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Effects and Costs of Respiratory Muscle Training in Institutionalized Elderly People

Primary Purpose

Muscle Weakness, Syndrome; Institutionalization, Respiratory Morbidity

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Threshold® Inspiratory Muscle Trainer (treatment).
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 Frail elderly, Muscle weakness, Institutionalization, Respiratory muscle training

Eligibility Criteria

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

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

Sites / Locations

  • Grupo Gero Residencias "La Saleta"

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Treatment group

Arm Description

Usual care

Participants will breathe against a load ≥ 50% of their baseline MIP, after which loads will increase according to the participant's tolerance across the remaining training period, using a Borg scale rating of 4 to 6 on perceived exertion as an indicator of adequate training intensity.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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

Full Information

First Posted
December 31, 2012
Last Updated
March 18, 2014
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT01759992
Brief Title
Effects and Costs of Respiratory Muscle Training in Institutionalized Elderly People
Official Title
Determination of the Effects and Costs of Respiratory Muscle Training in Institutionalized Elderly People With Functional Impairment: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
December 2013 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness, Syndrome; Institutionalization, Respiratory Morbidity, Cardiovascular Morbidity
Keywords
Frail elderly, Muscle weakness, Institutionalization, Respiratory muscle training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual care
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Participants will breathe against a load ≥ 50% of their baseline MIP, after which loads will increase according to the participant's tolerance across the remaining training period, using a Borg scale rating of 4 to 6 on perceived exertion as an indicator of adequate training intensity.
Intervention Type
Device
Intervention Name(s)
Threshold® Inspiratory Muscle Trainer (treatment).
Other Intervention Name(s)
Respironics® Health Scan Inc. Cedar Grove, NJ, USA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum Inspiratory Pressure (MIP)
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 9).
Title
Maximum Expiratory Pressure (MEP)
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 9).
Secondary Outcome Measure Information:
Title
Maximal Voluntary Ventilation (MVV)
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 9).
Title
Time performed to walk 10 m distance (10mWT).
Description
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.
Time Frame
The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).
Title
Maximal heart rate achieved at the end of the incremental arm ergometry test.
Description
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
Time Frame
The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).
Other Pre-specified Outcome Measures:
Title
Health-related quality-of-life (CRQ).
Description
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.
Time Frame
The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
M. Ángeles Tortosa Chuliá, PhD
Organizational Affiliation
University of Valencia
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
Laura López Bueno, PT, PhD
Organizational Affiliation
University of Valencia
Official's Role
Study Chair
Facility Information:
Facility Name
Grupo Gero Residencias "La Saleta"
City
Valencia
ZIP/Postal Code
46015
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
18708282
Citation
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.
Results Reference
background
PubMed Identifier
17173173
Citation
Gorzoni ML, Pires SL. [Long-term care elderly residents in general hospitals]. Rev Saude Publica. 2006 Dec;40(6):1124-30. doi: 10.1590/s0034-89102006000700024. Portuguese.
Results Reference
background
PubMed Identifier
21282809
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.
Results Reference
background
PubMed Identifier
15531021
Citation
Rydwik E, Frandin 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. doi: 10.1016/j.archger.2004.05.009. Erratum In: Arch Gerontol Geriatr. 2005 Nov-Dec;41(3):319. Kerstin, Frandin [corrected to Frandin, Kerstin].
Results Reference
background
PubMed Identifier
19597682
Citation
Simoes RP, Castello V, Auad MA, Dionisio J, Mazzonetto M. Prevalence of reduced respiratory muscle strength in institutionalized elderly people. Sao Paulo Med J. 2009 May;127(2):78-83. doi: 10.1590/s1516-31802009000200005.
Results Reference
background
PubMed Identifier
18660549
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. doi: 10.1123/japa.16.3.245.
Results Reference
background

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Effects and Costs of Respiratory Muscle Training in Institutionalized Elderly People

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