This study aims to evaluate the effects of an 8-week inspiratory muscle training program on maximal inspiratory pressure and functional capacity in frail older adults aged 80 years and above. Frailty is associated with reduced physical capacity, declines in functional performance, impaired respiratory performance, and a higher risk of disability. Inspiratory muscle training is a simple, low-cost intervention that may improve breathing function, inspiratory muscle strength, and overall health in very old adults, but evidence in this age group remains limited.
Participants will be randomly assigned to one of two groups: a high-load inspiratory muscle training group or a low-load sham training group. Both groups will use a threshold device and perform 30 breaths once per day, five days per week, for eight weeks. The experimental group will train with progressively increasing resistance (50% to 80% of maximal inspiratory pressure), while the sham group will use a minimal and non-progressive load (15% of maximal inspiratory pressure). All sessions will be supervised and monitored for safety.
The main goal of the study is to determine whether inspiratory muscle training improves maximal inspiratory pressure (MIP), an established measure of global inspiratory muscle strength. Secondary outcomes include measures of functional capacity, reflecting the ability to perform physical tasks relevant to daily living in very old adults. These outcomes will allow the evaluation of the clinical relevance of improvements in inspiratory muscle strength in this population.
Assessments will be performed before the intervention, immediately after the 8-week program, and again at one and three months after the end of the intervention to examine both immediate and short-term effects. This study may contribute valuable evidence regarding the safety, feasibility, and clinical benefits of inspiratory muscle training in frail very old adults, particularly its impact on inspiratory muscle strength and functional capacity, supporting its potential implementation in rehabilitation and geriatric care.
Adults aged 80 years or older.
Clinical diagnosis of frailty, defined by a Short Physical Performance Battery (SPPB) score < 9.
Ability to stand and walk with or without assistive devices.
Ability to understand and follow instructions for inspiratory muscle training.
Acute or unstable cardiovascular, respiratory, or metabolic conditions.
Severe cognitive impairment that prevents understanding the procedures.
Diagnosis of neuromuscular diseases affecting respiratory muscles (e.g., ALS, myopathies).
Severe or uncontrolled hypertension (≥180/110 mmHg).
Parallel
Inspiratory Muscle Training
DeviceParticipants perform 30 breaths once daily, 5 days per week for 8 weeks using a threshold inspiratory muscle training device. The load begins at 50% of maximal inspiratory pressure (MIP) and increases by 5 cmH#O weekly up to 80% of MIP. Sessions are supervised and oxygen saturation and heart rate are monitored.
Sham Inspiratory Muscle Training
DeviceParticipants use the same device and schedule as the experimental group (30 breaths once daily, 5 days per week for 8 weeks) but with a constant load of 15% of maximal inspiratory pressure (MIP), with no weekly progression. This mimics the procedure while providing minimal physiological stimulus. Supervision and monitoring are identical to the experimental arm.
Maximal Inspiratory Pressure (MIP)
Maximal Inspiratory Pressure (MIP) will be measured using a calibrated handheld manometer following standardized respiratory assessment guidelines. Participants will be instructed to perform a maximal inspiratory effort from residual volume through the mouthpiece with their nose occluded. At least three maneuvers will be recorded, ensuring less than 10% variability between attempts. The highest reproducible value (cmH₂O) will be used for analysis. This measure reflects global inspiratory muscle strength and is widely validated in older and frail populations.
Six-Minute Walk Test (6MWT)
Functional exercise capacity will be assessed using the Six-Minute Walk Test (6MWT). Participants will be instructed to walk at their fastest possible pace for six minutes along a 30-meter corridor, covering the greatest distance possible. The total distance walked (in meters) will be recorded. Participants will be continuously accompanied by the therapist and may use assistive devices and/or supplemental oxygen if required.
Timed Up and Go Test (TUG)
Functional mobility and fall risk will be evaluated using the Timed Up and Go (TUG) test. Participants will start seated in a chair with armrests. On command, they will stand up, walk 3 meters, turn around, return to the chair, and sit down. The total time to complete the task will be recorded in seconds. Interpretation criteria: \< 20 seconds: normal performance ≥ 20 seconds: increased risk of falls
Five Times Sit-to-Stand Test (5STS)
Lower limb functional strength will be assessed using the Five Times Sit-to-Stand Test (5STS). Participants will sit on a 43-45 cm high chair without armrests, with arms crossed over the chest, and will be instructed to stand up and sit down five times as quickly as possible. The total time to complete the test will be recorded in seconds. The minimal detectable change ranges from 3.6 to 4.2 seconds, and the minimal clinically important difference is 2.3 seconds. Age-related normative values will be considered for interpretation.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
