Effects and Costs of Respiratory Muscle Training in Institutionalized Elderly People

Study Overview
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Brief Summary
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The global loss of muscle mass and strength associated with aging is a cause of functional impairment and disability, particularly in the older elderly (>80 years). Respiratory function can be severely compromised if there is a decrease of respiratory (RM) strength complicated by the presence of comorbidities and physical immobility. In this context, the need for supportive services involves the need for long-term care and consequently the institutionalization. Previous studies have shown that the increase of RM strength has positive healthy effects, such as the increase in functional capacity, the decrease in RM fatigue, the decrease of dyspnoea and the improvement of quality of life, both in healthy people and patients. Therefore, specific RM training may be regarded as a beneficial alternative to improve RM function, and thus prevent physical and clinical deterioration in this frail population. Study hypothesis: The inspiratory muscle training (IMT) would improve respiratory muscle strength and endurance, exercise capacity and quality of life in an elderly population, who are unable to engage in general exercise conditioning.

Official Title
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Determination of the Effects and Costs of Respiratory Muscle Training in Institutionalized Elderly People With Functional Impairment: A Randomized Controlled Trial

Conditions
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Muscle Weakness, Syndrome; Institutionalization, Respiratory Morbidity, Cardiovascular Morbidity

Intervention / Treatment
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* Device: Threshold® Inspiratory Muscle Trainer (treatment).


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: People aged > 65 years Barthel Index < 75 score Mini-mental state examination ≥ 20 score Inspiratory muscle weakness (MIP ≤ 30% predicted value) Exclusion Criteria: Ability to independently walk more than 14 m Significant chronic cardiorespiratory diagnoses Acute cardiorespiratory episode during the 2 previous months Neurological, muscular, or neuromuscular problems interfering with the capacity to engage in the tests and training protocol Active smokers or former smokers (< 5 years) A terminal disease

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Usual care | |
| Experimental: Treatment group<br>Participants will breathe against a load ≥ 50% of their baseline MIP, after which loads will increase according to the participant's tolerance across the remaining training period, using a Borg scale rating of 4 to 6 on perceived exertion as an indicator of adequate training intensity. | Device: Threshold® Inspiratory Muscle Trainer (treatment).<br>* Interval-based program consisting of seven cycles of 2-minutes work and 1-minute rest. The sessions will take place 3 times per week over a eight-week period for a total of 24 sessions. All participants were familiarized with the breathing exercises over a two-week familiarization period at the beginning of the protocol. The load will be adjusted at ≥ 50% of baseline MIP.<br>* Other names: Respironics® Health Scan Inc. Cedar Grove, NJ, USA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Inspiratory Pressure (MIP) | MIP is probably the most frequently reported noninvasive estimates of inspiratory muscle strength. Ever since Black and Hyatt (1969) reported this technique it has been widely used in patients, healthy control subjects across all ages, and athletes. Pressure is recorded at the mouth during a quasi-static short (few seconds) maximal inspiration. The manoeuvre is generally performed at Residual Volume (RV). Reference: Am J Respir Crit Care Med. 2002;166:531-535. | The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9). | 
| Maximum Expiratory Pressure (MEP) | MEP is probably the most frequently reported noninvasive estimates of expiratory muscle strength. Ever since Black and Hyatt (1969) reported this technique it has been widely used in patients, healthy control subjects across all ages, and athletes. Pressure is recorded at the mouth during a quasi-static short (few seconds) maximal expiration. The manoeuvre is generally performed at Total Lung Capacity (TLC). Reference: Am J Respir Crit Care Med. 2002;166:531-535. | The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal Voluntary Ventilation (MVV) | This ventilatory test is a non-invasive technique and is a measure of both inspiratory and expiratory muscle endurance. The MVV is the largest volume that can be breathed in and out of the lungs during a 12 -15 second interval with maximal voluntary effort. Reference: Am J Respir Crit Care Med. 2002;166:562-564. | The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9). | 
| Time performed to walk 10 m distance (10mWT). | The 10-Meter Walk Test (10mWT) is a measure of gait speed. The walking course consist of 14 m in a hallway: a 2 m warm-up, 10 m use for the speed measurement, and 2 m for slowing down to stop. Participants can use the assistive device (eg, cane, walker) or orthotic device (eg, ankle-foot orthosis) that they use most often (if any) at each time point. Reference: Tilson JK, Sullivan KJ, Cen SY, et al. Meaningful gait speed improvement during the first 60 days poststroke: minimal clinically important difference. Phys Ther. 2010;90(2):196-208. | The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9). | 
| Maximal heart rate achieved at the end of the incremental arm ergometry test. | The incremental arm ergometry test begins with a 3 minutes warm-up (50-70 rpm) and continues with an incremental power of 10 W each 2 minutes. The test concludes when the heart rate achieves 80% of maximum theoretical heart rate (220-age) and/or inability to maintain 50 rpm. Reference: Franklin BA. Exercise testing, training, and arm ergometry. Sports Med. 1985;2(2):100-19 | The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frail elderly, Muscle weakness, Institutionalization, Respiratory muscle training