Muscle WeaknessNCT01759992
Effects and Costs of Respiratory Muscle Training in Institutionalized Elderly People
A study testing Threshold® Inspiratory Muscle Trainer (treatment). in people with Muscle Weakness and Syndrome; Institutionalization, run by University of Valencia at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Muscle Weakness, Syndrome; Institutionalization, Respiratory Morbidity
- What is being tested?
- Threshold® Inspiratory Muscle Trainer (treatment).
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- People aged > 65 years
- Barthel Index < 75 score
- Mini-mental state examination ≥ 20 score
- Inspiratory muscle weakness (MIP ≤ 30% predicted value)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Effects and Costs of Respiratory Muscle Training in Institutionalized Elderly People With Functional Impairment: A Randomized Controlled Trial
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.
- Conditions
- Muscle Weakness, Syndrome; Institutionalization, Respiratory Morbidity, Cardiovascular Morbidity
- Being tested
- Threshold® Inspiratory Muscle Trainer (treatment).
- Keywords
- Frail elderly, Muscle weakness, Institutionalization, Respiratory muscle training
- Medical subject headings
- Muscle Weakness, Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Threshold® Inspiratory Muscle Trainer (treatment).Device
Also called 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 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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Usual care |
| Treatment group | Experimental | 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. Receives: Device: Threshold® Inspiratory Muscle Trainer (treatment). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).
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.
Measured: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).
Secondary outcomes (3)
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.
Measured: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).
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.
Measured: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).
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
Measured: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria dels Angels Cebria i Iranzo, PT, PhD, University of Valencia
- Investigators
- M. Àngels Cebrià i Iranzo, PT, PhD, Principal investigator, University of ValenciaM. Ángeles Tortosa Chuliá, PhD, Study chair, University of ValenciaCeledonia Igual Camacho, PT, PhD, Study chair, University of ValenciaLaura López Bueno, PT, PhD, Study chair, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759992
- Sponsor's protocol ID
- UV-INV-PRECOMP12-80293
- Other IDs
- H1335803152705
- Status last verified
- Mar 2014
- First submitted
- 31 Dec 2012
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18708282Gorzoni 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.
PubMed 17173173Gosselink 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.
PubMed 21282809Rydwik 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.
PubMed 15531021Simoes 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.
PubMed 19597682Watsford 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.
PubMed 18660549
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effects and Costs of Respiratory Muscle Training in Institutionalized Elderly People With Functional Impairment: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01759992
- Acronym / sponsor ID
- UV-INV-PRECOMP12-80293
- Conditions
- Muscle Weakness, Syndrome; Institutionalization, Respiratory Morbidity, Cardiovascular Morbidity
- Keywords
- Frail elderly, Muscle weakness, Institutionalization, Respiratory muscle training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Usual care |
| Treatment group | Experimental | Device: Threshold® Inspiratory Muscle Trainer (treatment).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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- People aged > 65 years
- Barthel Index < 75 score
- Mini-mental state examination ≥ 20 score
- Inspiratory muscle weakness (MIP ≤ 30% predicted value)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Threshold® Inspiratory Muscle Trainer (treatment).Also: Respironics® Health Scan Inc. Cedar Grove, NJ, USAInterval-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. | Device | Treatment group |
Primary outcome
Maximum Inspiratory Pressure (MIP)
Time frame: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).
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)
Time frame: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).
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.
3 secondary outcomes
Maximal Voluntary Ventilation (MVV)
Time frame: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).
Time performed to walk 10 m distance (10mWT).
Time frame: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).
Maximal heart rate achieved at the end of the incremental arm ergometry test.
Time frame: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2014.
- Background: PubMed 18708282Geddes 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.
- Background: PubMed 17173173Gorzoni 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.
- Background: PubMed 21282809Gosselink 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.
- Background: PubMed 15531021Rydwik 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.
- Background: PubMed 19597682Simoes 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.
- Background: PubMed 18660549Watsford 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Àngels Cebrià i Iranzo, PT, PhD principal investigator
University of Valencia
M. Ángeles Tortosa Chuliá, PhD study chair
University of Valencia
Celedonia Igual Camacho, PT, PhD study chair
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Threshold® Inspiratory Muscle Trainer (treatment). in people with Muscle Weakness and Syndrome; Institutionalization, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Inspiratory Pressure (MIP) (time frame: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 9).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01759992, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2014.