COPDNCT06476015
Effectiveness of Physical Exercise of Patients With Chronic Non-communicable Disease
An observational study of COPD and Diabetes, run by Fundacion Universitaria Maria Cano at 1 site in Colombia.
Trial summary
According to the Pan American Health Organization (PAHO), chronic, non-communicable diseases (NCDs) are the main cause of death and disability in the world. The term, NCD refers to a group of diseases that are not primarily caused by acute infection and result in long-lasting health consequences, with significant… Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- COPD, Diabetes, Physical Inactivity
- What is being tested?
- Therapeutic exercise
- How many people
- 300 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jan 2024to 30 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and women, between 60 and 90 years old, residents in the metropolitan area, with a diagnosis of COPD and/or diabetes who entered the NCD patient care program called "Ser más".
Who may be able to join
- Records between 2018 and 2023
- Men and women, between 60 and 90 years old.
- Clinical diagnosis of COPD and/or diabetes.
- Must be patient from program called "Ser más".
Who cannot join
- Records containing incomplete data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
Fundación Universitaria María cano
Medellín, Antioquia, 05000
catalina Lopera, Msc, +57 3206728934, catalinaloperamuneton@fumc.edu.co
About this study
Official title: Effectiveness of Physical Exercise on Frailty, Body Composition and Functional Classification of Patients With Chronic Non-communicable Disease
According to the Pan American Health Organization (PAHO), chronic, non-communicable diseases (NCDs) are the main cause of death and disability in the world. The term, NCD refers to a group of diseases that are not primarily caused by acute infection and result in long-lasting health consequences, with significant long-term care and treatment needs. These include chronic lung diseases such as COPD and metabolic diseases such as Diabetes. Worldwide, chronic non-communicable diseases are related to physical inactivity as the main risk factor. In this sense, exercise and physical activity have become priority elements of public health, with recommendations that they be carried out with moderate intensity at least 150 minutes a week. In Colombia, exercise as an important strategy for the prevention and management of chronic non-communicable diseases, which is described in the ten-year public health plan. However, in its application in clinical practice, the evidence shows that there are few structured programs at the national or regional level, which monitor the adequate prescription of exercise as a therapeutic strategy for the control of NCDs and improvement. of functionality. Reason for which this research arises, which aims to describe the effectiveness of exercise on the frailty, body composition and functional classification of 300 patients with chronic non-communicable disease.
Read the detailed description
Non-communicable diseases represent a significant burden on public health worldwide. These are the main cause of premature mortality and disability in the Americas and represent two thirds of all deaths in the region. Comprehensive understanding of the relationship between frailty, body composition, exercise (aerobic and strength) and diseases such as COPD and diabetes, is essential to develop effective preventive and therapeutic strategies. This can not only have an impact on the quality of life of affected individuals, but also in reducing the global burden of these diseases and their comorbidities.
In this sense, diabetes mellitus is a group of metabolic disorders that is characterized by chronic hyperglycemia, due to a defect in insulin secretion, a defect in insulin action, or both. In addition to hyperglycemia, alterations in fat and protein metabolism coexist. Sustained hyperglycemia over time is associated with damage, dysfunction and failure of several organs and systems, especially kidneys, eyes, nerves, heart and blood vessels. On the other hand, physical exercise has proven to be an effective intervention because it improves insulin sensitivity, facilitates glycemic control and reduces cardiovascular risk, also because it helps in managing body weight and improves quality of life in general.
On the other hand, COPD is a chronic respiratory pathological condition characterized by a persistent limitation of expiratory airflow that is partially reversible; It remains one of the main public health problems and is the fourth cause of mortality in the United States. It is known that, within the clinical manifestations or symptoms, there is an impact on the state of health, quality of life and daily activities, which contribute to an increase in levels of anxiety, depression, risk of exacerbations and a worse prognosis of the disease. Performing physical exercise in this population is of vital importance because it improves lung capacity and the efficiency of the cardiovascular system, improves exercise tolerance through strength and resistance training, which makes it easier to perform daily tasks due to to the reduction of symptoms such as dyspnea, reducing exacerbations and hospitalizations, which translates into a better quality of life.
Based on the previous problem, since 2017 the Alma Mater Clinic of Antioquia proposed a comprehensive care program for patients with chronic diseases called "Ser mas" Pluripathologicos, which includes 5,000 patients from the metropolitan area who live near the health center. . In 2021, they published their first study with the objective of evaluating the predictive validity of a classification method based on functional status, the presence of risk factors and the control of comorbidity, on the use of emergency services and hospitalization. , mortality and health care costs in older adults with NCDs. The results describe that functional capacity is an element that could inform and direct intervention actions in this population. Additionally, it suggests that objective measurements of functional status and the presence of frailty in patients with NCDs could be key elements to identify individuals with health needs and guide their interventions in an effective and individualized manner for their well-being. From the above, the current research arises, which aims to evaluate the effectiveness of physical exercise on the frailty, body composition and functional classification of patients with NCDs.
- Conditions
- COPD, Diabetes, Physical Inactivity, Frailty
- Being tested
- Therapeutic exercise
- Keywords
- COPD, Diabetes, Excercise, Frailty
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus, Sedentary Behavior, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exerciseOther
Duration: 30 minutes. Frequency: Once a week. Type of excercise: Cardiovascular, strengthening and balance. Supervised by a health professional.
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty
The data will be collected from the clinical registries which have included The Groeningen frailty test, walking speed test and single-leg support test. These variables were measured by groningen frailty indicator questionnaire. This scale categorizes patients with significant frailty when they obtain a score ≥ 4. In addition, the walking speed in 5 meters will also be taken into account, which is considered in fragility cut from 0.6 m/sec and the single-leg support time when it is < 10 seconds.
This outcome is compound by multiple measurements that will be aggregated to arrive at one reported.
Measured: 2018-2023
Secondary outcomes (2)
Body composition
The data will be collected from the clinical registries which have included anthropometric measurements such us Body mass index, skin folds (tricipital, abdominal and mid-thigh), waist and thigh circumference. Obesity is present when the sum of the three skin folds of fat is greater than 60 mm. This outcome is compound by multiple measurements that will be aggregated to arrive at one reported.
Measured: 2018-2023
Cardiovascular capacity
The data will be collected from the clinical registries which have included the National Aeronautics and Space Administration (NASA) method which calculates the Vo2 max and Mets, The formula includes sex, age, BMI, Resting heart rate and physical activity coefficient self-reported. Taking as a reference that a poor physical condition occurs when the estimated maximum oxygen consumption is less than 7 units of the basal metabolic rate. This outcome is compound by multiple measurements that will be aggregated to arrive at one reported.
Measured: 2018-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 Jan 2024
- Primary completion30 Sep 2024
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Universitaria Maria Cano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catalina Lopera Muñetón, Fundacion Universitaria Maria Cano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476015
- Sponsor's protocol ID
- 013008003-2023-
- Status last verified
- Jun 2025
- First submitted
- 30 May 2024
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in Non comunicable diseases. Data or samples shared will be coded. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Physical Exercise on Frailty, Body Composition and Functional Classification of Patients With Chronic Non-communicable Disease
- ClinicalTrials.gov ID
- NCT06476015
- Acronym / sponsor ID
- 013008003-2023-
- Conditions
- COPD, Diabetes, Physical Inactivity, Frailty
- Keywords
- COPD, Diabetes, Excercise, Frailty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fundacion Universitaria Maria CanoUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
According to the Pan American Health Organization (PAHO), chronic, non-communicable diseases (NCDs) are the main cause of death and disability in the world. The term, NCD refers to a group of diseases that are not primarily caused by acute infection and result in long-lasting health consequences, with significant long-term care and treatment needs. These include chronic lung diseases such as COPD and metabolic diseases such as Diabetes. Worldwide, chronic non-communicable diseases are related to physical inactivity as the main risk factor. In this sense, exercise and physical activity have become priority elements of public health, with recommendations that they be carried out with moderate intensity at least 150 minutes a week. In Colombia, exercise as an important strategy for the prevention and management of chronic non-communicable diseases, which is described in the ten-year public health plan. However, in its application in clinical practice, the evidence shows that there are few structured programs at the national or regional level, which monitor the adequate prescription of exercise as a therapeutic strategy for the control of NCDs and improvement. of functionality. Reason for which this research arises, which aims to describe the effectiveness of exercise on the frailty, body composition and functional classification of 300 patients with chronic non-communicable disease.
Detailed description
Non-communicable diseases represent a significant burden on public health worldwide. These are the main cause of premature mortality and disability in the Americas and represent two thirds of all deaths in the region. Comprehensive understanding of the relationship between frailty, body composition, exercise (aerobic and strength) and diseases such as COPD and diabetes, is essential to develop effective preventive and therapeutic strategies. This can not only have an impact on the quality of life of affected individuals, but also in reducing the global burden of these diseases and their comorbidities.
In this sense, diabetes mellitus is a group of metabolic disorders that is characterized by chronic hyperglycemia, due to a defect in insulin secretion, a defect in insulin action, or both. In addition to hyperglycemia, alterations in fat and protein metabolism coexist. Sustained hyperglycemia over time is associated with damage, dysfunction and failure of several organs and systems, especially kidneys, eyes, nerves, heart and blood vessels. On the other hand, physical exercise has proven to be an effective intervention because it improves insulin sensitivity, facilitates glycemic control and reduces cardiovascular risk, also because it helps in managing body weight and improves quality of life in general.
On the other hand, COPD is a chronic respiratory pathological condition characterized by a persistent limitation of expiratory airflow that is partially reversible; It remains one of the main public health problems and is the fourth cause of mortality in the United States. It is known that, within the clinical manifestations or symptoms, there is an impact on the state of health, quality of life and daily activities, which contribute to an increase in levels of anxiety, depression, risk of exacerbations and a worse prognosis of the disease. Performing physical exercise in this population is of vital importance because it improves lung capacity and the efficiency of the cardiovascular system, improves exercise tolerance through strength and resistance training, which makes it easier to perform daily tasks due to to the reduction of symptoms such as dyspnea, reducing exacerbations and hospitalizations, which translates into a better quality of life.
Based on the previous problem, since 2017 the Alma Mater Clinic of Antioquia proposed a comprehensive care program for patients with chronic diseases called "Ser mas" Pluripathologicos, which includes 5,000 patients from the metropolitan area who live near the health center. . In 2021, they published their first study with the objective of evaluating the predictive validity of a classification method based on functional status, the presence of risk factors and the control of comorbidity, on the use of emergency services and hospitalization. , mortality and health care costs in older adults with NCDs. The results describe that functional capacity is an element that could inform and direct intervention actions in this population. Additionally, it suggests that objective measurements of functional status and the presence of frailty in patients with NCDs could be key elements to identify individuals with health needs and guide their interventions in an effective and individualized manner for their well-being. From the above, the current research arises, which aims to evaluate the effectiveness of physical exercise on the frailty, body composition and functional classification of patients with NCDs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women, between 60 and 90 years old, residents in the metropolitan area, with a diagnosis of COPD and/or diabetes who entered the NCD patient care program called "Ser más".
Key inclusion criteria (4 listed)
- Records between 2018 and 2023
- Men and women, between 60 and 90 years old.
- Clinical diagnosis of COPD and/or diabetes.
- Must be patient from program called "Ser más".
Key exclusion criteria (1 listed)
- Records containing incomplete data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic exerciseDuration: 30 minutes. Frequency: Once a week. Type of excercise: Cardiovascular, strengthening and balance. Supervised by a health professional. | Other | – |
Primary outcome
Frailty
Time frame: 2018-2023
The data will be collected from the clinical registries which have included The Groeningen frailty test, walking speed test and single-leg support test. These variables were measured by groningen frailty indicator questionnaire. This scale categorizes patients with significant frailty when they obtain a score ≥ 4. In addition, the walking speed in 5 meters will also be taken into account, which is considered in fragility cut from 0.6 m/sec and the single-leg support time when it is < 10 seconds. This outcome is compound by multiple measurements that will be aggregated to arrive at one reported.
2 secondary outcomes
Body composition
Time frame: 2018-2023
Cardiovascular capacity
Time frame: 2018-2023
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in Non comunicable diseases. Data or samples shared will be coded. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Diabetes, run by Fundacion Universitaria Maria Cano at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact catalina Lopera, Msc (+57 3206728934, catalinaloperamuneton@fumc.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty (time frame: 2018-2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.