Effects and Costs of Respiratory Muscle Training in Institutionalized Elderly People

This study has been completed.
Sponsor:
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: March 18, 2014
Last verified: March 2014
  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 (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

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.


Enrollment: 45
Study Start Date: January 2013
Study Completion Date: December 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Usual care
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01759992

Locations
Spain
Grupo Gero Residencias "La Saleta"
Valencia, Spain, 46015
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: March 18, 2014
Health Authority: Spain: Ethics Committee

Keywords provided by University of Valencia:
Frail elderly
Muscle weakness
Institutionalization
Respiratory muscle training

Additional relevant MeSH terms:
Muscle Weakness
Paresis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014