Community Physical Exercise Program in Chronic Disease

NCT06771024 | Not Yet Recruiting

• 1 other identifier: CPEP-Chronic Disease
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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), 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.

Conditions

Osteoarthritis Pain; Myocardial Infarction (MI); Hypertension; Dyslipidemia; Diabetes Mellitus; Overweight , Obesity; Stroke

Keywords

Physical Exercise Program; Healthy Ageing; Cardiovascular Risk; Osteoarthritis; Multimorbility; Chronic Diseases; Diabetes Mellitus; Cerebrovascular risk

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  12 weeks

Secondary Outcomes (25)

• Change in lower limb functionality (number of repetions)

  12 weeks

• Change in functional mobility (seconds)

  12 weeks

• Change in Oscillation of the Center of Pressure

  12 weeks

• Change in Health-Related Quality of Life

  12 weeks

• Change in Hand Grip Strength

  12 weeks

Other Outcomes (1)

• Monitoring Diabetic Peripheral Neuropathy -DPN

  0

Study Arms (2)

Community Physical Exercise Program Group

EXPERIMENTAL

The participants receive a twelve weeks of a supervised physical exercise program, based on aerobic and strength training.

Behavioral: Physical Exercise

Control Group

NO INTERVENTION

Participants do not receive any intervention.

Interventions

Physical Exercise BEHAVIORAL

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.

Community Physical Exercise Program Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Loulé Municipal Council: collaborator
• Albufeira Municipal Council: collaborator
• Universidade do Algarve: collaborator
• Associação para o Desenvolvimento do Centro Académico de Investigação e Formação Biomédica do Algarv: lead

Study Sites (1)

Algarve Biomedical Center

Faro, Algarve, 8005-139, Portugal

Location

MeSH Terms

Conditions

Myocardial Infarction; Hypertension; Dyslipidemias; Diabetes Mellitus; Overweight; Obesity; Stroke; Osteoarthritis; Chronic Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

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; Glucose Metabolism Disorders; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Disease Attributes

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Marta S Botelho, PhD in Health of Sciences

CONTACT

+351 916785430; marta.botelho@abcmedicalg.pt

Carla P Guerreiro, PhD in Health Sciences

CONTACT

+351 964475648; carla.guerreiro@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: Assistant Researcher

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

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 13, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-01

Locations

PT (1)