Respiratory Muscle Training in Institutionalized Elderly Population

NCT01624272 | Completed

• 1 other identifier: H1325072291220
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

Physical Therapy; Respiratory Muscle Training; Elderly

Outcome Measures

Primary Outcomes (2)

• 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).

• 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).

Secondary Outcomes (1)

• Change from baseline in Maximum Voluntary Ventilation at 7 weeks

  The groups were assessed at baseline (time zero) and at the end of the training protocol (week 7).

Study Arms (3)

Control

NO INTERVENTION

Usual care

Threshold Inspiratory Muscle Training

EXPERIMENTAL

Inspiratory muscle training regime

Device: Threshold® Inspiratory Muscle Trainer (Respironics® Health Scan Inc. Cedar Grove, NJ, USA).

Controlled breathing exercises

EXPERIMENTAL

Yoga Pranayama breathing exercises

Other: Yoga Pranayama breathing exercises

Interventions

Threshold® Inspiratory Muscle Trainer (Respironics® Health Scan Inc. Cedar Grove, NJ, USA). DEVICE

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.

Also known as: Threshold IMT

Threshold Inspiratory Muscle Training

Yoga Pranayama breathing exercises OTHER

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.

Also known as: Pranayama

Controlled breathing exercises

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (3)

Residencia de la Tercera Edad "San Luis"

Moncada, Valencia, 46113, Spain

Location

Residencia de la Tercera Edad "El Amparo"

Quart de Poblet, Valencia, 46930, Spain

Location

Ballesol- Centros residenciales 3ª edad

Valencia, Valencia, 46003, Spain

Location

Related Publications (3)

• 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.

  PMID: 22999331 RESULT

• 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.

  PMID: 23835773 RESULT

• 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.

  PMID: 24417971 RESULT

MeSH Terms

Conditions

Muscle Weakness; Syndrome

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Disease

Study Officials

• M. Àngels Cebrià i Iranzo, PT, PhD

  University of Valencia

  PRINCIPAL INVESTIGATOR

• David A Arnall, PT, PhD

  East Tennessee State University

  STUDY CHAIR

• Celedonia Igual Camacho, PT, PhD

  University of Valencia

  STUDY CHAIR

• José M Tomás, PhD

  University of Valencia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Rehabilitation Sciences

Study Record Dates

• First Submitted: June 13, 2012
• First Posted: June 20, 2012
• Study Start: November 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: February 1, 2010
• Last Updated: March 26, 2014

Record last verified: 2014-03

Locations

ES (3)