Clinical trial NCT01759992: Effects and Costs of Respiratory Muscle Training in Institutionalized Elderly People
Official title: Determination of the Effects and Costs of Respiratory Muscle Training in Institutionalized Elderly People With Functional Impairment: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Weakness
Syndrome; Institutionalization
Respiratory Morbidity
Cardiovascular Morbidity
Keywords: Frail elderly
Muscle weakness
Institutionalization
Respiratory muscle training
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2013-01-03
Enrollment: 45
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum Inspiratory Pressure (MIP)
timeFrame: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).
measure: Maximum Expiratory Pressure (MEP)
timeFrame: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).
Secondary outcomes:
measure: Maximal Voluntary Ventilation (MVV)
timeFrame: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).
measure: Time performed to walk 10 m distance (10mWT).
timeFrame: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).
measure: Maximal heart rate achieved at the end of the incremental arm ergometry test.
timeFrame: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).
Other outcomes:
measure: Health-related quality-of-life (CRQ).
timeFrame: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).
Locations:
city: Valencia
country: Spain
facility: Grupo Gero Residencias "La Saleta"
Study officials:
affiliation: University of Valencia
name: M. Àngels Cebrià i Iranzo, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Valencia
name: M. Ángeles Tortosa Chuliá, PhD
role: STUDY_CHAIR
affiliation: University of Valencia
name: Celedonia Igual Camacho, PT, PhD
role: STUDY_CHAIR
affiliation: University of Valencia
name: Laura López Bueno, PT, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.