Effects and Costs of Respiratory Muscle Training in Institutionalized Elderly People

NCT01759992 | Completed

• 2 other identifiers: UV-INV-PRECOMP12-80293H1335803152705
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Muscle Weakness; Syndrome; Institutionalization; Respiratory Morbidity; Cardiovascular Morbidity

Keywords

Frail elderly; Muscle weakness; Institutionalization; Respiratory muscle training

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Maximal Voluntary Ventilation (MVV)

  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 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 groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).

Other Outcomes (1)

• Health-related quality-of-life (CRQ).

  The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).

Study Arms (2)

Control group

NO INTERVENTION

Usual care

Treatment group

EXPERIMENTAL

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).

Interventions

Threshold® Inspiratory Muscle Trainer (treatment). 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.

Also known as: Respironics® Health Scan Inc. Cedar Grove, NJ, USA

Treatment group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• People aged \> 65 years
• Barthel Index \< 75 score
• Mini-mental state examination ≥ 20 score
• Inspiratory muscle weakness (MIP ≤ 30% predicted value)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Grupo Gero Residencias "La Saleta"

Valencia, Valencia, 46015, Spain

Location

Related Publications (6)

• 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.

  PMID: 18708282 BACKGROUND

• 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.

  PMID: 17173173 BACKGROUND

• 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.

  PMID: 21282809 BACKGROUND

• 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.

  PMID: 15531021 BACKGROUND

• 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.

  PMID: 19597682 BACKGROUND

• 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.

  PMID: 18660549 BACKGROUND

MeSH Terms

Conditions

Muscle Weakness; Syndrome

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Disease

Study Officials

• M. Àngels Cebrià i Iranzo, PT, PhD

  University of Valencia

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 31, 2012
• First Posted: January 3, 2013
• Study Start: January 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 20, 2014

Record last verified: 2014-03

Locations

ES (1)