Effects and Costs of Respiratory Muscle Training in Institutionalized Elderly People
- Conditions
- Respiratory MorbidityCardiovascular MorbidityMuscle WeaknessSyndrome; Institutionalization
- Interventions
- Device: Threshold® Inspiratory Muscle Trainer (treatment).
- Registration Number
- NCT01759992
- Lead Sponsor
- University of Valencia
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- People aged > 65 years
- Barthel Index < 75 score
- Mini-mental state examination ≥ 20 score
- Inspiratory muscle weakness (MIP ≤ 30% predicted value)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Treatment group Threshold® Inspiratory Muscle Trainer (treatment). 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.
- Primary Outcome Measures
Name Time Method Maximum Inspiratory Pressure (MIP) The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9). 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.
Maximum Expiratory Pressure (MEP) The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9). 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.
- Secondary Outcome Measures
Name Time Method Maximal Voluntary Ventilation (MVV) The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9). 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.
Time performed to walk 10 m distance (10mWT). The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9). 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.
Maximal heart rate achieved at the end of the incremental arm ergometry test. The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9). 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
Trial Locations
- Locations (1)
Grupo Gero Residencias "La Saleta"
🇪🇸Valencia, Spain