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:
* Can eligible participants be successfully recruited and enrolled? * Can participants complete the 14-day follow-up and daily self-report diary? * Can the AIRE intervention be delivered as planned? * Can participants assigned to AIRE follow the respiratory self-care recommendations and breathing exercises?
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:
* Receive telephone follow-up during the 14 days after enrollment * Record their symptoms, daily activities, and use of health services in a self-report diary * Report any new medical visits, hospital admissions, or respiratory complications
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.
Adults of any sex aged 60 to 80 years.
Clinical diagnosis of an ambulatory influenza-like illness, defined as acute-onset cough with fever or a feeling of fever, plus at least one of the following symptoms: muscle aches, sore throat, or headache. Laboratory confirmation of the causative pathogen is not required.
Five days or less since the onset of the first symptom.
Presence of at least one of the following chronic conditions or risk factors: hypertension, dyslipidemia, diabetes mellitus, obesity defined as a body mass index of 30 kg/m² or higher, chronic kidney disease, or current smoking.
Need for antibiotic treatment at the initial visit because of an evident or suspected bacterial infection.
Cognitive impairment that prevents understanding of the study or intervention.
Cancer under active treatment.
Physical limitations that prevent performance of the breathing exercises.
Parallel
AIRE Comprehensive Respiratory Self-Care Intervention
BehavioralAIRE 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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