Community Physical Exercise Program in Chronic Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorAssociação para o Desenvolvimento do Centro Académico de Investigação e Formação Biomédica do Algarv

About this 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.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Community Physical Exercise Program GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
12 weeks
2

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.

Time frame
12 weeks
3

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.

Time frame
12 weeks
4

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.

Time frame
12 weeks

Secondary outcomes

1

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).

Time frame
12 weeks
2

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.

Time frame
12 weeks
3

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).

Time frame
12 weeks
4

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.

Time frame
12 weeks

Other outcomes

1

Monitoring Diabetic Peripheral Neuropathy -DPN

To assess the presence and level of severity of DPN, the Michigan Neuropathy Screening Instrument (MNSI) will be used. The MNSI is divided into two parts: questionnaire (Q) and physical examination (FE). The following cutoffs are used at Q-MNSI ≥ 4.0 and/or at EF-MNSI ≥ 2.5.

Time frame
0

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Associação para o Desenvolvimento do Centro Académico de Investigação e Formação Biomédica do Algarv

Lead sponsor

Loulé Municipal Council

Collaborator

Albufeira Municipal Council

Collaborator

Universidade do Algarve

Collaborator

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