NCT06476015

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2024

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 26, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

9 months

First QC Date

May 30, 2024

Last Update Submit

June 5, 2025

Conditions

Keywords

COPDDiabetesExcerciseFrailty

Outcome Measures

Primary Outcomes (1)

  • 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.

    2018-2023

Secondary Outcomes (2)

  • Body composition

    2018-2023

  • Cardiovascular capacity

    2018-2023

Other Outcomes (1)

  • Functional classification

    2018-2023

Interventions

Duration: 30 minutes. Frequency: Once a week. Type of excercise: Cardiovascular, strengthening and balance. Supervised by a health professional.

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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".

You may qualify if:

  • 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".

You may not qualify if:

  • Records containing incomplete data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundación Universitaria María cano

Medellín, Antioquia, 05000, Colombia

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDiabetes MellitusSedentary BehaviorFrailty

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 30, 2024

First Posted

June 26, 2024

Study Start

January 1, 2024

Primary Completion

September 30, 2024

Study Completion

August 30, 2025

Last Updated

June 10, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
ICF, CSR
Time Frame
Data requests can be submitted starting 12 months after article publication and the data will made accessible for up to 18 months. Extensions will be considered on a case-by-case basis
Access Criteria
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact catalinaloperamuneton@fumc.edu.co

Locations