Clinical trial NCT06771024: Community Physical Exercise Program in Chronic Disease
Official title: Community Physical Exercise Program in Chronic Disease - Impact on Cardiorespiratory Capability, Muscle Strength, Functionality and Quality of Life
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Type 2 Diabetes Mellitus (T2DM)
Osteoarthritis Pain
Myocardial Infarction (MI)
Hypertension
Dyslipidemia
Keywords: Physical Exercise Program
Healthy Ageing
Cardiovascular Risk
Type 2 Diabetes
Osteoarthritis
Lead sponsor: Associação para o Desenvolvimento do Centro Académico de Investigação e Formação Biomédica do Algarv
Sponsor class: NETWORK
Collaborators: name: Loulé Municipal Council
name: Albufeira Municipal Council
name: Quarteira Parish Council
First posted: 2025-01-13
Enrollment: 240
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned for two groups in parallel and a pre and post-test analysis is performed.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Maximal Oxygen Uptake (VO2max)
timeFrame: 12 weeks
measure: Change in First Ventilatory Threshold (VT1 - VO2)
timeFrame: 12 weeks
measure: Change in Respiratory Compensation Point (RCP - VO2)
timeFrame: 12 weeks
measure: Change in Peak Torque of Quadriceps and Hamstring Muscles
timeFrame: 12 weeks
measure: Change in Power of Quadriceps and Hamstring Muscles
timeFrame: 12 weeks
measure: Change the 30-Second Chair Stand Test Performance
timeFrame: 12 weeks
measure: Change the Time Up and Go Test Performance
timeFrame: 12 weeks
measure: Change in Quality of Life
timeFrame: 12 weeks
measure: Change in pain associated with osteoarthritis
timeFrame: 12 weeks
measure: Change in Physical Function associated with osteoarthritis
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Work of Quadriceps and Hamstring Muscles
timeFrame: 12 weeks
measure: Change in Peak torque time of Quadriceps and Hamstring Muscles
timeFrame: 12 weeks
measure: Change in Force of Quadriceps and Hamstring Muscles
timeFrame: 12 weeks
measure: Change in Hand Grip Strength
timeFrame: 12 weeks
measure: Change in Oscillation of the Center of Pressure
timeFrame: 12 weeks
measure: Changes in Total cholesterol (mg/dL) - Lipid Profile
timeFrame: 12 weeks
measure: Changes in Triglycerides (mg/dL) - Lipid Profile
timeFrame: 12 weeks
measure: Changes in High-density lipoprotein (HDL) cholesterol (mg/dL) - Lipid Profile
timeFrame: 12 weeks
measure: Changes in Low-density lipoprotein (HDL) cholesterol (mg/dL) - Lipid Profile
timeFrame: 12 weeks
measure: Changes in Glicemic Profile
timeFrame: 12 weeks
measure: Change in Weight
timeFrame: 12 weeks
measure: Change in body mass index
timeFrame: 12 weeks
measure: Change in fat mass
timeFrame: 12 weeks
measure: Change in fat-free mass
timeFrame: 12 weeks
measure: Change in fat mass index
timeFrame: 12 weeks
measure: Change in fat-free mass index
timeFrame: 12 weeks
measure: Change in muscle mass index
timeFrame: 12 weeks
measure: Monitoring phase angle
timeFrame: 12 weeks
measure: Change in fat visceral fat
timeFrame: 12 weeks
measure: Change in abdominal circumference
timeFrame: 12 weeks
measure: Change in contraction time of bíceps femoris, tibial anterior and lateral gastrocnemius bi-lateral
timeFrame: 12 weeks
measure: Change in radial muscle belly displacement of bíceps femoris, tibial anterior and lateral gastrocnemius bi-lateral
timeFrame: 12 weeks
measure: Change in latence time of bíceps femoris, tibial anterior and lateral gastrocnemius bi-lateral
timeFrame: 12 weeks
Other outcomes:
measure: Monitoring Diabetic Peripheral Neuropathy -DPN
timeFrame: 0
Locations:
city: Faro
country: Portugal
facility: Algarve Biomedical Center
state: Algarve
Study officials:
References: