An interventional study of AIRE Comprehensive Respiratory Self-Care Intervention in Acute Respiratory Tract Infections, sponsored by University of Chile. Recruiting at 1 site in Chile. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by University of Chile · Not applicable, Interventional, and Prevention
Acute respiratory infections are common reasons for seeking primary care. Most people recover at home, but some older adults may develop respiratory complications or worsening of long-term health conditions. Clear guidance about safe activity, breathing exercises, symptom monitoring, and when to seek further care may support recovery.
The goal of this pilot clinical trial is to assess whether the AIRE respiratory self-care intervention and the planned study procedures can be carried out successfully in adults aged 60 to 80 years who receive care for an acute respiratory infection in a primary care center. The pilot will inform the procedures for a larger randomized clinical trial designed to evaluate whether AIRE can prevent complications.
The main questions this pilot study aims to answer are:
Researchers will also explore whether participants who receive AIRE experience fewer respiratory complications within 14 days than participants who receive usual care. The pilot study is not designed to provide a definitive test of the clinical effectiveness of AIRE.
Participants will be randomly assigned to one of two groups. Participants in the AIRE group will receive usual care plus a respiratory self-care session. The session will include guidance about hydration, safe daily activity, avoidance of prolonged bed rest, warning signs, and simple breathing exercises. Participants will also receive supporting educational material. Participants in the control group will receive usual care without the AIRE intervention.
Participants in both groups will:
The respiratory complications assessed will include sinusitis, bronchitis, pneumonia, and worsening of a long-term health condition. The findings will help researchers identify changes needed before conducting the larger clinical trial.
University of Chile is the lead sponsor of 194 studies on the registry; 38 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this arm will receive the AIRE intervention in addition to usual care for acute respiratory infections. The intervention includes respiratory self-care education, guidance to support safe recovery at home, and breathing exercise instruction. Participants will complete the same follow-up and outcome assessments as the control group.
Behavioral: AIRE Comprehensive Respiratory Self-Care Intervention
Participants assigned to this arm will receive usual care for acute respiratory infections according to standard practice at the primary care center, without the AIRE self-care education or breathing exercise instruction. They will undergo the same study follow-up and outcome assessments as participants in the experimental group.
AIRE is a multicomponent respiratory self-care intervention delivered individually by a trained respiratory physical therapist. Participants receive a structured education session lasting approximately 10 minutes. The session covers hydration, warning signs, safe daily activity, and recommendations to avoid prolonged bed rest during recovery. Participants are taught breathing control followed by slow exhalation through pursed lips. Each breathing exercise session lasts approximately 5 to 10 minutes and is performed twice daily for 5 to 10 consecutive days, according to symptoms and tolerance. Participants are advised to stop the exercises if they experience dizziness, marked shortness of breath, chest pain, or worsening symptoms. Printed or audiovisual materials reinforce the recommendations and exercise instructions.
Participant Recruitment Rate
The proportion of eligible individuals who provide informed consent and are enrolled in the study. The recruitment rate will be calculated as the number of participants enrolled divided by the total number of eligible individuals invited to participate, multiplied by 100. The number of individuals screened, eligible, invited, and enrolled will be recorded. Reasons for exclusion, refusal, or non-enrollment will also be documented and summarized by category.
Time frame: Baseline
Completion of 14-Day Follow-Up
The proportion of enrolled participants who complete the final study assessment on day 14. A participant will be considered to have completed follow-up if information on symptoms, healthcare use, and possible respiratory complications is available through the day 14 telephone assessment or clinical record review. The measure will be reported as the number of participants who complete follow-up divided by the total number enrolled, multiplied by 100.
Time frame: From enrollment to 14 days after enrollment
Completion of the Daily Self-Report Diary
The proportion of expected daily self-report diary entries completed by participants during the 14-day follow-up period. The diary records symptoms, daily activity, ability to perform usual activities, healthcare use, and, for participants assigned to AIRE, performance of breathing exercises. Completion will be calculated as the number of diary entries submitted divided by the total number of expected entries, multiplied by 100.
Time frame: Daily, from enrollment to 14 days after enrollment
Adherence to AIRE Breathing Exercises
The proportion of prescribed breathing exercise sessions completed by participants assigned to the AIRE intervention. Participants are instructed to perform two breathing exercise sessions per day for 5 to 10 days, according to symptoms and tolerance. Adherence will be calculated as the number of sessions reported as completed divided by the total number of sessions prescribed to each participant, multiplied by 100. Participants completing at least 80% of their prescribed sessions will also be classified as adherent. Daily adherence will be obtained from the self-report diary.
Time frame: Daily, from enrollment through day 10 after enrollment
Incidence of Respiratory Complications Within 14 Days
The proportion of participants who develop at least one predefined respiratory or clinical complication during follow-up. The composite outcome includes sinusitis, bronchitis, pneumonia, or worsening of a pre-existing chronic health condition. Possible complications will be identified through telephone follow-up, self-report diaries, healthcare visits, and clinical record review using predefined diagnostic criteria.
Time frame: From enrollment to 14 days after enrollment
Successful Completion of Scheduled Telephone Contacts
The proportion of the six scheduled telephone follow-up contacts completed for each participant. Telephone contacts are scheduled on days 3, 5, 7, 10, 12, and 14 after enrollment. Completion will be calculated as the number of completed calls divided by six, multiplied by 100. The duration of each call, unsuccessful contact attempts, and reasons for missed calls will also be documented.
Time frame: From enrollment to 14 days after enrollment
Successful Delivery of the AIRE Intervention
The proportion of participants assigned to the AIRE intervention who receive all planned components of the initial intervention session. Complete delivery will require respiratory self-care education, guidance on hydration and warning signs, recommendations for safe daily activity and avoidance of prolonged bed rest, breathing exercise instruction, and provision of supporting educational material. Completion will be documented using the structured AIRE intervention checklist and calculated as the number of participants who receive all planned components divided by the total number assigned to the AIRE arm, multiplied by 100.
Time frame: Day 1
Duration of the Initial AIRE Intervention Session
The time required for the respiratory physical therapist to deliver the initial AIRE intervention session, measured in minutes from the beginning to the end of the structured education and breathing exercise instruction. Results will be reported using the mean, standard deviation, median, and range.
Time frame: Day 1
Frequency of Operational Problems During Study Implementation
The number and type of operational problems recorded during participant screening, enrollment, randomization, intervention delivery, telephone follow-up, diary completion, and data entry. Problems may include delays, missing information, failed contact attempts, workflow disruptions, errors in study procedures, technical problems with the data collection system, difficulties using WhatsApp, problems receiving educational materials or submitting diary information, the need for assistance from a caregiver, and difficulties understanding the informed consent process, study procedures, or random group assignment. Events will be documented in the study technical log and summarized by category and frequency.
Time frame: From participant screening to 14 days after enrollment
Acceptability of the AIRE Intervention
The number and proportion of participants assigned to the AIRE intervention who report difficulty, discomfort, refusal, or inability to follow one or more intervention components. Acceptability will be assessed for respiratory self-care education, recommendations to avoid prolonged bed rest, breathing exercises, supporting educational materials, telephone follow-up, and use of WhatsApp. Reasons for difficulty or non-acceptance will be documented in the study technical log and summarized by intervention component and category.
Time frame: From the initial intervention session to 14 days after enrollment
Adverse Events Related to the AIRE Intervention
The number and proportion of participants assigned to the AIRE intervention who experience any adverse event during or after performing the breathing exercises or following the activity recommendations. Events may include dizziness, marked shortness of breath, chest pain, worsening symptoms, or any other unexpected medical problem considered possibly related to the intervention. Events will be recorded during telephone follow-up and in the self-report diary and summarized by type, severity, and relationship to the intervention.
Time frame: From the initial intervention session to 14 days after enrollment
Plan to share: Undecided — The study team intends to consider sharing de-identified individual participant data after completion of the pilot study and the subsequent full-scale randomized controlled trial. However, the final data-sharing plan has not yet been established. The decision will depend on participant consent, ethics committee requirements, institutional policies of the Universidad de Chile, and the availability of appropriate procedures to ensure anonymization, confidentiality, and responsible data access.
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Oct 2026, 1 month after the start.
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