Effects and Costs of Respiratory Muscle Training in Institutionalized Elderly People

Muscle Weakness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01759992
• Other study ID #: UV-INV-PRECOMP12-80293
• Secondary ID: H1335803152705
• Status: Completed
• Phase: N/A
• First received: December 31, 2012
• Last updated: March 18, 2014
• Start date: January 2013
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Spain	Grupo Gero Residencias "La Saleta"	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

References & 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. Review. — View Citation

Gorzoni ML, Pires SL. [Long-term care elderly residents in general hospitals]. Rev Saude Publica. 2006 Dec;40(6):1124-30. Portuguese. — View 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. Review. — View Citation

Rydwik E, Frändin 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. Erratum in: Arch Gerontol Geriatr. 2005 Nov-Dec;41(3):319. Kerstin, Frändin [corrected to Frändin, Kerstin]. — View Citation

Simões RP, Castello V, Auad MA, Dionísio J, Mazzonetto M. Prevalence of reduced respiratory muscle strength in institutionalized elderly people. Sao Paulo Med J. 2009 May;127(2):78-83. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	Yes
Primary	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).	Yes
Primary	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).	Yes
Secondary	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).	Yes
Secondary	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).	Yes
Secondary	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).	Yes