Community Physical Exercise Program in Chronic Disease

NCT ID: NCT06771024

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-03
• Study Completion Date: 2025-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Community Program Group

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

Group Type: EXPERIMENTAL

Physical Exercise

Intervention Type: 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).

Control Group

Participants do not receive any intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physical Exercise

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loulé Municipal Council

UNKNOWN

Sponsor Role: collaborator

Albufeira Municipal Council

UNKNOWN

Sponsor Role: collaborator

Quarteira Parish Council

UNKNOWN

Sponsor Role: collaborator

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

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Algarve Biomedical Center

Faro, Algarve, Portugal

Countries

Portugal

Other Identifiers

CPEP-Chronic Disease

Identifier Type: -

Identifier Source: org_study_id