Community Physical Exercise Program in Chronic Disease

Not Applicable

• Conditions: Hypertension; Myocardial Infarction (MI); Osteoarthritis Pain; Type 2 Diabetes Mellitus (T2DM); Dyslipidemia

• Registration Number: NCT06771024
• Lead Sponsor: Associação para o Desenvolvimento do Centro Académico de Investigação e Formação Biomédica do Algarv

Brief Summary

This study focuses on promoting the practice of Physical Activity (PA) through the implementation of a Community Physical Exercise Program (CPEP) in chronic disease, particularly in individuals aged 50 years and over with cardio/cerebrovascular disease/risk (CVD), diabetes mellitus (DM) and musculoskeletal diseases with a focus on osteoarthritis (OA), with the main objective of improving levels of health and well-being. This program is also intended to contribute to a more objective exercise prescription in these pathological conditions.

Population ageing is a worldwide problem that results in a prevalence increase in of chronic diseases that compromise Quality of Life (QoL). A sedentary lifestyle is associated with a decline in muscle function and cardiorespiratory condition, being considered the main risk factor for mortality and morbidity. The practice of physical exercise is recommended as one of the main non-pharmacological approaches common to different chronic diseases.

According to the guidelines of the World Health Organization (WHO), the practice of regular PA is identified as a protective factor for the prevention and management of non-transmissible diseases, such as CVD, cerebrovascular diseases and DM and has benefits for mental health, can contribute to maintaining a healthy weight and general well-being. In adults, PA confers benefits on health outcomes such as decreased all-cause mortality, CVD mortality and incidence of hypertension.

In this context, the goal of this project is to implement a PCEF in chronic disease and multimorbidity, focusing on cardio and cerebrovascular disease/risk, DM and OA, implementing existing exercise prescription guidelines and simultaneously personalizing the evolution of the exercise program not only according to the disease. This study aims primarily to improve people's cardiorespiratory capability, muscular strength, functionality and QoL, but also through personalized training monitoring to establish an exercise prescription adjusted to the multimorbidity of the most prevalent chronic diseases, which will allow us to provide more objective guidance to family doctors, training and rehabilitation professionals, ensuring a more personalized and targeted exercise prescription for the prevention of chronic disease.

Detailed Description

The implementation of exercise programs in chronic disease is important as a means of modifying risk factors, however it is essential to study not only the direct effects of exercise on health and well-being outcomes, but also to quantify the load that it is most appropriate considering multimorbidity.

This is a non-pharmacological clinical study that includes 2 parallel intervention groups with a pre- and post-test analysis. In the Community Program Group (CP_Group), the participants received a 12 weeks of a supervised physical exercise program and in the control group (C_Group) there was no intervention.

The two groups are assessed two times: 1) Baseline Assessment (T0); 2) Assessment after 12 weeks of the program (T12). The CPEP consists of 12 weeks, with 2 weekly sessions and each session lasting 60 minutes. International/national exercise prescription guidelines will be applied for each clinical condition (cardio/cerebrovascular disease/risk, diabetes mellitus and osteoarthritis). All variables will be assessed and monitored using reliable and validated equipment and instruments by health and exercise professionals.

The training sessions combine cardiorespiratory exercises for the development of aerobic capacity and strength exercises, particularly resistant strength, using your own body weight and auxiliary equipment. The training zones are defined according to the performance of each individual in the test of cardiorespiratory capability and subjective perception of effort, carried out in the baseline.

The sample includes subjects aged 50 years with at least one of the diseases indicated above. Participation in the study was voluntary and sample recruitment was carried out through publicity materials posted at senior universities, institutions/associations, municipalities, parish councils, sports complexes, health centres, among other public spaces of interest.

The sampling process will consist of a first phase of non-random sampling of the intentional type, and in a second phase the sampling process may be carried out using the snowball type. To calculate the minimum sample size, the G\*Power software was used. Based on the standardized value of the effect size determined by the meta-analysis of Huang et al, for the VO2max variable of 0.64, α = 5%, power of 80% and two groups, a sample size of 40 people was calculated for each group.

The screening of cardiovascular risk was done with the presence of any of the following cardiovascular risk factors: hypertension, dyslipidemia, or smoking habits, according to the SCORE2 or SCORE2 O.P. The screening of osteoarthritis was done according to the National Clinical Guideline Centre (2020) criteria. The inclusion of people with Diabetes in this study is carried out in accordance with Norm nº 002/2011 of the General Health Department in Portugal.

After the exercise program, it is expected to achieve the following results: Improve cardiorespiratory capacity, strength levels and muscular response; Improve the level of joint pain and improve physical function; Improve quality of life; Improve biochemical parameters associated with the glycaemic and lipid profile; Improve body composition parameters; and quantify the average training load and its progression.

Study Timeline

• Study Start: 2024-05-03
• Status Verified: 2025-01
• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• 50 or more years old;
• The current amount of physical activity does not correspond to WHO recommendations (<150 min of moderate-intensity physical activity/week or <75 min of vigorous-intensity physical activity/week);
• No cardio/cerebrovascular, respiratory and musculoskeletal contraindications to physical exercise, according to ACSS;
• Independent gait AND
• High risk level in SCORE2 or SCORE2 O.P. cardiovascular risk algorithm or prior cardiovascular disease; AND/OR
• Post Stroke ischemic or hemorrhagic type with a defined and treated etiology. AND/OR
• Type 2 DM diagnosed at least 6 months ago; AND/OR
• Clinical diagnosis of osteoarthritis (OA) according to National Institute for Health and Care Excellence (NICE) guidelines.

Exclusion Criteria

• Cognitive impairment- Montreal Cognitive Assessment (MoCA);
• Participation in supervised dietary intervention;
• Occurrence of acute myocardial infarction with less than 12 months;
• 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;
• Presence of neurological disorders that influence gait;
• Major complications of DM that does not allow exercise practice (poor metabolic control, diabetic foot, diabetic retinopathy, diabetic nephropathy and diabetic autonomic neuropathy);
• Taking insulin or sulphonylureas for less than three months;
• Pacemaker device;
• Internal prosthesis;
• Untreated stroke etiology: indication for revascularization; non-hypocagulated atrial fibrillation, intracranial atheromatous occlusive disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Maximal Oxygen Uptake (VO2max)	12 weeks	Significant increase in Maximal Oxygen Uptake (VO2max). Higher VO2max means better cardiorespiratory function. The VO2max was 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)	12 weeks	Significant increase in Respiratory Compensation Point (RCP - VO2). Higher RCP means better cardiorespiratory function. The RCP was 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)	12 weeks	Significant increase in First Ventilatory Threshold (VT1 - VO2). Higher VT1 means better cardiorespiratory function. The VT1 was evaluated through the exercise cardiorespiratory test with progressive increase of the external load by the manipulation of the velocity or inclination.
Change in Peak Torque of Quadriceps and Hamstring Muscles	12 weeks	Significant increase in peak torque (N/m). Peak Torque of Quadriceps and Hamstring Muscles was 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	12 weeks	Significant increase in power per repetition (N/m). Power of Quadriceps and Hamstring Muscles was 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	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 the Time Up and Go Test Performance	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 in Quality of Life	12 weeks	Significant increase in score of EQ-5D-5L and EQ-VAS instruments, used to assess quality of life. EQ-5D-5L index can range between 0-1 and higher values mean better selfprecepted quality of life. EQ-VAS can range between 0-100 and higher values mean better selfprecepted quality of life.
Change in pain associated with osteoarthritis	12 weeks	Pain associated with osteoarthritis was mesured by Western Ontario and McMaster Universities Arthritis Index (WOMAC Index) - subscore pain. This instrument is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items), and Physical Function (17 items). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Higher scores indicate worse pain, stiffness, and functional limitations.
Change in Physical Function associated with osteoarthritis	12 weeks	Physical Function associated with osteoarthritis was mesured by Western Ontario and McMaster Universities Arthritis Index (WOMAC Index) - subscore Physical Function. This instrument is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items), and Physical Function (17 items). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Higher scores indicate worse pain, stiffness, and functional limitations.

Secondary Outcome Measures

Name	Time	Method
Change in Work of Quadriceps and Hamstring Muscles	12 weeks	Significant increase in work per repetition (N/m). Work of Quadriceps and Hamstring Muscles was 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	12 weeks	Significant increase in Peak torque time (s). Peak torque time of Quadriceps and Hamstring Muscles was 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	12 weeks	Significant increase in Force (kg). Force of Quadriceps and Hamstring Muscles was 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 Hand Grip Strength	12 weeks	Significant increase in hand grip strength (kg). Higher hand grip strength is correlated with higher functional status. Maximum handgrip strength was measured with the Lafayette Digital and Dynamometer 5030D1 manual digital dynamometer on the dominant upper limb.
Change in Oscillation of the Center of Pressure	12 weeks	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).
Changes in Total cholesterol (mg/dL) - Lipid Profile	12 weeks	Total cholesterol (mg/dL) was measured taking a sample blood which was analysed by the COBAS b 101 system.
Changes in Triglycerides (mg/dL) - Lipid Profile	12 weeks	Triglycerides (mg/dL) was measured taking a sample blood which was analysed by the COBAS b 101 system.
Changes in High-density lipoprotein (HDL) cholesterol (mg/dL) - Lipid Profile	12 weeks	High-density lipoprotein (HDL) cholesterol (mg/dL) was measured taking a sample blood which was analysed by the COBAS b 101 system.
Changes in Low-density lipoprotein (HDL) cholesterol (mg/dL) - Lipid Profile	12 weeks	Low-density lipoprotein (HDL) cholesterol (mg/dL) was measured taking a sample blood which was analysed by the COBAS b 101 system.
Changes in Glicemic Profile	12 weeks	Glicemic Profile was measured by COBAS b 101 system, taking a sample blood which was analysed for Glycated Hemoglobin (HbA1c).
Change in Weight	12 weeks	Significant decrease in weight (kg). Higher values of weight mean poor body composition and health. The weight was measured using the bioimpedance technique.
Change in body mass index	12 weeks	Significant decrease in body mass index (kg/m2). Higher values of body mass index mean poor body composition and health. The body mass index was measured using the bioimpedance technique.
Change in fat mass	12 weeks	Significant decrease in fat mass (kg and %)). Higher values of fat mass mean poor body composition and health. The fat mass was measured using the bioimpedance technique.
Change in fat-free mass	12 weeks	Significant increase in fat-free mass (kg and %). Higher values of fat-free mass mean better body composition and health. The fat-free mass was measured using the bioimpedance technique.
Change in fat mass index	12 weeks	Significant decrease in fat mass index (kg/m2). Higher values of fat mass index mean poor body composition and health. The fat mass index was measured using the bioimpedance technique.
Change in fat-free mass index	12 weeks	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 was measured using the bioimpedance technique.
Change in muscle mass index	12 weeks	Significant increase in muscle mass index (kg/m2). Higher values of muscle mass index mean better body composition and health. The muscle mass index was measured using the bioimpedance technique.
Monitoring phase angle	12 weeks	Keep the phase angle within normal limits for the age. The phase angle was measured using the bioimpedance technique.
Change in fat visceral fat	12 weeks	Significant decrease in visceral fat (L). Higher values of visceral fat mean poor body composition and health. The visceral fat was measured using the bioimpedance technique.
Change in abdominal circumference	12 weeks	Significant decrease in abdominal circumference (cm). Higher values of abdominal circumference mean poor body composition and health. The abdominal circumference was measured using measure tape, according to the STEPS Manual of the World Health Organization.
Change in contraction time of bíceps femoris, tibial anterior and lateral gastrocnemius bi-lateral	12 weeks	Significant decrease in contraction time (ms) of bíceps femoris, tibial anterior and lateral gastrocnemius. Higher contraction time means poor muscle function. The contraction time was 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.
Change in radial muscle belly displacement of bíceps femoris, tibial anterior and lateral gastrocnemius bi-lateral	12 weeks	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 was 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.
Change in latence time of bíceps femoris, tibial anterior and lateral gastrocnemius bi-lateral	12 weeks	Significant decrease in latence time (ms) of bíceps femoris, tibial anterior and lateral gastrocnemius. Higher latence time means poor muscle function. The latence time was 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.

Trial Locations

Locations (1)

Algarve Biomedical Center; 🇵🇹 Faro, Algarve, Portugal