Physical Exercise Program for Adults With Diffuse Interstitial Lung Disease in a Pulmonary Rehabilitation Context
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Exercise tolerance
研究概览
简要总结
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 Araucanía 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.
详细描述
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 Araucanía Region, in terms of exercise tolerance.
Specific Objectives:
- To evaluate the effectiveness of an exercise program that includes three modalities (Aerobic, Limb Strength and Respiratory Muscle Strength) versus an exercise program of only one modality (Aerobic) in the context of a Pulmonary Rehabilitation program in adults carriers of diffuse interstitial disease in the Araucanía Region, in terms of exercise tolerance.
- To evaluate the effectiveness of an exercise program with three modalities (Aerobic, Limb Strength and Respiratory Muscle Strength) versus a one-modality exercise program (Aerobic) within a Pulmonary Rehabilitation program in adults with diffuse interstitial disease in the Araucanía Region, in terms of dyspnea control.
- To evaluate the effectiveness of an exercise program with three modalities (Aerobic, Limb Strength and Respiratory Muscle Strength) versus an exercise program with one modality (Aerobic) within a Pulmonary Rehabilitation program in adults with diffuse interstitial disease in the Araucanía Region, in Health-Related Quality of Life.
- To evaluate the effectiveness of an exercise program with three modalities (Aerobic, Limb Strength and Respiratory Muscle Strength) versus an exercise program with one modality (Aerobic) within a Pulmonary Rehabilitation program in adults with diffuse interstitial disease of the Araucanía Region, in terms of upper limb strength.
- To evaluate the effectiveness of an exercise program with three modalities (Aerobic, Limb Strength and Respiratory Muscle Strength) versus an exercise program with one modality (Aerobic) within a Pulmonary Rehabilitation program in adults with diffuse interstitial disease in the Araucanía Region, in terms of lower limb strength.
- To evaluate the effectiveness of an exercise program with three modalities (Aerobic, Limb Strength and Respiratory Muscle Strength) versus an exercise program with one modality (Aerobic) within a Pulmonary Rehabilitation program in adults with diffuse interstitial disease in the Araucanía Region, in terms of inspiratory muscle strength.
- To evaluate the effectiveness of an exercise program with three modalities (Aerobic, Limb Strength and Respiratory Muscle Strength) versus an exercise program with one modality (Aerobic) within a Pulmonary Rehabilitation program in adults with diffuse interstitial disease in the Araucanía Region, in pulmonary function.
- To evaluate the adherence to treatment of an exercise program with three modalities (Aerobic, Limb Strength and Respiratory Muscle Strength) and the exercise program of one modality (Aerobic) in the context of a Pulmonary Rehabilitation program in adults with diffuse interstitial disease in the Araucanía Region.
- To evaluate the incidence of adverse effects that lead to stopping the exercise session according to the exercise program: with three modalities (Aerobic, Limb Strength and Respiratory Muscle Strength) versus a one-modality exercise program (Aerobic) in the context of a Pulmonary Rehabilitation program in adults with diffuse interstitial disease in the Araucanía Region.
- To describe the functionality in users who enter the Pulmonary Rehabilitation program for adults with diffuse interstitial disease in the Araucanía Region.
- To describe the cognitive function in users who enter the Pulmonary Rehabilitation program for adults with diffuse interstitial disease in the Araucanía Region.
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years of age or older.
- •Medical Diagnosis of Diffuse Interstitial Pulmonary Disease.
- •Medical Referral to pulmonary rehabilitation according to stability criteria.
- •Sign the Informed Consent form.
排除标准
- •Neuromotor impairment that prevents independent transfer.
- •Cognitive deficit that prevents you from understanding simple instructions.
- •General exercise contraindications according to the American College of Sports Medicine.
研究组 & 干预措施
Intervention
Intervention (Muscle strength limbs, inspiratory muscle strength, aerobic exercise)
干预措施: Aerobic excersise (Procedure)
Control
Control (Aerobic excercise)
干预措施: Aerobic excersise (Procedure)
Intervention
Intervention (Muscle strength limbs, inspiratory muscle strength, aerobic exercise)
干预措施: Muscle strength limbs, inspiratory muscle strength (Procedure)
结局指标
主要结局
Exercise tolerance
时间窗: Baseline and then at the end of the 10-week training period
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.
次要结局
- Perceived effort(Baseline and then at the end of the 10-week training period)
- Dyspnea(Baseline and then at the end of the 10-week training period)
- Inspiratory muscle strength(Baseline and then at the end of the 10-week training period)
- Muscle strenght of limbs(Baseline and then at the end of the 10-week training period.)
- Muscle strenght of arms(Baseline and then at the end of the 10-week training period)
- Pulmonary Function(Baseline and then at the end of the 10-week training period)
- Treatment Adherence(Baseline and then at the end of the 10-week training period)
- Cognition(Baseline and then at the end of the 10-week training period)
- Adverse Effects(Baseline, in each of the training sessions and in the reevaluation.)
- Functionality(Baseline and then at the end of the 10-week training period)
研究者
Sayen Huaiquilaf-Jorquera
Physical Therapist; Specialist in Ventilatory Terapy; Master in Innovation of Universitary Pedagogy in Education Science; Academic Department Science of Rehabilitation, University of La Frontera
Universidad de La Frontera