Effects and Costs of Respiratory Muscle Training in Institutionalized Elderly People
This study is not yet open for participant recruitment.
Verified January 2013 by University of Valencia
Sponsor:
University of Valencia
Information provided by (Responsible Party):
Maria dels Angels Cebria i Iranzo, PT, PhD, University of Valencia
ClinicalTrials.gov Identifier:
NCT01759992
First received: December 31, 2012
Last updated: January 3, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Muscle Weakness Syndrome; Institutionalization Respiratory Morbidity Cardiovascular Morbidity |
Device: Threshold® Inspiratory Muscle Trainer (sham) Device: Threshold® Inspiratory Muscle Trainer (treatment). |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Determination of the Effects and Costs of Respiratory Muscle Training in Institutionalized Elderly People With Functional Impairment: A Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by University of Valencia:
Primary Outcome Measures:
- Maximum Inspiratory Pressure (MIP) [ Time Frame: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9). ] [ Designated as safety issue: Yes ]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) [ Time Frame: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9). ] [ Designated as safety issue: Yes ]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:
- Maximal Voluntary Ventilation (MVV) [ Time Frame: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9). ] [ Designated as safety issue: Yes ]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). [ Time Frame: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9). ] [ Designated as safety issue: Yes ]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. [ Time Frame: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9). ] [ Designated as safety issue: Yes ]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 Outcome Measures:
- Health-related quality-of-life (CRQ). [ Time Frame: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9). ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 85 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control group
Usual care
|
|
|
Sham Comparator: Sham group
Participants will breathe against a load 10% of their baseline MIP.
|
Device: Threshold® Inspiratory Muscle Trainer (sham)
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 10% of baseline MIP.
Other Name: Respironics® Health Scan Inc. Cedar Grove, NJ, USA
|
|
Experimental: Treatment group
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).
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.
Other Name: Respironics® Health Scan Inc. Cedar Grove, NJ, USA
|
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759992
Contacts
| Contact: Mary Martínez | +34 96 136 62 83 | mmartinez@lasaleta.com |
Locations
| Spain | |
| Grupo Gero Residencias "La Saleta" | Not yet recruiting |
| Valencia, Spain, 46015 | |
| Contact: Mary Martínez +34 96 136 62 83 mmartinez@lasaleta.com | |
| Principal Investigator: M. Àngels Cebrià i Iranzo, PT, PhD | |
Sponsors and Collaborators
University of Valencia
Investigators
| Principal Investigator: | M. Àngels Cebrià i Iranzo, PT, PhD | University of Valencia |
| Study Chair: | M. Ángeles Tortosa Chuliá, PhD | University of Valencia |
| Study Chair: | Celedonia Igual Camacho, PT, PhD | University of Valencia |
| Study Chair: | Laura López Bueno, PT, PhD | University of Valencia |
More Information
Publications:
| Responsible Party: | Maria dels Angels Cebria i Iranzo, PT, PhD, Assistant Professor, University of Valencia |
| ClinicalTrials.gov Identifier: | NCT01759992 History of Changes |
| Other Study ID Numbers: | UV-INV-PRECOMP12-80293, H1335803152705 |
| Study First Received: | December 31, 2012 |
| Last Updated: | January 3, 2013 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by University of Valencia:
|
Frail elderly Muscle weakness Institutionalization Respiratory muscle training |
Additional relevant MeSH terms:
|
Asthenia Muscle Weakness Paresis Signs and Symptoms Muscular Diseases |
Musculoskeletal Diseases Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013