Effects and Costs of Respiratory Muscle Training in Institutionalized Elderly People

Determination of the Effects and Costs of Respiratory Muscle Training in Institutionalized Elderly People With Functional Impairment: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Muscle Weakness; Cardiovascular Morbidity; Respiratory Morbidity; Syndrome; Institutionalization
• Intervention / Treatment: Device: Threshold® Inspiratory Muscle Trainer (treatment).

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46015
    • Grupo Gero Residencias "La Saleta"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Respironics® Health Scan Inc. Cedar Grove, NJ, USA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Inspiratory Pressure (MIP)	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.	The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).
Maximum Expiratory Pressure (MEP)	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.	The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal Voluntary Ventilation (MVV)	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.	The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).
Time performed to walk 10 m distance (10mWT).	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.	The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).
Maximal heart rate achieved at the end of the incremental arm ergometry test.	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	The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality-of-life (CRQ).	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.	The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).

Collaborators and Investigators

• Sponsor: University of Valencia
• Investigators: Principal Investigator: M. Àngels Cebrià i Iranzo, PT, PhD, University of Valencia; Study Chair: Celedonia Igual Camacho, PT, PhD, University of Valencia; Study Chair: M. Ángeles Tortosa Chuliá, PhD, University of Valencia; Study Chair: Laura López Bueno, PT, PhD, University of Valencia

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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. Erratum In: Arch Gerontol Geriatr. 2005 Nov-Dec;41(3):319. Kerstin, Frandin [corrected to Frandin, Kerstin].
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: December 31, 2012
• First Submitted That Met QC Criteria: December 31, 2012
• First Posted (Estimate): January 3, 2013

Study Record Updates

• Last Update Posted (Estimate): March 20, 2014
• Last Update Submitted That Met QC Criteria: March 18, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Institutionalization; Muscle weakness; Frail elderly; Respiratory muscle training
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness; Paresis
• Other Study ID Numbers: UV-INV-PRECOMP12-80293; H1335803152705 (Other Identifier: University of Valencia Research Ethics Committee)