SarcopeniaNCT02120586
Preventive Physiotherapy Intervention in Elderly People With Sarcopenia
A study testing Inspiratory Muscle Training (IMT). and Peripheral muscle training in people with Sarcopenia and Syndrome; Institutionalization, run by University of Valencia at 1 site in Spain.
Trial summary
This study evaluates two strength training protocols (one in peripheral muscles and one in inspiratory muscles) in the improvement of skeletal muscle mass and function in institutionalized elderly with sarcopenia. Participants will be assigned randomly in a control or one of both experimental groups. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia, Syndrome; Institutionalization
- What is being tested?
- Inspiratory Muscle Training (IMT). and Peripheral muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2014to Jun 2016
- 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
- Sarcopenia diagnosis (Tyrovolas et al., 2015)
- Medically stable at least 2 months before the study
Who cannot join
- Cardiorespiratory, muscular, neurological, or neuromuscular disease that could interfere in the proper performance of assessment and/or training protocols.
- Endocrine and metabolic disorders that might have had an effect on muscle mass.
- Severe disorder of hydration status that could interfere in Bioelectrical Impedance Analysis (Rubbieri et al., 2014).
- A terminal disease diagnosis.
- Mini-Mental State Examination Index ≤ 20 score.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects and Costs of Preventive Physiotherapy Intervention in Institutionalized Elderly People With Sarcopenia: A Randomized Controlled Trial
This study evaluates two strength training protocols (one in peripheral muscles and one in inspiratory muscles) in the improvement of skeletal muscle mass and function in institutionalized elderly with sarcopenia. Participants will be assigned randomly in a control or one of both experimental groups.
Read the detailed description
Sarcopenia is a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength with a risk of adverse outcomes such as physical disability, poor quality of life and death (Goodpaster et al, 2006; Delmonico et al, 2007). The contributing factors are those related to aging process, non-optimal diet, bed rest or sedentary lifestyle, chronic diseases and certain drug treatments. Most of these factors are present in the older population with comorbidity, frequently institutionalized to receive a professional long-term care.
Since the European Working Group on Sarcopenia in Older People (Cruz-Jentoft et al, 2010) recommends using the presence of both low muscle mass and low muscle function (strength and/or physical performance) for the diagnosis of sarcopenia, interventions should be focused in both criteria. The aim of this study is to prevent loss of skeletal muscle mass and strength in institutionalized elderly with sarcopenia.
To this purpose, the investigators study undertakes two physiotherapy interventions to preventing/treating Sarcopenia, namely, maintenance of muscle mass and improvement of strength in peripheral and respiratory muscles. Both interventions are common in the following features: supervision, duration, frequency and intensity of the training program.
The primary outcomes are those related to muscle mass and strength. Secondary outcomes will be related to muscle function (muscle endurance and/or physical performance), costs and health status (number of falls and fractures, exacerbations of chronic diseases, hospitalizations and deaths during the year after concluding the physiotherapy interventions).
- Conditions
- Sarcopenia, Syndrome; Institutionalization
- Being tested
- Inspiratory Muscle Training (IMT)., Peripheral muscle training
- Keywords
- Elderly, Institutionalization, Sarcopenia, Strength training, Muscle mass, Muscle strength, Physical performance
- Medical subject headings
- Sarcopenia, Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle Training (IMT).Other
Also called Threshold IMT (Respironics Health Inc. Cedar Grove, NJ, USA)
Supervised interval-based program consisting of seven cycles of 2-minutes work and 1-minute rest. This protocol is published as a practical guide for clinicians by Hill et al (2010).
The sessions will take place 3 times per week over a twelve-week period for a total of 36 sessions. All participants will be 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. Participants remain seated in groups of 8 to 10.
Peripheral muscle trainingOther
The supervised training program consists of one cycle of 10 exercises, 12 repetitions each one. The main peripheral muscles to be trained will be those recommended by Cruz-Jentoft et al (2011): brachial biceps and triceps, pectorals, deltoid, hand flexors and extensors, spine extensor muscles, psoas-iliac, quadriceps femoris and sural triceps.
The sessions will take place 3 times per week over a twelve-week period for a total of 36 sessions. All participants were familiarized with the force exercises over a two-week familiarization period at the beginning of the protocol. The load will be adjusted at ≥ 50% of maximum muscle force. Participants remain seated in groups of 8 to 10.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Usual care |
| Respiratory training 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.
Intervention: Inspiratory Muscle training (12-weeks) Receives: Other: Inspiratory Muscle Training (IMT). |
| Peripheral training group | Experimental | Participants will load ≥ 50% of their maximum muscle force (Kg), after which load 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: Peripheral muscle training (12-weeks) Receives: Other: Peripheral muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Muscle mass
Bioimpedance analysis (BIA) estimates the volume of fat and lean body mass. The test itself is inexpensive, easy to use, readily reproducible and appropriate for both ambulatory and bedridden patients. Reference: J Aging Phys Act 2015;23(4):597-606. Korean J Intern Med 2016;31:643-650.
Measured: The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
Change in Maximum Respiratory Pressures (MIP and MEP)
MIP and MEP are probably the most frequently reported non-invasive estimates of respiratory 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 breathing. Reference: Am J Respir Crit Care Med. 2002;166:531-535.
Measured: The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
Change in Handgrip strength
Isometric hand grip strength is strongly related with lower extremity muscle power, knee extension torque and calf cross-sectional muscle area. In practice, there is also a linear relationship between baseline handgrip strength and incident disability for activities of daily living. Reference: Age and Aging. 2010;39:412-423.
Measured: The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
Change in peripheral muscle strength
Maximal isometric muscle strength (Kg) was assessed for knee extension (Quadriceps femoris) and elbow flexion (Biceps brachii). Reference: J Am Geriatr Soc 2002; 50: 461-7.
Measured: The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
Secondary outcomes (2)
Change in 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 will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
Change in Time performed to walk 10 m distance (10mWT).
The 10-Meter Walk Test (10mWT) is a measure of gait speed (measurement of physical performance). 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: Phys Ther. 2010;90(2):196-208.
Measured: The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 91 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
- Maria A Cebrià i Iranzo, PT, PhD, Principal investigator, University of ValenciaMaría A Tortosa Chuliá, PhD, Study chair, University of ValenciaMaría J Ponce Darós, PT, PhD, Study chair, University of ValenciaMercè Balasch i Bernat, PT, PhD, Study chair, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120586
- Sponsor's protocol ID
- H1382044172319
- Other IDs
- H1382044172319
- Status last verified
- Jul 2017
- First submitted
- 16 Apr 2014
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Results are published in a J Aging Phys Act. 2018. 1;26(4):637-646.
Publications
Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
PubMed 20392703Cruz-Jentoft AJ, Triana FC, Gomez-Cabrera MC, Lopez-Soto A, Masanes F, Martin PM, Rexach JA, Hidalgo DR, Salva A, Vina J, Formiga F. [The emergent role of sarcopenia: Preliminary Report of the Observatory of Sarcopenia of the Spanish Society of Geriatrics and Gerontology]. Rev Esp Geriatr Gerontol. 2011 Mar-Apr;46(2):100-10. doi: 10.1016/j.regg.2010.11.004. Epub 2011 Jan 8. Spanish.
PubMed 21216498Doherty TJ. Invited review: Aging and sarcopenia. J Appl Physiol (1985). 2003 Oct;95(4):1717-27. doi: 10.1152/japplphysiol.00347.2003.
PubMed 12970377Tyrovolas S, Koyanagi A, Olaya B, Ayuso-Mateos JL, Miret M, Chatterji S, Tobiasz-Adamczyk B, Koskinen S, Leonardi M, Haro JM. The role of muscle mass and body fat on disability among older adults: A cross-national analysis. Exp Gerontol. 2015 Sep;69:27-35. doi: 10.1016/j.exger.2015.06.002. Epub 2015 Jun 3.
PubMed 26048566
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Costs of Preventive Physiotherapy Intervention in Institutionalized Elderly People With Sarcopenia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02120586
- Acronym / sponsor ID
- H1382044172319
- Conditions
- Sarcopenia, Syndrome; Institutionalization
- Keywords
- Elderly, Institutionalization, Sarcopenia, Strength training, Muscle mass, Muscle strength, Physical performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 23 Apr 2014 (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.
This study evaluates two strength training protocols (one in peripheral muscles and one in inspiratory muscles) in the improvement of skeletal muscle mass and function in institutionalized elderly with sarcopenia. Participants will be assigned randomly in a control or one of both experimental groups.
Detailed description
Sarcopenia is a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength with a risk of adverse outcomes such as physical disability, poor quality of life and death (Goodpaster et al, 2006; Delmonico et al, 2007). The contributing factors are those related to aging process, non-optimal diet, bed rest or sedentary lifestyle, chronic diseases and certain drug treatments. Most of these factors are present in the older population with comorbidity, frequently institutionalized to receive a professional long-term care.
Since the European Working Group on Sarcopenia in Older People (Cruz-Jentoft et al, 2010) recommends using the presence of both low muscle mass and low muscle function (strength and/or physical performance) for the diagnosis of sarcopenia, interventions should be focused in both criteria. The aim of this study is to prevent loss of skeletal muscle mass and strength in institutionalized elderly with sarcopenia.
To this purpose, the investigators study undertakes two physiotherapy interventions to preventing/treating Sarcopenia, namely, maintenance of muscle mass and improvement of strength in peripheral and respiratory muscles. Both interventions are common in the following features: supervision, duration, frequency and intensity of the training program.
The primary outcomes are those related to muscle mass and strength. Secondary outcomes will be related to muscle function (muscle endurance and/or physical performance), costs and health status (number of falls and fractures, exacerbations of chronic diseases, hospitalizations and deaths during the year after concluding the physiotherapy interventions).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Usual care |
| Respiratory training group | Experimental | Other: Inspiratory Muscle Training (IMT).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: Inspiratory Muscle training (12-weeks) |
| Peripheral training group | Experimental | Other: Peripheral muscle trainingParticipants will load ≥ 50% of their maximum muscle force (Kg), after which load 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: Peripheral muscle training (12-weeks) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- People aged > 65 years
- Sarcopenia diagnosis (Tyrovolas et al., 2015)
- Medically stable at least 2 months before the study
Key exclusion criteria (5 listed)
- Cardiorespiratory, muscular, neurological, or neuromuscular disease that could interfere in the proper performance of assessment and/or training protocols.
- Endocrine and metabolic disorders that might have had an effect on muscle mass.
- Severe disorder of hydration status that could interfere in Bioelectrical Impedance Analysis (Rubbieri et al., 2014).
- A terminal disease diagnosis.
- Mini-Mental State Examination Index ≤ 20 score.
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 |
|---|---|---|
| Inspiratory Muscle Training (IMT).Also: Threshold IMT (Respironics Health Inc. Cedar Grove, NJ, USA)Supervised interval-based program consisting of seven cycles of 2-minutes work and 1-minute rest. This protocol is published as a practical guide for clinicians by Hill et al (2010). The sessions will take place 3 times per week over a twelve-week period for a total of 36 sessions. All participants will be 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. Participants remain seated in groups of 8 to 10. | Other | Respiratory training group |
| Peripheral muscle trainingThe supervised training program consists of one cycle of 10 exercises, 12 repetitions each one. The main peripheral muscles to be trained will be those recommended by Cruz-Jentoft et al (2011): brachial biceps and triceps, pectorals, deltoid, hand flexors and extensors, spine extensor muscles, psoas-iliac, quadriceps femoris and sural triceps. The sessions will take place 3 times per week over a twelve-week period for a total of 36 sessions. All participants were familiarized with the force exercises over a two-week familiarization period at the beginning of the protocol. The load will be adjusted at ≥ 50% of maximum muscle force. Participants remain seated in groups of 8 to 10. | Other | Peripheral training group |
Primary outcome
Change in Muscle mass
Time frame: The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
Bioimpedance analysis (BIA) estimates the volume of fat and lean body mass. The test itself is inexpensive, easy to use, readily reproducible and appropriate for both ambulatory and bedridden patients. Reference: J Aging Phys Act 2015;23(4):597-606. Korean J Intern Med 2016;31:643-650.
Change in Maximum Respiratory Pressures (MIP and MEP)
Time frame: The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
MIP and MEP are probably the most frequently reported non-invasive estimates of respiratory 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 breathing. Reference: Am J Respir Crit Care Med. 2002;166:531-535.
Change in Handgrip strength
Time frame: The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
Isometric hand grip strength is strongly related with lower extremity muscle power, knee extension torque and calf cross-sectional muscle area. In practice, there is also a linear relationship between baseline handgrip strength and incident disability for activities of daily living. Reference: Age and Aging. 2010;39:412-423.
Change in peripheral muscle strength
Time frame: The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
Maximal isometric muscle strength (Kg) was assessed for knee extension (Quadriceps femoris) and elbow flexion (Biceps brachii). Reference: J Am Geriatr Soc 2002; 50: 461-7.
2 secondary outcomes
Change in Maximal Voluntary Ventilation (MVV)
Time frame: The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
Change in Time performed to walk 10 m distance (10mWT).
Time frame: The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).
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 15 Nov 2018.
- Background: PubMed 20392703Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
- Background: PubMed 21216498Cruz-Jentoft AJ, Triana FC, Gomez-Cabrera MC, Lopez-Soto A, Masanes F, Martin PM, Rexach JA, Hidalgo DR, Salva A, Vina J, Formiga F. [The emergent role of sarcopenia: Preliminary Report of the Observatory of Sarcopenia of the Spanish Society of Geriatrics and Gerontology]. Rev Esp Geriatr Gerontol. 2011 Mar-Apr;46(2):100-10. doi: 10.1016/j.regg.2010.11.004. Epub 2011 Jan 8. Spanish.
- Background: PubMed 12970377Doherty TJ. Invited review: Aging and sarcopenia. J Appl Physiol (1985). 2003 Oct;95(4):1717-27. doi: 10.1152/japplphysiol.00347.2003.
- Background: PubMed 26048566Tyrovolas S, Koyanagi A, Olaya B, Ayuso-Mateos JL, Miret M, Chatterji S, Tobiasz-Adamczyk B, Koskinen S, Leonardi M, Haro JM. The role of muscle mass and body fat on disability among older adults: A cross-national analysis. Exp Gerontol. 2015 Sep;69:27-35. doi: 10.1016/j.exger.2015.06.002. Epub 2015 Jun 3.
- Individual participant dataSharing planned: Yes. Results are published in a J Aging Phys Act. 2018. 1;26(4):637-646.
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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.
Maria A Cebrià i Iranzo, PT, PhD principal investigator
University of Valencia
María A Tortosa Chuliá, PhD study chair
University of Valencia
María J Ponce Darós, 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 Inspiratory Muscle Training (IMT). and Peripheral muscle training in people with Sarcopenia 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 3 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 15 Nov 2018. 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?
Change in Muscle mass (time frame: The groups will be assessed at baseline (pre-intervention) and at the end of the training program (week 12, post-intervention).). The study lists 4 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 NCT02120586, which also lists 4 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 15 Nov 2018.