Canadian Cardiovascular Society).
- Class III or IV angina (New York Heart Association).
- Uncontrolled CVD: symptomatic arrhythmias with hemodynamic compromise; severe symptomatic aortic valve stenosis; uncontrolled symptomatic heart failure; endocarditis, pericarditis, or active myocarditis; acute aortic syndrome; suspected or known dissecting aneurysm; acute systemic infections.
- Pacemaker user.
Show all 14Show fewer
- Neurological disorders affecting gait.
- Severe diabetes-related complications contraindicating exercise (poor metabolic control, diabetic foot, diabetic retinopathy, diabetic nephropathy, and diabetic autonomic neuropathy).
- Recent use of insulin or sulphonylureas (< 3 months).
- Untreated stroke etiology: indication for revascularization; non-anticoagulated atrial fibrillation; intracranial atherosclerotic occlusive disease.
- Musculoskeletal or ocular conditions preventing strength training (acute herniated disc, fractures, recent spinal surgery, glaucoma with elevated intraocular pressure).
- Terminal illness.
- Inability to understand basic oral or written Portuguese.
- Participation in supervised dietary intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
Algarve Biomedical Center
Faro, Algarve, 8005-139
Marta S Botelho, PhD, +351 916785430, marta.botelho@abcmedicalg.pt
About this study
Official title: Effectiveness of Community Physical Exercise Program in Chronic Disease (CPEP - Chronic Disease), a Clinical Randomized Controlled Trial
This study focuses on promoting physical activity (PA) through the implementation of a Community Physical Exercise Program for Chronic Diseases (CPEP-CD), targeting individuals aged 50 years and older with at least two of the following conditions: cardiovascular and/or cerebrovascular disease or risk (CVD), overweight, diabetes mellitus (DM), and musculoskeletal diseases. The primary objective is to improve muscle and cardiorespiratory health and well-being, while also contributing to a more objective and evidence-based exercise prescription for these pathological conditions.
Population ageing is a global challenge associated with an increased prevalence of chronic diseases that compromise quality of life (QoL). A sedentary lifestyle is linked to declines in muscle function and cardiorespiratory fitness and is considered a major risk factor for morbidity and mortality. Consequently, physical exercise is widely recommended as a key non-pharmacological intervention across multiple chronic diseases.
Read more
According to World Health Organization (WHO) guidelines, regular PA is a protective factor in the prevention and management of non-communicable diseases, including cardiovascular and cerebrovascular diseases and DM. In addition, PA provides mental health benefits, supports healthy weight maintenance, and enhances overall well-being. In adults, regular PA is associated with reductions in all-cause mortality, cardiovascular mortality, and the incidence of hypertension.
Within this context, the aim of this project is to implement a community-based physical exercise program for individuals with chronic disease and multimorbidity, focusing on CVD and cerebrovascular disease or risk, DM, and OA. The program integrates existing exercise prescription guidelines while personalizing exercise progression according to both disease-specific and multimorbidity profiles. The primary outcomes include improvements in cardiorespiratory fitness, muscular strength, bone health, functional capacity, and QoL. Additionally, through individualized training monitoring, this study seeks to establish an exercise prescription tailored to the most prevalent combinations of chronic diseases, thereby providing more objective and practical guidance for family physicians, exercise professionals, and rehabilitation specialists, and supporting more personalized and targeted exercise-based strategies for chronic disease prevention and management.
Read the detailed description
The implementation of exercise programs in individuals with chronic disease is essential for modifying cardiovascular and metabolic risk factors. However, it is equally important to examine not only the direct effects of exercise on health and well-being outcomes, but also to quantify the most appropriate training load, particularly in the presence of multimorbidity.
This is a non-pharmacological clinical study with two parallel intervention groups and a pre-post study design. Participants allocated to the Exercise Group (EG) will undertake a 12-week supervised physical exercise program, while those in the Control Group (CG) will receive no intervention during the study period.
Both groups will be assessed at two time points: (1) baseline assessment (T0) and (2) post-intervention assessment after 12 weeks (T12). The Community Physical Exercise Program (CPEP) will last 12 weeks, with two sessions per week, each lasting 60 minutes. International and national exercise prescription guidelines will be applied for each clinical condition, namely cardiovascular and/or cerebrovascular disease or risk, diabetes mellitus, and osteoarthritis. All variables will be assessed and monitored by qualified health and exercise professionals using reliable and validated instruments and equipment.
The training sessions will combine cardiorespiratory exercises aimed at improving aerobic capacity with strength training, particularly resistance exercises, using body weight and auxiliary equipment. Training intensity zones will be individualized and defined according to each participant's baseline cardiorespiratory fitness test results and subjective perception of effort.
The sample will include individuals aged 50 years or older with at least one of the aforementioned chronic conditions. Participation will be voluntary, and recruitment will be conducted through dissemination materials placed in senior universities, institutions and associations, municipalities, parish councils, sports facilities, health centers, and other relevant public spaces.
The sampling process will consist of an initial phase of non-random purposive sampling, followed by a second phase using snowball sampling if necessary. Sample size was calculated using G*Power software (version 3.1.9.7), assuming a two-tailed α level of 0.05, an effect size of 0.5, statistical power of 80%, and an anticipated dropout rate of 15%. A total sample of 147 participants will be required, with 74 participants allocated to each group.
Cardiovascular risk screening will be conducted based on the presence of one or more of the following risk factors: hypertension, dyslipidemia, or smoking, in accordance with SCORE2 or SCORE2-OP. For the other pathological conditions, definitions and criteria will be used in accordance with the recommendations of European or American scientific societies.
Following the intervention, the expected outcomes include improvements in cardiorespiratory fitness, muscular strength and muscle function, bone health, joint pain, physical function, quality of life, biochemical parameters related to glycemic and lipid profiles, and body composition. Additionally, the study aims to quantify the average training load and its progression over the intervention period.
- Conditions
- Osteoarthritis Pain, Myocardial Infarction (MI), Hypertension, Dyslipidemia, Diabetes Mellitus, Overweight , Obesity
- Being tested
- Physical Exercise
- Keywords
- Physical Exercise Program, Healthy Ageing, Cardiovascular Risk, Osteoarthritis, Multimorbility, Chronic Diseases, Diabetes Mellitus, Cerebrovascular risk
- Medical subject headings
- Myocardial Infarction, Hypertension, Dyslipidemias, Diabetes Mellitus, Overweight, Obesity, Stroke, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ExerciseBehavioural
The intervention include a personalized physical exercise program based on aerobic and strength training, with prior warm-up and post cool-down exercises. International/national exercise prescription guidelines will be applied for each clinical condition (cardio/cerebrovascular disease/risk, diabetes mellitus and osteoarthritis). The main exercise component consists of concurrent training, combining resistance and aerobic exercises. The aims are to enhance muscle strength and endurance, improve self-confidence, increase the ability to perform activities of daily living, maintain independence, and reduce cardiac demands during daily activities (as indicated by a lower heart rate-pressure product). Training intensity is monitored using heart rate (HR) sensors. Blood pressure, HR, peripheral oxygen saturation (SpO₂), perceived exertion (Modified Borg Scale - MBS), and other relevant events are recorded in a daily log.
| Study group | Role | What they receive |
|---|---|---|
| Community Physical Exercise Program Group | Experimental | The participants receive a twelve weeks of a supervised physical exercise program, based on aerobic and strength training. Receives: Behavioral: Physical Exercise |
| Control Group | No intervention | Participants do not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak Oxygen Uptake (VO2peak)
Significant increase in Peak Oxygen Uptake (VO2peak). Higher VO2peak means better cardiorespiratory function. The VO2peak will be evaluated through the exercise cardiorespiratory test with progressive increase of the external load in a cycle ergometer.
Measured: 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 in a cycle ergometer.
Measured: 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 in a cycle ergometer.
Measured: 12 weeks
Change in peak torque of quadriceps and hamstring muscles
A significant increase in peak torque (N/m). Peak torque of the quadriceps and hamstring muscles will be measured using a fixed dynamometer with concentric-concentric actions at an angular velocity of 60° per second, during five maximal repetitions of knee extension and flexion for each knee.
Measured: 12 weeks
Change in work of quadriceps and hamstring muscles
A significant increase in work per repetition (N/m). Work of the quadriceps and hamstring muscles will be measured using a fixed dynamometer with concentric-concentric actions at an angular velocity of 60° per second, during five maximal repetitions of knee extension and flexion for each knee.
Measured: 12 weeks
Change in power of quadriceps and hamstring muscles
A significant increase in power per repetition (W). Peak torque of the quadriceps and hamstring muscles will be measured using a fixed dynamometer with concentric-concentric actions at an angular velocity of 60° per second, during five maximal repetitions of knee extension and flexion for each knee.
Measured: 12 weeks
Secondary outcomes (25)
Change in lower limb functionality (number of repetions)
A significant increase in lower limb functional performance, reflected by an increased number of repetitions, is expected. Lower limb functionality will be assessed using the 30-Second Sit-to-Stand Test (30STS).
Measured: 12 weeks
Change in functional mobility (seconds)
A significant improvement in functional mobility, reflected by a decrease in the time required to complete the Timed Up and Go (TUG) test, is expected. The TUG test will be performed with participants rising from a standard chair, walking 3 meters at a comfortable pace, turning, returning to the chair, and sitting down.
Measured: 12 weeks
Change in Oscillation of the Center of Pressure
The balance analysis will be carried out using an AMTI® force platform, which will allow determining the displacement and oscillation of the static center of pressure (CP) with participants in 2 conditions: eyes open and eyes closed (duration of 30 seconds for each assessment).
Measured: 12 weeks
Change in Health-Related Quality of Life
A significant improvement in health-related quality of life (HRQoL) is expected. HRQoL will be assessed using the EQ-5D-5L questionnaire (EuroQol Group), which evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension comprises five levels of severity, ranging from 1 (no problems) to 5 (extreme problems or inability). The EuroQol Visual Analogue Scale (EQ VAS) will also be used.
Measured: 12 weeks
Change in Hand Grip Strength
Significant increase in hand grip strength (kg). Higher hand grip strength is correlated with higher functional status. Maximum handgrip strength will be measured with the Lafayette Digital and Dynamometer 5030D1 manual digital dynamometer on the dominant upper limb.
Measured: 12 weeks
Change in Weight
Significant decrease in weight (kg). Higher values of weight mean poor body composition and health. The weight will be measured using the bioimpedance technique.
Measured: 12 weeks
Change in body mass index
Significant decrease in body mass index (kg/m2). Higher values of body mass index mean poor body composition and health. The body mass index will be measured using the bioimpedance technique.
Measured: 12 weeks
Change in fat mass
Significant decrease in fat mass (kg and %)). Higher values of fat mass mean poor body composition and health. The fat mass will be measured using the bioimpedance technique.
Measured: 12 weeks
Change in fat-free mass
Significant increase in fat-free mass (kg and %). Higher values of fat-free mass mean better body composition and health. The fat-free mass will be measured using the bioimpedance technique.
Measured: 12 weeks
Change in fat mass index
Significant decrease in fat mass index (kg/m2). Higher values of fat mass index mean poor body composition and health. The fat mass index will be measured using the bioimpedance technique.
Measured: 12 weeks
Change in fat-free mass index
Significant increase in fat-free mass index (kg/m2). Higher values of fat-free mass index mean better body composition and health. The fat-free mass index will be measured using the bioimpedance technique.
Measured: 12 weeks
Change in muscle mass index
Significant increase in muscle mass index (kg/m2). Higher values of muscle mass index mean better body composition and health. The muscle mass index will be measured using the bioimpedance technique.
Measured: 12 weeks
Monitoring phase angle
Keep the phase angle within normal limits for the age. The phase angle will be measured using the bioimpedance technique.
Measured: 12 weeks
Change in fat visceral fat
Significant decrease in visceral fat (L). Higher values of visceral fat mean poor body composition and health. The visceral fat will be measured using the bioimpedance technique.
Measured: 12 weeks
Change in abdominal circumference
Significant decrease in abdominal circumference (cm). Higher values of abdominal circumference mean poor body composition and health. The abdominal circumference will be measured using measure tape, according to the STEPS Manual of the World Health Organization.
Measured: 12 weeks
Changes in Total cholesterol (mg/dL) - Lipid Profile
Total cholesterol (mg/dL) will be measured taking a sample blood which will be analysed by the COBAS b 101 system.
Measured: 12 weeks
Changes in Triglycerides (mg/dL) - Lipid Profile
Triglycerides (mg/dL) will be measured taking a sample blood which will be analysed by the COBAS b 101 system.
Measured: 12 weeks
Changes in High-density lipoprotein (HDL) cholesterol (mg/dL) - Lipid Profile
High-density lipoprotein (HDL) cholesterol (mg/dL) will be measured taking a sample blood which will be analysed by the COBAS b 101 system.
Measured: 12 weeks
Changes in Low-density lipoprotein (HDL) cholesterol (mg/dL) - Lipid Profile
Low-density lipoprotein (HDL) cholesterol (mg/dL) will be measured taking a sample blood which will be analysed by the COBAS b 101 system.
Measured: 12 weeks
Changes in Glicemic Profile (HbA1c)
Glicemic Profile will be measured by COBAS b 101 system, taking a sample blood which will be analysed for Glycated Hemoglobin (HbA1c).
Measured: 12 weeks
Change in contraction time of bíceps femoris, tibial anterior and lateral gastrocnemius bi-lateral
Significant decrease in contraction time (ms) of bíceps femoris, tibial anterior and lateral gastrocnemius. Higher contraction time means poor muscle function. The contraction time will be measured by a tensiomyography system TMG S2. Tensiomyography assesses contractile properties of an isolated muscle by measuring a few parameters in response to a twitch contraction.
Measured: 12 weeks
Change in radial muscle belly displacement of bíceps femoris, tibial anterior and lateral gastrocnemius bi-lateral
Significant decrease in radial muscle belly displacement (mm) of bíceps femoris, tibial anterior and lateral gastrocnemius. Higher radial muscle belly displacement means poor muscle function and muscle atrophy. The radial muscle belly displacement will be measured by a tensiomyography system TMG S2. Tensiomyography assesses contractile properties of an isolated muscle by measuring a few parameters in response to a twitch contraction.
Measured: 12 weeks
Change in latence time of bíceps femoris, tibial anterior and lateral gastrocnemius bi-lateral
Significant decrease in latence time (ms) of bíceps femoris, tibial anterior and lateral gastrocnemius. Higher latence time means poor muscle function. The latence time will be measured by a tensiomyography system TMG S2.
Tensiomyography assesses contractile properties of an isolated muscle by measuring a few parameters in response to a twitch contraction.
Measured: 12 weeks
Change in bone mineral density (BMD)
Significant increase in bone mineral density (BMD) (g/cm2) and improvement in T-score and Z-score. A higher BMD indicates reduced bone fragility. BMD will be assessed using a Radiofrequency Echographic Multi-Spectrometry (REMS) device at the lumbar spine and femoral neck.
Measured: 12 weeks
Change in Osteoarthritis (OA) Symptoms and Function
A significant reduction in osteoarthritis (OA) symptoms and an improvement in physical function are expected. Symptoms and disability in knee and hip OA will be assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC), which comprises pain, stiffness, and physical function subscales. Each item is scored on a scale from 0 to 4, with lower scores indicating fewer symptoms and better functional status.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study startOct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned for two groups in parallel and a pre and post-test analysis is performed.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associação para o Desenvolvimento do Centro Académico de Investigação e Formação Biomédica do Algarv
- Sponsor type
- Research network
- Collaborators
- Loulé Municipal Council, Albufeira Municipal Council, Universidade do Algarve
- Responsible party
- Principal investigator, Marta Cristina Soares Botelho, Associação para o Desenvolvimento do Centro Académico de Investigação e Formação Biomédica do Algarv
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771024
- Sponsor's protocol ID
- CPEP-Chronic Disease
- Acronym
- CPEPCD
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Community Physical Exercise Program in Chronic Disease (CPEP - Chronic Disease), a Clinical Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06771024
- Acronym / sponsor ID
- CPEPCD / CPEP-Chronic Disease
- Conditions
- Osteoarthritis Pain, Myocardial Infarction (MI), Hypertension, Dyslipidemia, Diabetes Mellitus, Overweight , Obesity
- Keywords
- Physical Exercise Program, Healthy Ageing, Cardiovascular Risk, Osteoarthritis, Multimorbility, Chronic Diseases, Diabetes Mellitus, Cerebrovascular risk
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Associação para o Desenvolvimento do Centro Académico de Investigação e Formação Biomédica do AlgarvResearch network
- Collaborators
- Loulé Municipal Council, Albufeira Municipal Council, Universidade do Algarve
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study focuses on promoting physical activity (PA) through the implementation of a Community Physical Exercise Program for Chronic Diseases (CPEP-CD), targeting individuals aged 50 years and older with at least two of the following conditions: cardiovascular and/or cerebrovascular disease or risk (CVD), overweight, diabetes mellitus (DM), and musculoskeletal diseases. The primary objective is to improve muscle and cardiorespiratory health and well-being, while also contributing to a more objective and evidence-based exercise prescription for these pathological conditions.
Population ageing is a global challenge associated with an increased prevalence of chronic diseases that compromise quality of life (QoL). A sedentary lifestyle is linked to declines in muscle function and cardiorespiratory fitness and is considered a major risk factor for morbidity and mortality. Consequently, physical exercise is widely recommended as a key non-pharmacological intervention across multiple chronic diseases.
According to World Health Organization (WHO) guidelines, regular PA is a protective factor in the prevention and management of non-communicable diseases, including cardiovascular and cerebrovascular diseases and DM. In addition, PA provides mental health benefits, supports healthy weight maintenance, and enhances overall well-being. In adults, regular PA is associated with reductions in all-cause mortality, cardiovascular mortality, and the incidence of hypertension.
Within this context, the aim of this project is to implement a community-based physical exercise program for individuals with chronic disease and multimorbidity, focusing on CVD and cerebrovascular disease or risk, DM, and OA. The program integrates existing exercise prescription guidelines while personalizing exercise progression according to both disease-specific and multimorbidity profiles. The primary outcomes include improvements in cardiorespiratory fitness, muscular strength, bone health, functional capacity, and QoL. Additionally, through individualized training monitoring, this study seeks to establish an exercise prescription tailored to the most prevalent combinations of chronic diseases, thereby providing more objective and practical guidance for family physicians, exercise professionals, and rehabilitation specialists, and supporting more personalized and targeted exercise-based strategies for chronic disease prevention and management.
Detailed description
The implementation of exercise programs in individuals with chronic disease is essential for modifying cardiovascular and metabolic risk factors. However, it is equally important to examine not only the direct effects of exercise on health and well-being outcomes, but also to quantify the most appropriate training load, particularly in the presence of multimorbidity.
This is a non-pharmacological clinical study with two parallel intervention groups and a pre-post study design. Participants allocated to the Exercise Group (EG) will undertake a 12-week supervised physical exercise program, while those in the Control Group (CG) will receive no intervention during the study period.
Both groups will be assessed at two time points: (1) baseline assessment (T0) and (2) post-intervention assessment after 12 weeks (T12). The Community Physical Exercise Program (CPEP) will last 12 weeks, with two sessions per week, each lasting 60 minutes. International and national exercise prescription guidelines will be applied for each clinical condition, namely cardiovascular and/or cerebrovascular disease or risk, diabetes mellitus, and osteoarthritis. All variables will be assessed and monitored by qualified health and exercise professionals using reliable and validated instruments and equipment.
The training sessions will combine cardiorespiratory exercises aimed at improving aerobic capacity with strength training, particularly resistance exercises, using body weight and auxiliary equipment. Training intensity zones will be individualized and defined according to each participant's baseline cardiorespiratory fitness test results and subjective perception of effort.
The sample will include individuals aged 50 years or older with at least one of the aforementioned chronic conditions. Participation will be voluntary, and recruitment will be conducted through dissemination materials placed in senior universities, institutions and associations, municipalities, parish councils, sports facilities, health centers, and other relevant public spaces.
The sampling process will consist of an initial phase of non-random purposive sampling, followed by a second phase using snowball sampling if necessary. Sample size was calculated using G*Power software (version 3.1.9.7), assuming a two-tailed α level of 0.05, an effect size of 0.5, statistical power of 80%, and an anticipated dropout rate of 15%. A total sample of 147 participants will be required, with 74 participants allocated to each group.
Cardiovascular risk screening will be conducted based on the presence of one or more of the following risk factors: hypertension, dyslipidemia, or smoking, in accordance with SCORE2 or SCORE2-OP. For the other pathological conditions, definitions and criteria will be used in accordance with the recommendations of European or American scientific societies.
Following the intervention, the expected outcomes include improvements in cardiorespiratory fitness, muscular strength and muscle function, bone health, joint pain, physical function, quality of life, biochemical parameters related to glycemic and lipid profiles, and body composition. Additionally, the study aims to quantify the average training load and its progression over the intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned for two groups in parallel and a pre and post-test analysis is performed.
| Arm | Type | Receives |
|---|---|---|
| Community Physical Exercise Program Group | Experimental | Behavioral: Physical ExerciseThe participants receive a twelve weeks of a supervised physical exercise program, based on aerobic and strength training. |
| Control Group | No intervention | –Participants do not receive any intervention. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged ≥50 years;
- At least 2 of the following: Prior cardiovascular disease (>12 months); High cardiovascular risk (SCORE2 or SCORE2 O.P.); Post-stroke (ischemic or hemorrhagic) with treated etiology; Type 2 Diabetes (> 6 months, ADA); Osteoarthristis (clinical signs/symptoms, NICE); Overweight/Obesity (BMI ≥ 27 kg/m2).
- Autonomous walking.
- Able to provide informed consent.
- Stable medications for ≥ 3 months (related to diagnoses of interest).
Key exclusion criteria (14 listed)
- Moderate to severe cognitive impairment - Montreal Cognitive Assessment (MoCA).
- Type 2 Myocardial Infarction.
- Class III or IV angina (Canadian Cardiovascular Society).
- Class III or IV angina (New York Heart Association).
- Uncontrolled CVD: symptomatic arrhythmias with hemodynamic compromise; severe symptomatic aortic valve stenosis; uncontrolled symptomatic heart failure; endocarditis, pericarditis, or active myocarditis; acute aortic syndrome; suspected or known dissecting aneurysm; acute systemic infections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ExerciseThe intervention include a personalized physical exercise program based on aerobic and strength training, with prior warm-up and post cool-down exercises. International/national exercise prescription guidelines will be applied for each clinical condition (cardio/cerebrovascular disease/risk, diabetes mellitus and osteoarthritis). The main exercise component consists of concurrent training, combining resistance and aerobic exercises. The aims are to enhance muscle strength and endurance, improve self-confidence, increase the ability to perform activities of daily living, maintain independence, and reduce cardiac demands during daily activities (as indicated by a lower heart rate-pressure product). Training intensity is monitored using heart rate (HR) sensors. Blood pressure, HR, peripheral oxygen saturation (SpO₂), perceived exertion (Modified Borg Scale - MBS), and other relevant events are recorded in a daily log. | Behavioural | Community Physical Exercise Program Group |
Primary outcome
Change in Peak Oxygen Uptake (VO2peak)
Time frame: 12 weeks
Significant increase in Peak Oxygen Uptake (VO2peak). Higher VO2peak means better cardiorespiratory function. The VO2peak will be evaluated through the exercise cardiorespiratory test with progressive increase of the external load in a cycle ergometer.
Change in First Ventilatory Threshold (VT1 - VO2)
Time frame: 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 in a cycle ergometer.
Change in Respiratory Compensation Point (RCP - VO2)
Time frame: 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 in a cycle ergometer.
Change in peak torque of quadriceps and hamstring muscles
Time frame: 12 weeks
A significant increase in peak torque (N/m). Peak torque of the quadriceps and hamstring muscles will be measured using a fixed dynamometer with concentric-concentric actions at an angular velocity of 60° per second, during five maximal repetitions of knee extension and flexion for each knee.
Change in work of quadriceps and hamstring muscles
Time frame: 12 weeks
A significant increase in work per repetition (N/m). Work of the quadriceps and hamstring muscles will be measured using a fixed dynamometer with concentric-concentric actions at an angular velocity of 60° per second, during five maximal repetitions of knee extension and flexion for each knee.
Change in power of quadriceps and hamstring muscles
Time frame: 12 weeks
A significant increase in power per repetition (W). Peak torque of the quadriceps and hamstring muscles will be measured using a fixed dynamometer with concentric-concentric actions at an angular velocity of 60° per second, during five maximal repetitions of knee extension and flexion for each knee.
25 secondary outcomes
Change in lower limb functionality (number of repetions)
Time frame: 12 weeks
Change in functional mobility (seconds)
Time frame: 12 weeks
Change in Oscillation of the Center of Pressure
Time frame: 12 weeks
Change in Health-Related Quality of Life
Time frame: 12 weeks
Change in Hand Grip Strength
Time frame: 12 weeks
Change in Weight
Time frame: 12 weeks
Change in body mass index
Time frame: 12 weeks
Change in fat mass
Time frame: 12 weeks
Change in fat-free mass
Time frame: 12 weeks
Change in fat mass index
Time frame: 12 weeks
Change in fat-free mass index
Time frame: 12 weeks
Change in muscle mass index
Time frame: 12 weeks
Monitoring phase angle
Time frame: 12 weeks
Change in fat visceral fat
Time frame: 12 weeks
Change in abdominal circumference
Time frame: 12 weeks
Changes in Total cholesterol (mg/dL) - Lipid Profile
Time frame: 12 weeks
Changes in Triglycerides (mg/dL) - Lipid Profile
Time frame: 12 weeks
Changes in High-density lipoprotein (HDL) cholesterol (mg/dL) - Lipid Profile
Time frame: 12 weeks
Changes in Low-density lipoprotein (HDL) cholesterol (mg/dL) - Lipid Profile
Time frame: 12 weeks
Changes in Glicemic Profile (HbA1c)
Time frame: 12 weeks
Change in contraction time of bíceps femoris, tibial anterior and lateral gastrocnemius bi-lateral
Time frame: 12 weeks
Change in radial muscle belly displacement of bíceps femoris, tibial anterior and lateral gastrocnemius bi-lateral
Time frame: 12 weeks
Change in latence time of bíceps femoris, tibial anterior and lateral gastrocnemius bi-lateral
Time frame: 12 weeks
Change in bone mineral density (BMD)
Time frame: 12 weeks
Change in Osteoarthritis (OA) Symptoms and Function
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Exercise in people with Osteoarthritis Pain and Myocardial Infarction (MI), run by Associação para o Desenvolvimento do Centro Académico de Investigação e Formação Biomédica do Algarv at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta S Botelho, PhD in Health of Sciences (+351 916785430, marta.botelho@abcmedicalg.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peak Oxygen Uptake (VO2peak) (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.