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Clinical Trials/NCT01759992
NCT01759992
Completed
Not Applicable

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

University of Valencia1 site in 1 country45 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Muscle Weakness
Sponsor
University of Valencia
Enrollment
45
Locations
1
Primary Endpoint
Maximum Inspiratory Pressure (MIP)
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
December 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maria dels Angels Cebria i Iranzo, PT, PhD

Assistant Professor

University of Valencia

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

Outcomes

Primary Outcomes

Maximum Inspiratory Pressure (MIP)

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

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.

Maximum Expiratory Pressure (MEP)

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

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.

Secondary Outcomes

  • 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).)

Study Sites (1)

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