Respiratory Muscle Training in Institutionalized Elderly Population

Muscle Weakness Clinical Trial

Official title:

The Effectiveness of Pranayama Breathing Exercises vs. Threshold Inspiratory Muscle Trainer to Improve Respiratory Muscle Function in an Institutionalized Frail Elderly Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01624272
• Other study ID #: H1325072291220
• Status: Completed
• Phase: N/A
• First received: June 13, 2012
• Last updated: March 23, 2014
• Start date: November 2008
• Est. completion date: February 2010

Study information

• Verified date: March 2014
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: University of Valencia 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 frail elderly. Respiratory function can be severely compromised if there is a decrease of respiratory (RM) strength complicated by the presence of comorbidities and physical immobility.

Previous studies have shown that the specific RM training is an effective method to increase RM strength, both in healthy people and patients. In this case, specific RM training may be regarded as a beneficial alternative to improve RM function, and thus prevent physical and clinical deterioration in this population.

The hypothesis is that specific RM training would improve RM strength and endurance in the experimental groups vs. control who do not participate in RM training.

Institutionalized elderly people with an inability to walk were randomly allocated to a control group, a Threshold group or a Pranayama group. Both experimental groups performed a supervised RM training, five days a week for six consecutive weeks. The maximum inspiratory and expiratory pressures (MIP and MEP) and the maximum voluntary ventilation (MVV) were assessed at four time points in each of three groups.

Description:

Studies have shown that general aerobic exercise training is accompanied by significant respiratory physiological benefits, including gains in RM strength and endurance (Larson, et al., 1999; Sheel, 2002; Watsford, et al., 2005; Lacasse et al., 2006). This benefit appears to be greater when general exercise conditioning is combined with specific RM training (Weiner, et al., 1992; Wanke, et al., 1994; Larson, et al., 1999; Hill y Eastwood, 2005; O'Brien, et al., 2008). However, many frail elderly are not able to perform general aerobic exercise, related or not to ADL, as it is mentioned above (e.g., institutionalized elderly with comorbidities, functional impairment and RM weakness). In this case, specific RM training may be used as a beneficial alternative to maintain or improve RM function (Watsford and Murphy, 2008), and thus prevent deterioration in this functionally impaired elderly.

The most commonly used techniques of specific RM training are: a) isocapnic hyperpnoea (Leith and Bradley, 1976; Belman and Mittman, 1980), b) respiratory resistive loading (Pardy, et al., 1981; Sonne and Davis, 1982; Belman, et al., 1986), and c) respiratory threshold loading (Clanton, et al., 1985; Chen, et al., 1985; Martyn, et al., 1987; Larson, et al., 1988). Apart from these three well-known techniques, other less studied types of exercise such as the controlled breathing exercises of Yoga, Pranayama, may also be added to this list (Kulpati, et al., 1982; Manocha, et al., 2002; Donesky-Cueco, et al., 2009).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: February 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• clinically stable residents, institutionalized at least 1 year;

• Barthel Index less than 95 points;

• inability to independently walk more than 10 meters or inability to effectively use a wheelchair;

• Mini-Mental Status Examination score of at least 20 points (i.e., subjects without moderate or severe cognitive deterioration).

Exclusion Criteria:

• significant chronic cardiorespiratory diagnoses (e.g. moderate-severe COPD);

• an acute cardiorespiratory episode during the last 2 months prior to the study;

• neurological, muscular, or neuromuscular problems interfering with the capacity to engage in the tests and training protocols;

• active smokers or former smokers who had stopped smoking less than 5 years ago;

• a terminal disease.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Weakness
• Other Diagnoses, Comorbidities, and Complications
• Paresis
• Syndrome; Institutionalization

Intervention

Device:
• Threshold® Inspiratory Muscle Trainer (Respironics® Health Scan Inc. Cedar Grove, NJ, USA).
Interval-based program consisting of seven cycles of 2-minutes work and 1-minute rest. The sessions took place 5 times per week over a six-week period for a total of 30 sessions. All participants were familiarized with the breathing exercises over a two-day familiarization period at the beginning of the protocol.

Other:
• Yoga Pranayama breathing exercises
Interval-based program. The sessions took place 5 times per week over a six-week period for a total of 30 sessions. All participants were familiarized with the breathing exercises over a two-day familiarization period at the beginning of the protocol.

Locations

Country	Name	City	State
Spain	Residencia de la Tercera Edad "San Luis"	Moncada	Comunidad Valenciana
Spain	Residencia de la Tercera Edad "El Amparo"	Quart de Poblet	Comunidad Valenciana
Spain	Ballesol- Centros residenciales 3ª edad	Valencia	Comunidad Valenciana

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Cebrià I Iranzo MD, Arnall DA, Igual Camacho C, Tomás JM, Meléndez JC. Physiotherapy intervention for preventing the respiratory muscle deterioration in institutionalized older women with functional impairment. Arch Bronconeumol. 2013 Jan;49(1):1-9. doi: — View Citation

Cebrià i Iranzo Md, Arnall DA, Igual Camacho C, Tomás JM. Effects of inspiratory muscle training and yoga breathing exercises on respiratory muscle function in institutionalized frail older adults: a randomized controlled trial. J Geriatr Phys Ther. 2014 — View Citation

Cebrià I Iranzo MD, Tortosa-Chuliá MÁ, Igual-Camacho C, Sancho P, Galiana L, Tomás JM. [Cost-consequence analysis of respiratory preventive intervention among institutionalized older people: randomized controlled trial]. Rev Esp Geriatr Gerontol. 2014 Sep — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Maximum Inspiratory Pressure (MIP) at 7 weeks	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 7).	Yes
Primary	Change from baseline in Maximum Expiratory Pressure (MEP) at 7 weeks	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 7).	Yes
Secondary	Change from baseline in Maximum Voluntary Ventilation at 7 weeks	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 7).	Yes