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NCT Number: NCT01759992

Effects and Costs of Respiratory Muscle Training in Institutionalized Elderly People

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.

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Key information

Conditions

Muscle Weakness Cardiovascular Morbidity Disease Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Morbidity Signs and Symptoms Syndrome Syndrome; Institutionalization

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grupo Gero Residencias "La Saleta"

Valencia, 46015, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Respironics® Health Scan Inc. Cedar Grove, NJ, USA

Primary outcomes

  1. 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.

  2. 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

  1. Maximal Voluntary Ventilation (MVV)

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

    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.

  2. Time performed to walk 10 m distance (10mWT).

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

    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.

  3. Maximal heart rate achieved at the end of the incremental arm ergometry test.

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

    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

Other outcomes

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

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

    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.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 3, 2013
Registry last updated
Mar 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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