Respiratory Muscle Training in Institutionalized Elderly Population

NCT ID: NCT01624272

Last Updated: 2014-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-02-28

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Muscle Weakness Syndrome; Institutionalization Other Diagnoses, Comorbidities, and Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Threshold Inspiratory Muscle Training

Inspiratory muscle training regime

Group Type EXPERIMENTAL

Threshold® Inspiratory Muscle Trainer (Respironics® Health Scan Inc. Cedar Grove, NJ, USA).

Intervention Type DEVICE

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.

Controlled breathing exercises

Yoga Pranayama breathing exercises

Group Type EXPERIMENTAL

Yoga Pranayama breathing exercises

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Other Intervention Names

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Threshold IMT Pranayama

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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Maria dels Angels Cebria i Iranzo, PT, PhD

Assistant Professor Rehabilitation Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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M. Àngels Cebrià i Iranzo, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

David A Arnall, PT, PhD

Role: STUDY_CHAIR

East Tennessee State University

Celedonia Igual Camacho, PT, PhD

Role: STUDY_CHAIR

University of Valencia

José M Tomás, PhD

Role: STUDY_CHAIR

University of Valencia

Locations

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Residencia de la Tercera Edad "San Luis"

Moncada, Valencia, Spain

Site Status

Residencia de la Tercera Edad "El Amparo"

Quart de Poblet, Valencia, Spain

Site Status

Ballesol- Centros residenciales 3ª edad

Valencia, Valencia, Spain

Site Status

Countries

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Spain

References

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Cebria I Iranzo MD, Arnall DA, Igual Camacho C, Tomas JM, Melendez JC. Physiotherapy intervention for preventing the respiratory muscle deterioration in institutionalized older women with functional impairment. Arch Bronconeumol. 2013 Jan;49(1):1-9. doi: 10.1016/j.arbres.2012.07.007. Epub 2012 Sep 19. English, Spanish.

Reference Type RESULT
PMID: 22999331 (View on PubMed)

Cebria i Iranzo Md, Arnall DA, Igual Camacho C, Tomas JM. Effects of inspiratory muscle training and yoga breathing exercises on respiratory muscle function in institutionalized frail older adults: a randomized controlled trial. J Geriatr Phys Ther. 2014 Apr-Jun;37(2):65-75. doi: 10.1519/JPT.0b013e31829938bb.

Reference Type RESULT
PMID: 23835773 (View on PubMed)

Cebria I Iranzo MD, Tortosa-Chulia MA, Igual-Camacho C, Sancho P, Galiana L, Tomas JM. [Cost-consequence analysis of respiratory preventive intervention among institutionalized older people: randomized controlled trial]. Rev Esp Geriatr Gerontol. 2014 Sep-Oct;49(5):203-9. doi: 10.1016/j.regg.2013.11.002. Epub 2014 Jan 11. Spanish.

Reference Type RESULT
PMID: 24417971 (View on PubMed)

Other Identifiers

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H1325072291220

Identifier Type: -

Identifier Source: org_study_id

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