SarcopeniaESSENCT03616249
Exercise and the Sleep for the Sarcopenic Elderly
A study testing Sleep and Resistance Exercise in people with Sarcopenia and Sleep, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
International data indicate that approximately 10% of the elderly will be affected by sarcopenia, a multifactorial syndrome that leads to the progressive and generalized loss of mass and muscular strength, leading to a decrease in quality of life, increased physical dependence, fragility, morbidity And mortality. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Sleep, Physical Activity
- What is being tested?
- Sleep and Resistance Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Mar 2017to 10 Dec 2019
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Have controlled
- blood glucose,
- blood pressure
- osteoporosis
- ability to understand and perform the physical performance test batteries
- ability to training protocol safely.
Who cannot join
- Elderly patients who are undergoing pre-treatment for sarcopenia,
- Clinically unstable,
- Present unstable angina,
- Symptomatic arrhythmia (implantable cardioverter defibrillator and pacemaker),
- Abnormal prior exertion test,
- Pulmonary arterial pressure ≥ 50 mmHg,
Show all 11Show fewer
- Chronic obstructive pulmonary disease,
- Intermittent claudication,
- Psychiatric disorder,
- Incapacitates in understanding and performing tests and,
- Incapacitate to performing physical training safely.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resistance Training Improves Sleep Profile of Elderly Sarcopenic Patients: A Randomized Trail
International data indicate that approximately 10% of the elderly will be affected by sarcopenia, a multifactorial syndrome that leads to the progressive and generalized loss of mass and muscular strength, leading to a decrease in quality of life, increased physical dependence, fragility, morbidity And mortality. Parallel to aging, it is well described in the literature that older people present a phase advance, which promotes alteration in the sleep-wake rhythm, as well as reduction of sleep time and quality.
In this sense, two questions need to be answered: Do sarcosis elderly present major changes in sleep-wake rhythm and in sleep parameters when compared to non-sarcopenic elderly? The improvement of sarcopenia through resistance training is also related to the improvement of the sleep-wake rhythm of the sleep parameters. In order to answer these questions, the objective of the project is to evaluate whether sarcopenic individuals present changes in the sleep-wake rhythm and sleep quality at higher levels when compared to non-sarcopenic individuals and whether the benefits of resistance training for sarcopenic individuals are related to Regulation of sleep-wake rhythm and sleep patterns.
Read the detailed description
Both a World Health Organization and the Brazilian Federal Government estimate that there is an abrupt increase in the number of elderly people. Data on approximately 10% of the elderly are affected by sarcopenia, a multifactorial syndrome that leads to the progressive and generalized loss of muscle mass and muscular strength, leading to a decrease in quality of life, increased physical dependence, fragility, morbidity and mortality. Parallel to the aging, well-being in the literature that the elderly present a phase advance, which promotes the change in the sleep-wake rhythm, as well as the reduction of time and sound quality.
However, the view that a sarcophagus has a multifactorial feature sparing attention is for a possible non-sleep-wake rhythm and sleeping patterns of sarcopenic seniors at higher levels that occur in non-sarcopenic elderly. Interestingly, resistance training has often been used as a form of intervention both for the treatment of sarcopenia and for regulating the sleep-wake rhythm and to improve sleep parameters.
In this sense, two questions need to be answered: Do higher sarcopenic individuals have no sleep-wake rhythm and are there no parameters when compared to non-sarcopenic elderly? The improvement of the resistance training analysis is also related to an improvement in the sleep-wake rhythm of the sleep parameters. In order to answer these questions the objective of the project is to evaluate whether elderly sarcophages present the sleep-wake rhythm and sleep quality at higher levels when compared to non-sarcopenic elderly and the benefits of resistance training for sarcopenic individuals related to rhythm regulation Sleep-wake and sleep patterns.
Trained Non-Sarcopenic Elderly Group (GIT), Trained Elderly (GIT), Trained Elderly (GIT), Trained Elderly (ESSENCE) group; Group Elderly Controls No Sarcopenic (GC) and Elderly Group Sarcopenic Controls (GCS). The GIT and GIST groups underwent resisted training above 85% of 1 RM for 12 weeks and the GC and GCS groups will participate in lectures on lifestyle improvement every 15 days but are submitted to the training protocol. All volunteers are evaluated according to sleep objectives and subjects, as well as monitoring levels of anabolic and catabolic endocrine substances, inflammatory profile, body composition, physical and muscular performance of life before, during and after the experimental period
- Conditions
- Sarcopenia, Sleep, Physical Activity
- Being tested
- Sleep, Resistance Exercise
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SleepOther
Initially, all volunteers will undergo the following pre and post-intervention tests: Polysomnography; Actigraphy for 10 days; Maximum exercise test; blood collection; Physical performance evaluation; Assessment of muscle strength, assessment of body composition; And application of questionnaires.
Resistance ExerciseOther
After these procedures, the sarcophagic elderly will Resistance training, will be performed according to the latest positioning of the American College of Sports Medicine for the training of the elderly . The training will last 12 weeks, 3 times / week, with intervals of 48h between the training sessions, which will have a maximum duration of 60min. The periodization of the training will be done in a linear way, in which the volunteers will be submitted to training with 1 series of 12 to 15 repetitions at 60% of 1RM in the first week; In the second week volunteers will train at 70% of 1RM, performing 2 sets of 10 to 12 repetitions; And from the third week to the end of the training period the volunteers will train at 80% of 1RM performing 3 sets of at most 8 replicates and the intervals between sets may range from 60min to 180min. The training load will be readjusted in the 6th week of training from a new 1RM test and the training will be on the same test equipment.
| Study group | Role | What they receive |
|---|---|---|
| Sleep quality | Experimental | To compare if elderly sartcopics present sleep losses at higher levels than non-sarcopenic elderly Receives: Other: Sleep |
| sleep-wake cycle. | Experimental | To compare if elderly sarcopenics present sleep-wake cycle. disorders at higher levels than non-sarcopenic elderly Receives: Other: Sleep |
| Exercise And Sleep quality | Active comparator | Comparing resistance training in the sarcopenician elderly showed improvements in sleep patterns. Receives: Other: Sleep; Other: Resistance Exercise |
| Exercise And sleep-wake cycle. | Active comparator | Comparing resistance training in the elderly with sarcopenia presents better sleep-wake cycle. Receives: Other: Sleep; Other: Resistance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polysomnography
The full polysomnography (PSG) will be performed overnight, using a digital polysomnography equipment and using the criteria indicated by the American Academy of Sleep for sleep staging (N1, N2, and N3), REM sleep, respiratory events, awakenings and periodic movements of the lower limbs.
Measured: Pre-intervention end (12 weeks) intervention
Pitsburgh Sleep Quality Index
It is a self-applicable, easily interpreted instrument that has been extensively applied to several groups of people and collecting information on complaints about sleep, subjective quality of sleep, sleep onset latency, sleep duration, sleep efficiency, sleep disorder, use of sleeping pills and diurnal dysfunctions. Therefore, the sum of the points indicate that the higher the score the worse the quality of sleep, so when the score is less than 5 it will indicate absence of sleep disorders or a good quality of sleep, whereas if the sum is greater than 5 points the indication will be impaired sleep quality and presence of sleep disorders.
Measured: Pre-intervention, 6 and 12 weeks intervention
Evaluation of Sleep-Wake Cycle - Actigraphy
The antidote is a multidirectional accelerometer that can be used to assess the intensity, time of physical activity, the sleep and wake time of an individual over several days for 24 hours.
Along with the actigrated volunteers will fill in a sleep diary during the same periods of use of the actigravo. The data will be analyzed using 1-minute periods in which various sleep parameters such as total sleep time, sleep efficiency, sleep latency, and wake time may also be recorded using Actiware 5.0 software (Philips Respironics) software, from an average sensitivity threshold. To characterize the circadian rhythm profile, the data will be adjusted to the cosine transformed sine model using a least squares nonlinear regression.
Measured: Pre-intervention, 6 and 12 weeks intervention
Biochemical Assessments
For the biochemical analysis, the fasting venous blood will be collected between 07:00 and 10:00 am using EDTA or heparin coated tubes and dried tubes with serum separator. After centrifugation for 15 minutes at 1000xg, serum and plasma will be immediately distributed in small aliquots and frozen at -80°C. After that, glucose, triglycerides, total cholesterol and fractions, total testosterone and cortisol will be analyzed from the competitive enzyme binding technique; growth hormone (GH), insulin-like growth factor 1 (IGF-1), tumor necrosis factor alpha (TNF-α), interleukin-1 receptor antagonist (IL-1ra), interleukin (IL)-6 and IL-10 by the immunoenzymatic assay method (RayBio® ELISA Kits).
Measured: Pre-intervention, 6 and 12 weeks intervention
Short Physical Performance Battery (SPPB) - Brazilian Version
This instrument consists of 3 tests that evaluate: the static balance standing in 3 different positions (side-by-side, semi-tandem stand, tandem stand); the walking speed to be tested using a distance of 4 meters (in a predetermined round trip) and the muscular strength of the lower limbs by means of the movement of getting up and sitting in a chair (5 consecutive and without the help of the upper limbs). All tests will be performed 3x with an interval of 2 minutes (min) between them and the best result will be considered.
Measured: Pre-intervention, 6 and 12 weeks interventionn
Manual Grip Strength Assessment
Hand grip strength will be measured by a maximal isometric test using the Jamar PC5030JI hand dynamometer (Sammons Preston, Bolingbrook, IL, USA). The dominant hand will be positioned on the dynamometer according to the recommendations proposed by the American Society of Hand Therapy . After proper positioning the volunteer can perform 3 attempts of maximum manual grip with intervals that can vary between 30 and 60 seconds (sec)
Measured: Pre-intervention, 6 and 12 weeks intervention
Body composition
For the analysis of body composition, full body scanning was used using the dual energy X-ray absorptiometry technique (DXA; Prodigy equipped with proprietary software version 13.6, GE-Lunar, Madison, WI, USA), which was held at the Exercise Physiology Sector of the Physiology Department of UNIFESP located at the Olympic Center. Height was measured by a stadiometer fixed to the wall and body mass by a properly calibrated digital scale. After these procedures, the volunteers were placed in the supine position following the references of the scanner's collection field. At the end of the scans, the body regions (body segments) were reviewed and only then was the body composition calculated.
Measured: Pre-intervention, 6 and 12 weeks intervention
Secondary outcomes (2)
Epworth Sleepiness Scale
It is a self-administered questionnaire and refers to the chances of napping in other situations of daily life. The possibility of nap is quantified on a scale ranging from zero (0) to three (3), which 0 corresponds to no chance of snoozing and 3 the high possibility of snoozing. When the sum of points is greater than 10 it will be considered as having a high chance of having excessive daytime sleepiness while score above 16 will indicate as having severe somnolence.
Measured: Pre-intervention, 6 and 12 weeks intervention
Insomnia Severity Index
This instruments is used for quantification of severity and for the diagnosis of insomnia based on DSM-IV, assessing recent problems in the beginning and maintenance of sleep, early awakening, interference in daytime activities, concern with sleep problems and satisfaction with their patterns
Measured: Pre-intervention, 6 and 12 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start3 Mar 2017
- Primary completion10 Oct 2018
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- The elderly are initially distributed into two groups. Sarcopenic Group and Non-Sarcopenic Group and . 1) Training group - who will carry out the resistance training for 12 weeks or; 2) control group - who did not participate in the training in the same period.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helton De Sa Souza, Federal University of São Paulo
- Investigators
- Vania D'Almeida, PhD, Study chair, Universidade Federal de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616249
- Sponsor's protocol ID
- 1388065
- Acronym
- ESSE
- Status last verified
- Feb 2020
- First submitted
- 3 May 2017
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Training Improves Sleep Profile of Elderly Sarcopenic Patients: A Randomized Trail
- ClinicalTrials.gov ID
- NCT03616249
- Acronym / sponsor ID
- ESSE / 1388065
- Conditions
- Sarcopenia, Sleep, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 6 Aug 2018 (actual)
- 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.
International data indicate that approximately 10% of the elderly will be affected by sarcopenia, a multifactorial syndrome that leads to the progressive and generalized loss of mass and muscular strength, leading to a decrease in quality of life, increased physical dependence, fragility, morbidity And mortality. Parallel to aging, it is well described in the literature that older people present a phase advance, which promotes alteration in the sleep-wake rhythm, as well as reduction of sleep time and quality.
In this sense, two questions need to be answered: Do sarcosis elderly present major changes in sleep-wake rhythm and in sleep parameters when compared to non-sarcopenic elderly? The improvement of sarcopenia through resistance training is also related to the improvement of the sleep-wake rhythm of the sleep parameters. In order to answer these questions, the objective of the project is to evaluate whether sarcopenic individuals present changes in the sleep-wake rhythm and sleep quality at higher levels when compared to non-sarcopenic individuals and whether the benefits of resistance training for sarcopenic individuals are related to Regulation of sleep-wake rhythm and sleep patterns.
Detailed description
Both a World Health Organization and the Brazilian Federal Government estimate that there is an abrupt increase in the number of elderly people. Data on approximately 10% of the elderly are affected by sarcopenia, a multifactorial syndrome that leads to the progressive and generalized loss of muscle mass and muscular strength, leading to a decrease in quality of life, increased physical dependence, fragility, morbidity and mortality. Parallel to the aging, well-being in the literature that the elderly present a phase advance, which promotes the change in the sleep-wake rhythm, as well as the reduction of time and sound quality.
However, the view that a sarcophagus has a multifactorial feature sparing attention is for a possible non-sleep-wake rhythm and sleeping patterns of sarcopenic seniors at higher levels that occur in non-sarcopenic elderly. Interestingly, resistance training has often been used as a form of intervention both for the treatment of sarcopenia and for regulating the sleep-wake rhythm and to improve sleep parameters.
In this sense, two questions need to be answered: Do higher sarcopenic individuals have no sleep-wake rhythm and are there no parameters when compared to non-sarcopenic elderly? The improvement of the resistance training analysis is also related to an improvement in the sleep-wake rhythm of the sleep parameters. In order to answer these questions the objective of the project is to evaluate whether elderly sarcophages present the sleep-wake rhythm and sleep quality at higher levels when compared to non-sarcopenic elderly and the benefits of resistance training for sarcopenic individuals related to rhythm regulation Sleep-wake and sleep patterns.
Trained Non-Sarcopenic Elderly Group (GIT), Trained Elderly (GIT), Trained Elderly (GIT), Trained Elderly (ESSENCE) group; Group Elderly Controls No Sarcopenic (GC) and Elderly Group Sarcopenic Controls (GCS). The GIT and GIST groups underwent resisted training above 85% of 1 RM for 12 weeks and the GC and GCS groups will participate in lectures on lifestyle improvement every 15 days but are submitted to the training protocol. All volunteers are evaluated according to sleep objectives and subjects, as well as monitoring levels of anabolic and catabolic endocrine substances, inflammatory profile, body composition, physical and muscular performance of life before, during and after the experimental period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The elderly are initially distributed into two groups. Sarcopenic Group and Non-Sarcopenic Group and . 1) Training group - who will carry out the resistance training for 12 weeks or; 2) control group - who did not participate in the training in the same period.
| Arm | Type | Receives |
|---|---|---|
| Sleep quality | Experimental | Other: SleepTo compare if elderly sartcopics present sleep losses at higher levels than non-sarcopenic elderly |
| sleep-wake cycle. | Experimental | Other: SleepTo compare if elderly sarcopenics present sleep-wake cycle. disorders at higher levels than non-sarcopenic elderly |
| Exercise And Sleep quality | Active comparator | Other: Sleep, Other: Resistance ExerciseComparing resistance training in the sarcopenician elderly showed improvements in sleep patterns. |
| Exercise And sleep-wake cycle. | Active comparator | Other: Sleep, Other: Resistance ExerciseComparing resistance training in the elderly with sarcopenia presents better sleep-wake cycle. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Have controlled
- blood glucose,
- blood pressure
- osteoporosis
- ability to understand and perform the physical performance test batteries
Key exclusion criteria (11 listed)
- Elderly patients who are undergoing pre-treatment for sarcopenia,
- Clinically unstable,
- Present unstable angina,
- Symptomatic arrhythmia (implantable cardioverter defibrillator and pacemaker),
- Abnormal prior exertion test,
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 |
|---|---|---|
| SleepInitially, all volunteers will undergo the following pre and post-intervention tests: Polysomnography; Actigraphy for 10 days; Maximum exercise test; blood collection; Physical performance evaluation; Assessment of muscle strength, assessment of body composition; And application of questionnaires. | Other | Exercise And Sleep quality, Exercise And sleep-wake cycle., Sleep quality, sleep-wake cycle. |
| Resistance ExerciseAfter these procedures, the sarcophagic elderly will Resistance training, will be performed according to the latest positioning of the American College of Sports Medicine for the training of the elderly . The training will last 12 weeks, 3 times / week, with intervals of 48h between the training sessions, which will have a maximum duration of 60min. The periodization of the training will be done in a linear way, in which the volunteers will be submitted to training with 1 series of 12 to 15 repetitions at 60% of 1RM in the first week; In the second week volunteers will train at 70% of 1RM, performing 2 sets of 10 to 12 repetitions; And from the third week to the end of the training period the volunteers will train at 80% of 1RM performing 3 sets of at most 8 replicates and the intervals between sets may range from 60min to 180min. The training load will be readjusted in the 6th week of training from a new 1RM test and the training will be on the same test equipment. | Other | Exercise And Sleep quality, Exercise And sleep-wake cycle. |
Primary outcome
Polysomnography
Time frame: Pre-intervention end (12 weeks) intervention
The full polysomnography (PSG) will be performed overnight, using a digital polysomnography equipment and using the criteria indicated by the American Academy of Sleep for sleep staging (N1, N2, and N3), REM sleep, respiratory events, awakenings and periodic movements of the lower limbs.
Pitsburgh Sleep Quality Index
Time frame: Pre-intervention, 6 and 12 weeks intervention
It is a self-applicable, easily interpreted instrument that has been extensively applied to several groups of people and collecting information on complaints about sleep, subjective quality of sleep, sleep onset latency, sleep duration, sleep efficiency, sleep disorder, use of sleeping pills and diurnal dysfunctions. Therefore, the sum of the points indicate that the higher the score the worse the quality of sleep, so when the score is less than 5 it will indicate absence of sleep disorders or a good quality of sleep, whereas if the sum is greater than 5 points the indication will be impaired sleep quality and presence of sleep disorders.
Evaluation of Sleep-Wake Cycle - Actigraphy
Time frame: Pre-intervention, 6 and 12 weeks intervention
The antidote is a multidirectional accelerometer that can be used to assess the intensity, time of physical activity, the sleep and wake time of an individual over several days for 24 hours. Along with the actigrated volunteers will fill in a sleep diary during the same periods of use of the actigravo. The data will be analyzed using 1-minute periods in which various sleep parameters such as total sleep time, sleep efficiency, sleep latency, and wake time may also be recorded using Actiware 5.0 software (Philips Respironics) software, from an average sensitivity threshold. To characterize the circadian rhythm profile, the data will be adjusted to the cosine transformed sine model using a least squares nonlinear regression.
Biochemical Assessments
Time frame: Pre-intervention, 6 and 12 weeks intervention
For the biochemical analysis, the fasting venous blood will be collected between 07:00 and 10:00 am using EDTA or heparin coated tubes and dried tubes with serum separator. After centrifugation for 15 minutes at 1000xg, serum and plasma will be immediately distributed in small aliquots and frozen at -80°C. After that, glucose, triglycerides, total cholesterol and fractions, total testosterone and cortisol will be analyzed from the competitive enzyme binding technique; growth hormone (GH), insulin-like growth factor 1 (IGF-1), tumor necrosis factor alpha (TNF-α), interleukin-1 receptor antagonist (IL-1ra), interleukin (IL)-6 and IL-10 by the immunoenzymatic assay method (RayBio® ELISA Kits).
Short Physical Performance Battery (SPPB) - Brazilian Version
Time frame: Pre-intervention, 6 and 12 weeks interventionn
This instrument consists of 3 tests that evaluate: the static balance standing in 3 different positions (side-by-side, semi-tandem stand, tandem stand); the walking speed to be tested using a distance of 4 meters (in a predetermined round trip) and the muscular strength of the lower limbs by means of the movement of getting up and sitting in a chair (5 consecutive and without the help of the upper limbs). All tests will be performed 3x with an interval of 2 minutes (min) between them and the best result will be considered.
Manual Grip Strength Assessment
Time frame: Pre-intervention, 6 and 12 weeks intervention
Hand grip strength will be measured by a maximal isometric test using the Jamar PC5030JI hand dynamometer (Sammons Preston, Bolingbrook, IL, USA). The dominant hand will be positioned on the dynamometer according to the recommendations proposed by the American Society of Hand Therapy . After proper positioning the volunteer can perform 3 attempts of maximum manual grip with intervals that can vary between 30 and 60 seconds (sec)
Body composition
Time frame: Pre-intervention, 6 and 12 weeks intervention
For the analysis of body composition, full body scanning was used using the dual energy X-ray absorptiometry technique (DXA; Prodigy equipped with proprietary software version 13.6, GE-Lunar, Madison, WI, USA), which was held at the Exercise Physiology Sector of the Physiology Department of UNIFESP located at the Olympic Center. Height was measured by a stadiometer fixed to the wall and body mass by a properly calibrated digital scale. After these procedures, the volunteers were placed in the supine position following the references of the scanner's collection field. At the end of the scans, the body regions (body segments) were reviewed and only then was the body composition calculated.
2 secondary outcomes
Epworth Sleepiness Scale
Time frame: Pre-intervention, 6 and 12 weeks intervention
Insomnia Severity Index
Time frame: Pre-intervention, 6 and 12 weeks 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 2 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Vania D'Almeida, PhD study chair
Universidade Federal de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep and Resistance Exercise in people with Sarcopenia and Sleep, run by Federal University of São Paulo at 1 site in Brazil.
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 6 inclusion and 11 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 2 Mar 2020. 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 Brazil. 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?
Polysomnography (time frame: Pre-intervention end (12 weeks) intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2020.