Muscle WeaknessNCT01624272
Respiratory Muscle Training in Institutionalized Elderly Population
A study testing Threshold® Inspiratory Muscle Trainer (Respironics® Health Scan Inc. Cedar Grove, NJ, USA). and Yoga Pranayama breathing exercises in people with Muscle Weakness and Syndrome; Institutionalization, run by University of Valencia at 3 sites 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 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Muscle Weakness, Syndrome; Institutionalization, Other Diagnoses, Comorbidities, and Complications
- What is being tested?
- Threshold® Inspiratory Muscle Trainer (Respironics® Health Scan Inc. Cedar Grove, NJ, USA). and Yoga Pranayama breathing exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 3 sitesSpain
- Study dates
- Nov 2008to Feb 2010
- 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
- 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).
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Residencia de la Tercera Edad "San Luis"
Moncada, Valencia, 46113
Residencia de la Tercera Edad "El Amparo"
Quart de Poblet, Valencia, 46930
Ballesol- Centros residenciales 3ª edad
Valencia, Valencia, 46003
About this study
Official title: The Effectiveness of Pranayama Breathing Exercises vs. Threshold Inspiratory Muscle Trainer to Improve Respiratory Muscle Function in an Institutionalized Frail Elderly Population
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.
Read more
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.
Read the 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).
- Conditions
- Muscle Weakness, Syndrome; Institutionalization, Other Diagnoses, Comorbidities, and Complications
- Being tested
- Threshold® Inspiratory Muscle Trainer (Respironics® Health Scan Inc. Cedar Grove, NJ, USA)., Yoga Pranayama breathing exercises
- Keywords
- Physical Therapy, Respiratory Muscle Training, Elderly
- 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 (Respironics® Health Scan Inc. Cedar Grove, NJ, USA).Device
Also called Threshold IMT
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.
Yoga Pranayama breathing exercisesOther
Also called Pranayama
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual care |
| Threshold Inspiratory Muscle Training | Experimental | Inspiratory muscle training regime Receives: Device: Threshold® Inspiratory Muscle Trainer (Respironics® Health Scan Inc. Cedar Grove, NJ, USA). |
| Controlled breathing exercises | Experimental | Yoga Pranayama breathing exercises Receives: Other: Yoga Pranayama breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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 7).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startNov 2008
- Primary completionJul 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 71 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 ValenciaDavid A Arnall, PT, PhD, Study chair, East Tennessee State UniversityCeledonia Igual Camacho, PT, PhD, Study chair, University of ValenciaJosé M Tomás, PhD, Study chair, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624272
- Sponsor's protocol ID
- H1325072291220
- Status last verified
- Mar 2014
- First submitted
- 13 Jun 2012
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22999331Cebria 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.
PubMed 23835773Cebria 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.
PubMed 24417971
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Pranayama Breathing Exercises vs. Threshold Inspiratory Muscle Trainer to Improve Respiratory Muscle Function in an Institutionalized Frail Elderly Population
- ClinicalTrials.gov ID
- NCT01624272
- Acronym / sponsor ID
- H1325072291220
- Conditions
- Muscle Weakness, Syndrome; Institutionalization, Other Diagnoses, Comorbidities, and Complications
- Keywords
- Physical Therapy, Respiratory Muscle Training, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 20 Jun 2012 (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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual care |
| Threshold Inspiratory Muscle Training | Experimental | Device: Threshold® Inspiratory Muscle Trainer (Respironics® Health Scan Inc. Cedar Grove, NJ, USA).Inspiratory muscle training regime |
| Controlled breathing exercises | Experimental | Other: Yoga Pranayama breathing exercisesYoga Pranayama breathing exercises |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
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 (Respironics® Health Scan Inc. Cedar Grove, NJ, USA).Also: Threshold IMTInterval-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. | Device | Threshold Inspiratory Muscle Training |
| Yoga Pranayama breathing exercisesAlso: PranayamaInterval-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. | Other | Controlled breathing exercises |
Primary outcome
Change from baseline in Maximum Inspiratory Pressure (MIP) at 7 weeks
Time frame: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 7).
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
Time frame: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 7).
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.
1 secondary outcome
Change from baseline in Maximum Voluntary Ventilation at 7 weeks
Time frame: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 7).
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 26 Mar 2014.
- Results publication: PubMed 22999331Cebria 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 publication: PubMed 23835773Cebria 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 publication: PubMed 24417971Cebria 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.
Related trials for Muscle Weakness
Not yet recruiting
"CORE Training for Musculoskeletal Health: A Study on Adaptive Exercise Protocols"
Core Muscle Weakness, Postural Control Deficit
Recruiting
rTMS for Postoperative Brain Tumor Patients
Brain Tumors, Transcranial Magnetic Stimulation
RecruitingObservational study
Imaging Assessment of Swallowing and Speech Muscles in Inclusion Body Myositis
IBM, Inclusion Body Myositis
Recruiting
Blood Flow Restriction Training in Knee Arthropathy
Knee Arthroscopic Surgery, Arthrogenic Muscle Inhibition
Not yet recruiting
Recurrent Laryngeal Nerve Monitoring During Pediatric Aerodigestive Tract and Cardiac Surgery
Unilateral Vocal Cord Paralysis, Unilateral Vocal Cord Paresis
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
David A Arnall, PT, PhD study chair
East Tennessee State University
Celedonia Igual Camacho, PT, PhD study chair
University of Valencia
3 sites 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 (Respironics® Health Scan Inc. Cedar Grove, NJ, USA). and Yoga Pranayama breathing exercises in people with Muscle Weakness and Syndrome; Institutionalization, run by University of Valencia at 3 sites 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 5 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 26 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 3 sites 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?
Change from baseline in Maximum Inspiratory Pressure (MIP) at 7 weeks (time frame: The groups were assessed at baseline (time zero) and at the end of the training protocol (week 7).). 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 NCT01624272, which also lists 3 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 26 Mar 2014.