Cardiovascular Morbidity, Muscle Weakness, Respiratory Morbidity, Syndrome; Institutionalization
Conditions
Keywords
Frail elderly, Muscle weakness, Institutionalization, Respiratory muscle training
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.
Interventions
DEVICEThreshold® Inspiratory Muscle Trainer (treatment).
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.
Sponsors
University of Valencia
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality-of-life (CRQ). | The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9). | Chronic Respiratory Questionnaire (CRQ) is an designed instrument to evaluate the impact of interventions, including respiratory rehabilitation. The CRQ includes 20 items divided into four domains: dyspnoea (five items); fatigue (four items); emotional function (seven items); and mastery, a domain which explores how patients cope with their chronic illness (four items). Reference: Güell R, Casan P, Sangenís M, et al. Quality of life in patients with chronic respiratory disease: the Spanish version of the Chronic Respiratory Questionnaire (CRQ). Eur Respir J. 1998; 11(1):55-60. |
Countries
Spain
Outcome results
None listed