Effects and Costs of Respiratory Muscle Training in Institutionalized Elderly People

NCT ID: NCT01759992

Last Updated: 2014-03-20

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

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-12-31

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 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.

Detailed Description

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Conditions

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Muscle Weakness Syndrome; Institutionalization Respiratory Morbidity Cardiovascular Morbidity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control group

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Threshold® Inspiratory Muscle Trainer (treatment).

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Respironics® Health Scan Inc. Cedar Grove, NJ, USA

Eligibility Criteria

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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
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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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M. Àngels Cebrià i Iranzo, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

M. Ángeles Tortosa Chuliá, PhD

Role: STUDY_CHAIR

University of Valencia

Celedonia Igual Camacho, PT, PhD

Role: STUDY_CHAIR

University of Valencia

Laura López Bueno, PT, PhD

Role: STUDY_CHAIR

University of Valencia

Locations

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Grupo Gero Residencias "La Saleta"

Valencia, Valencia, Spain

Site Status

Countries

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Spain

References

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Geddes EL, O'Brien K, Reid WD, Brooks D, Crowe J. Inspiratory muscle training in adults with chronic obstructive pulmonary disease: an update of a systematic review. Respir Med. 2008 Dec;102(12):1715-29. doi: 10.1016/j.rmed.2008.07.005. Epub 2008 Aug 15.

Reference Type BACKGROUND
PMID: 18708282 (View on PubMed)

Gorzoni ML, Pires SL. [Long-term care elderly residents in general hospitals]. Rev Saude Publica. 2006 Dec;40(6):1124-30. doi: 10.1590/s0034-89102006000700024. Portuguese.

Reference Type BACKGROUND
PMID: 17173173 (View on PubMed)

Gosselink R, De Vos J, van den Heuvel SP, Segers J, Decramer M, Kwakkel G. Impact of inspiratory muscle training in patients with COPD: what is the evidence? Eur Respir J. 2011 Feb;37(2):416-25. doi: 10.1183/09031936.00031810.

Reference Type BACKGROUND
PMID: 21282809 (View on PubMed)

Rydwik E, Frandin K, Akner G. Physical training in institutionalized elderly people with multiple diagnoses--a controlled pilot study. Arch Gerontol Geriatr. 2005 Jan-Feb;40(1):29-44. doi: 10.1016/j.archger.2004.05.009.

Reference Type BACKGROUND
PMID: 15531021 (View on PubMed)

Simoes RP, Castello V, Auad MA, Dionisio J, Mazzonetto M. Prevalence of reduced respiratory muscle strength in institutionalized elderly people. Sao Paulo Med J. 2009 May;127(2):78-83. doi: 10.1590/s1516-31802009000200005.

Reference Type BACKGROUND
PMID: 19597682 (View on PubMed)

Watsford M, Murphy A. The effects of respiratory-muscle training on exercise in older women. J Aging Phys Act. 2008 Jul;16(3):245-60. doi: 10.1123/japa.16.3.245.

Reference Type BACKGROUND
PMID: 18660549 (View on PubMed)

Other Identifiers

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H1335803152705

Identifier Type: OTHER

Identifier Source: secondary_id

UV-INV-PRECOMP12-80293

Identifier Type: -

Identifier Source: org_study_id

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