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Respiratory Muscle Training in Institutionalized Elderly Population

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Threshold® Inspiratory Muscle Trainer (Respironics® Health Scan Inc. Cedar Grove, NJ, USA).
Yoga Pranayama breathing exercises
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Weakness focused on measuring Physical Therapy, Respiratory Muscle Training, Elderly

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Residencia de la Tercera Edad "San Luis"
  • Residencia de la Tercera Edad "El Amparo"
  • Ballesol- Centros residenciales 3ª edad

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Threshold Inspiratory Muscle Training

Controlled breathing exercises

Arm Description

Usual care

Inspiratory muscle training regime

Yoga Pranayama breathing exercises

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 13, 2012
Last Updated
March 23, 2014
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT01624272
Brief Title
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

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness, Syndrome; Institutionalization, Other Diagnoses, Comorbidities, and Complications
Keywords
Physical Therapy, Respiratory Muscle Training, Elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care
Arm Title
Threshold Inspiratory Muscle Training
Arm Type
Experimental
Arm Description
Inspiratory muscle training regime
Arm Title
Controlled breathing exercises
Arm Type
Experimental
Arm Description
Yoga Pranayama breathing exercises
Intervention Type
Device
Intervention Name(s)
Threshold® Inspiratory Muscle Trainer (Respironics® Health Scan Inc. Cedar Grove, NJ, USA).
Other Intervention Name(s)
Threshold IMT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Yoga Pranayama breathing exercises
Other Intervention Name(s)
Pranayama
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in Maximum Inspiratory Pressure (MIP) at 7 weeks
Description
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.
Time Frame
The groups were assessed at baseline (time zero) and at the end of the training protocol (week 7).
Title
Change from baseline in Maximum Expiratory Pressure (MEP) at 7 weeks
Description
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.
Time Frame
The groups were assessed at baseline (time zero) and at the end of the training protocol (week 7).
Secondary Outcome Measure Information:
Title
Change from baseline in Maximum Voluntary Ventilation at 7 weeks
Description
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.
Time Frame
The groups were assessed at baseline (time zero) and at the end of the training protocol (week 7).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Àngels Cebrià i Iranzo, PT, PhD
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David A Arnall, PT, PhD
Organizational Affiliation
East Tennessee State University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Celedonia Igual Camacho, PT, PhD
Organizational Affiliation
University of Valencia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
José M Tomás, PhD
Organizational Affiliation
University of Valencia
Official's Role
Study Chair
Facility Information:
Facility Name
Residencia de la Tercera Edad "San Luis"
City
Moncada
State/Province
Comunidad Valenciana
ZIP/Postal Code
46113
Country
Spain
Facility Name
Residencia de la Tercera Edad "El Amparo"
City
Quart de Poblet
State/Province
Comunidad Valenciana
ZIP/Postal Code
46930
Country
Spain
Facility Name
Ballesol- Centros residenciales 3ª edad
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46003
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
22999331
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.
Results Reference
result
PubMed Identifier
23835773
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.
Results Reference
result
PubMed Identifier
24417971
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.
Results Reference
result

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Respiratory Muscle Training in Institutionalized Elderly Population

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