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Respiratory Muscle Training in Institutionalized Elderly Population

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:
NCT01624272
First received: June 13, 2012
Last updated: June 22, 2012
Last verified: June 2012
History of Changes
  Purpose

The global loss of muscle mass and strength associated with aging is a cause of functional impairment and disability, particularly in the frail elderly. Respiratory function can be severely compromised if there is a decrease of respiratory (RM) strength complicated by the presence of comorbidities and physical immobility.

Previous studies have shown that the specific RM training is an effective method to increase RM strength, both in healthy people and patients. In this case, specific RM training may be regarded as a beneficial alternative to improve RM function, and thus prevent physical and clinical deterioration in this population.

The hypothesis is that specific RM training would improve RM strength and endurance in the experimental groups vs. control who do not participate in RM training.

Institutionalized elderly people with an inability to walk were randomly allocated to a control group, a Threshold group or a Pranayama group. Both experimental groups performed a supervised RM training, five days a week for six consecutive weeks. The maximum inspiratory and expiratory pressures (MIP and MEP) and the maximum voluntary ventilation (MVV) were assessed at four time points in each of three groups.


Condition Intervention
Muscle Weakness
Syndrome; Institutionalization
Other Diagnoses, Comorbidities, and Complications
 Device: Threshold® Inspiratory Muscle Trainer (Respironics® Health Scan Inc. Cedar Grove, NJ, USA).
Other: Yoga Pranayama breathing exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effectiveness of Pranayama Breathing Exercises vs. Threshold Inspiratory Muscle Trainer to Improve Respiratory Muscle Function in an Institutionalized Frail Elderly Population

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Valencia:

Primary Outcome Measures:
  • Change from baseline in Maximum Inspiratory Pressure (MIP) at 7 weeks [ Time Frame: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 7). ] [ 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.

  • Change from baseline in Maximum Expiratory Pressure (MEP) at 7 weeks [ Time Frame: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 7). ] [ 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:
  • Change from baseline in Maximum Voluntary Ventilation at 7 weeks [ Time Frame: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 7). ] [ 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.


Enrollment: 71
Study Start Date: November 2008
Study Completion Date: February 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Usual care
Experimental: Threshold Inspiratory Muscle Training
Inspiratory muscle training regime
 Device: Threshold® Inspiratory Muscle Trainer (Respironics® Health Scan Inc. Cedar Grove, NJ, USA).
Interval-based program consisting of seven cycles of 2-minutes work and 1-minute rest. The sessions took place 5 times per week over a six-week period for a total of 30 sessions. All participants were familiarized with the breathing exercises over a two-day familiarization period at the beginning of the protocol.
Other Name: Threshold IMT
Experimental: Controlled breathing exercises
Yoga Pranayama breathing exercises
 Other: Yoga Pranayama breathing exercises
Interval-based program. The sessions took place 5 times per week over a six-week period for a total of 30 sessions. All participants were familiarized with the breathing exercises over a two-day familiarization period at the beginning of the protocol.
Other Name: Pranayama

Detailed Description:

Studies have shown that general aerobic exercise training is accompanied by significant respiratory physiological benefits, including gains in RM strength and endurance (Larson, et al., 1999; Sheel, 2002; Watsford, et al., 2005; Lacasse et al., 2006). This benefit appears to be greater when general exercise conditioning is combined with specific RM training (Weiner, et al., 1992; Wanke, et al., 1994; Larson, et al., 1999; Hill y Eastwood, 2005; O'Brien, et al., 2008). However, many frail elderly are not able to perform general aerobic exercise, related or not to ADL, as it is mentioned above (e.g., institutionalized elderly with comorbidities, functional impairment and RM weakness). In this case, specific RM training may be used as a beneficial alternative to maintain or improve RM function (Watsford and Murphy, 2008), and thus prevent deterioration in this functionally impaired elderly.

The most commonly used techniques of specific RM training are: a) isocapnic hyperpnoea (Leith and Bradley, 1976; Belman and Mittman, 1980), b) respiratory resistive loading (Pardy, et al., 1981; Sonne and Davis, 1982; Belman, et al., 1986), and c) respiratory threshold loading (Clanton, et al., 1985; Chen, et al., 1985; Martyn, et al., 1987; Larson, et al., 1988). Apart from these three well-known techniques, other less studied types of exercise such as the controlled breathing exercises of Yoga, Pranayama, may also be added to this list (Kulpati, et al., 1982; Manocha, et al., 2002; Donesky-Cueco, et al., 2009).

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinically stable residents, institutionalized at least 1 year;
  • Barthel Index less than 95 points;
  • inability to independently walk more than 10 meters or inability to effectively use a wheelchair;
  • Mini-Mental Status Examination score of at least 20 points (i.e., subjects without moderate or severe cognitive deterioration).

Exclusion Criteria:

  • significant chronic cardiorespiratory diagnoses (e.g. moderate-severe COPD);
  • an acute cardiorespiratory episode during the last 2 months prior to the study;
  • neurological, muscular, or neuromuscular problems interfering with the capacity to engage in the tests and training protocols;
  • active smokers or former smokers who had stopped smoking less than 5 years ago;
  • a terminal disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624272

Locations
Spain
Residencia de la Tercera Edad "San Luis"
Moncada, Comunidad Valenciana, Spain, 46113
Residencia de la Tercera Edad "El Amparo"
Quart de Poblet, Comunidad Valenciana, Spain, 46930
Ballesol- Centros residenciales 3ª edad
Valencia, Comunidad Valenciana, Spain, 46003
Sponsors and Collaborators
University of Valencia
Investigators
Principal Investigator: M. Àngels Cebrià i Iranzo, PT, PhD University of Valencia
Study Chair: David A Arnall, PT, PhD East Tennessee State University
Study Chair: Celedonia Igual Camacho, PT, PhD University of Valencia
Study Chair: José M Tomás, PhD University of Valencia
  More Information

No publications provided

Responsible Party: Maria dels Angels Cebria i Iranzo, PT, PhD, Assistant Professor Rehabilitation Sciences, University of Valencia
ClinicalTrials.gov Identifier: NCT01624272     History of Changes
Other Study ID Numbers: H1325072291220
Study First Received: June 13, 2012
Last Updated: June 22, 2012
Health Authority: Spain: University of Valencia Ethics Committee.

Keywords provided by University of Valencia:
Physical Therapy
Respiratory Muscle Training
Elderly

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 21, 2013