Clinical trial NCT01624272: Respiratory Muscle Training in Institutionalized Elderly Population
Official title: The Effectiveness of Pranayama Breathing Exercises vs. Threshold Inspiratory Muscle Trainer to Improve Respiratory Muscle Function in an Institutionalized Frail Elderly Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Weakness
Syndrome; Institutionalization
Other Diagnoses, Comorbidities, and Complications
Keywords: Physical Therapy
Respiratory Muscle Training
Elderly
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2012-06-20
Enrollment: 71
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 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Maximum Inspiratory Pressure (MIP) at 7 weeks
timeFrame: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 7).
measure: Change from baseline in Maximum Expiratory Pressure (MEP) at 7 weeks
timeFrame: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 7).
Secondary outcomes:
measure: Change from baseline in Maximum Voluntary Ventilation at 7 weeks
timeFrame: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 7).
Other outcomes:
Locations:
city: Moncada
country: Spain
facility: Residencia de la Tercera Edad "San Luis"
state: Comunidad Valenciana
city: Quart de Poblet
country: Spain
facility: Residencia de la Tercera Edad "El Amparo"
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Ballesol- Centros residenciales 3ª edad
state: Comunidad Valenciana
Study officials:
affiliation: University of Valencia
name: M. Àngels Cebrià i Iranzo, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: East Tennessee State University
name: David A Arnall, PT, PhD
role: STUDY_CHAIR
affiliation: University of Valencia
name: Celedonia Igual Camacho, PT, PhD
role: STUDY_CHAIR
affiliation: University of Valencia
name: José M Tomás, PhD
role: STUDY_CHAIR
References:
citation: Cebria I Iranzo MD, Arnall DA, Igual Camacho C, Tomas JM, Melendez 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: 10.1016/j.arbres.2012.07.007. Epub 2012 Sep 19. English, Spanish.
citation: Cebria i Iranzo Md, Arnall DA, Igual Camacho C, Tomas 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 Apr-Jun;37(2):65-75. doi: 10.1519/JPT.0b013e31829938bb.
citation: Cebria I Iranzo MD, Tortosa-Chulia MA, Igual-Camacho C, Sancho P, Galiana L, Tomas JM. [Cost-consequence analysis of respiratory preventive intervention among institutionalized older people: randomized controlled trial]. Rev Esp Geriatr Gerontol. 2014 Sep-Oct;49(5):203-9. doi: 10.1016/j.regg.2013.11.002. Epub 2014 Jan 11. Spanish.