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| ID | Type | Description | Link |
|---|---|---|---|
| DI24-011 | Other Grant/Funding Number | Universidad de La Frontera |
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This study aims to evaluate the effectiveness of an exercise program that includes three exercise modalities (Aerobic, Limb Strength and Respiratory Muscle Strength) versus an exercise program that includes only one modality (Aerobic) in the context of a Pulmonary Rehabilitation program in adults with diffuse interstitial disease in the AraucanÃa Region, in terms of exercise tolerance.
A randomized clinical trial will be conducted, with 2 parallel groups, with masked evaluator. This study will include adults with a diagnosis of Diffuse Interstitial Lung Disease who are referred according to their medical condition and who agree to participate through an informed consent form. Participants will be recruited in the community and will be referred to the Physical Function and Rehabilitation Laboratory of the Faculty of Medicine of the Universidad de La Frontera, where they will be evaluated and subsequently randomly assigned to each group. The evaluation consists of a series of tests and instruments to collect information regarding dyspnea, exercise tolerance, muscle strength and lung function, among others. The intervention corresponds to a Pulmonary Rehabilitation program, where both groups will receive education in psychological and nutritional aspects, self-care and physical activity. The difference between groups is that the control group will receive an intervention with an aerobic exercise modality and the experimental group will receive three exercise modalities together (aerobic, strengthening of extremities and strengthening of respiratory muscles).The program will last 10 weeks, with sessions twice a week, and at the end of the program the initial parameters will be re-evaluated.
Data analysis will be performed using descriptive statistical elements, such as distribution tables and graphs. The inferential analysis will be performed using Chi2 for the association between the intervention and the main outcome variable, in addition to the calculation of RR to assess the magnitude of the association; the secondary outcome variables will be calculated for the primary outcome variable association; secondary outcome variables will be analyzed using Student's t-test.
General Objective: To evaluate the effectiveness of an exercise program that includes three exercise modalities (Aerobic, Limb Strength and Respiratory Muscle Strength) versus an exercise program that includes only one modality (Aerobic) in the context of a Pulmonary Rehabilitation program in adults carriers of diffuse interstitial disease in the AraucanÃa Region, in terms of exercise tolerance.
Specific Objectives:
Design It corresponds to a randomized clinical trial, 2 parallel groups, with masked evaluator. This design is the one that provides the best certainty of evidence to attribute causality, therefore, to evaluate the effectiveness of an intervention.
Sample The study population will be adults with a medical diagnosis of diffuse lung disease, clinically stable, who are under medical treatment (In the original text it said: "in the Polyclinic of Respiratory Diseases", however, due to the sample size obtained, as a team we decided to make a free invitation to those who wish to participate and are under medical treatment in the public or private sector).
The sample will be constituted by participants who meet the following eligibility criteria:
Inclusion Criteria.
Exclusion Criteria
In the sample size calculation, a number of 26 subjects was obtained, considering a significance level of 5%, a power of 80%, an estimated difference between the groups under study of 40 (±35) meters walked in the main response variable, evaluated with the 6-minute Walk Test (De las Heras JC, Hilberg O, Lokke A, Bendstrup E. Tele-rehabilitation program in Idiopathic Pulmonary Fibrosis. European Respiratory Journal. 2019). Considering a 10% loss, the final sample size will be 29 individuals.
Evaluation: A set of physical assessments and questionnaires that evaluate the following.
functional parameters:
Training: is the intervention itself and consists of aerobic physical exercise or a combination of 3 modalities:
All interventions will take place at the Faculty of Medicine of the Universidad de La Frontera, located at Claro Solar 115, and the Laboratory of Physical Fitness and Rehabilitation of the Universidad de La Frontera, located at 18 de Septiembre 525, 6th floor.
This research has been approved by the Scientific Ethics Committee of Universidad de La Frontera, Act Number 119_2024.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | Control (Aerobic excercise) |
|
| Intervention | Experimental | Intervention (Muscle strength limbs, inspiratory muscle strength, aerobic exercise) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic excersise | Procedure | 20 aerobic exercise sessions, with a duration of 45 to 60 minutes, for 10 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exercise tolerance | It is the body's ability to withstand physical activity. It is measured by the duration and intensity of exercise that a person can perform without excessive fatigue, pain or shortness of breath. | Baseline and then at the end of the 10-week training period |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived effort | Corresponds to the subjective feeling of how demanding a physical activity is. It reflects the intensity with which one feels one's body is working, from "very light" to "maximum effort". It is a useful tool for regulating exercise intensity according to the patient's perception. For the purposes of this study, the perception of exertion will be assessed using the Modified Borg Scale from 0 to 10 points, where 0 corresponds to "No dyspnea" and 10 "Very, very severe". |
| Measure | Description | Time Frame |
|---|---|---|
| Age | Number of years of age at study entry | Baseline |
| Gender | Biological sex | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de La Frontera | Temuco | CautÃn | 4780000 | Chile |
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| Label | URL |
|---|---|
| Web page of School of Medicine Universida de La Frontera | View source |
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Study protocol
Five years since publication in Clinical Trials.
All people, just contact for e-mail.
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| Muscle strength limbs, inspiratory muscle strength | Procedure | 20 sessions of exercise Muscle strength limbs, inspiratory muscle strength, with a duration of 60 minutes, for 10 weeks |
|
| Baseline and then at the end of the 10-week training period |
| Dyspnea | Subjective sensation of shortness of breath or difficulty breathing. It may be mild or severe, acute or chronic. It is a frequent symptom of various pulmonary or cardiac conditions, but may also be due to anxiety or intense exercise. To assess Dyspnea, we use the Modified Medical Research Council (mMRC) scale, where 0 is "No shortness of breath except during strenuous exercise" and 4 is "Choking sensation during day-to-day exertion such as getting dressed or going out of the house and need for rest". | Baseline and then at the end of the 10-week training period |
| Inspiratory muscle strength | Inspiratory muscle strength is the ability of the respiratory muscles to expand the lungs during inspiration. It is measured by the maximum pressure they can generate when breathing in against resistance. A good level of inspiratory strength is crucial for efficient breathing and good lung health. It will be assessed by an isokinetic valve (PowerBreatheK5), using the best value obtained from 5 attempts, 'for this a continuous scale in cmH2O is used. | Baseline and then at the end of the 10-week training period |
| Muscle strenght of limbs | Ability of arm muscles to generate tension and overcome resistance. It is measured by the amount of force they can produce when pushing, pulling or lifting objects. This strength is essential for everyday activities such as walking, lifting, or playing sports. To assess the muscle function of lower limbs, we mesured through the Sit to Stand Test in 1 minute (STST-1m), with the values standardized for Chilean adults by Otto et al. | Baseline and then at the end of the 10-week training period. |
| Muscle strenght of arms | Ability of arm muscles to generate tension and overcome resistance. It is measured by the amount of force they can produce when pushing, pulling or lifting objects. This strength is essential for everyday activities such as walking, lifting, or playing sports. To assess the muscle function of arms, it will be evaluated by means of prehensile dynamometry, taking as reference values those established by Romero-Dapueto, et al. for Chilean adults. | Baseline and then at the end of the 10-week training period |
| Pulmonary Function | Refers to the ability of the lungs to exchange oxygen and carbon dioxide between air and blood. It involves processes such as ventilation (air inflow and outflow), diffusion (passage of gases) and perfusion (pulmonary blood flow). For this study we will use the Forced Vital Capacity (FVC), the Forced Expiratory Volume in the first second (FEV1) measured in liters, and the ratio between both values (FEV1/FVC) established as a percentage. In addition, the statistical value obtained, according to the reference values of the Global Lung Function Initiative (GLI). | Baseline and then at the end of the 10-week training period |
| Treatment Adherence | Extent to which a patient follows his or her physician's recommendations. It involves attending medical appointments and following lifestyle changes. Good adherence is crucial for successful treatment and improved health. Adherence will be measured in relation to the number of sessions the subject completes, i.e. completing the 20 training sessions counts as adherence and a lower number means non-adherence to treatment. | Baseline and then at the end of the 10-week training period |
| Adverse Effects | Unwanted reactions that may occur as a result of a treatment, such as the performance of a procedure. They can range from mild to severe. The American College of Sports Medicine has established a series of adverse effects of training, which we have listed and will be checked at each session to assess whether there were adverse effects of training. Among the problems that could occur are the following:
| Baseline, in each of the training sessions and in the reevaluation. |
| Functionality | The ability of a system, object or person to perform the functions for which it was designed or adapted. It implies efficiency, utility and fitness for a specific purpose. In people, it refers to the ability to perform activities of daily living and participate in society. this parameter will be evaluated through the Activities of Daily Living Questionnaire (ADLQ-T). | Baseline and then at the end of the 10-week training period |
| Cognition | Encompasses the mental processes that make it possible to acquire, process and use information. It includes functions such as attention, memory, language, perception, reasoning and problem solving. It is the basis of knowledge, learning and interaction with the environment. This parameter will be evaluated through the Montreal Cognitive Assessment (MoCA). | Baseline and then at the end of the 10-week training period |
| Previous hospitalizations | Number of previous hospitalizations, since diagnosis | Baseline |
| Years since diagnosis | Years since medical diagnosis | Baseline |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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