Exercise and the Sleep for the Sarcopenic Elderly

Physical Activity Clinical Trial

— ESSE  

Official title:

Resistance Training Improves Sleep Profile of Elderly Sarcopenic Patients: A Randomized Trail

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03616249
• Other study ID #: 1388065
• Status: Completed
• Phase: N/A
• Start date: March 3, 2017
• Est. completion date: December 10, 2019

Study information

• Verified date: February 2020
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 10, 2019
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

Have controlled

• blood glucose,

• blood pressure

• osteoporosis

• ability to understand and perform the physical performance test batteries

• ability to training protocol safely.

Exclusion Criteria:

• 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,

• Chronic obstructive pulmonary disease,

• Intermittent claudication,

• Psychiatric disorder,

• Incapacitates in understanding and performing tests and,

• Incapacitate to performing physical training safely.

Related Conditions & MeSH terms

• Physical Activity
• Sarcopenia
• Sleep

Intervention

Other:
• Sleep
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 Exercise
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.

Locations

Country	Name	City	State
Brazil	UNIFESP	Sao Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre-intervention end (12 weeks) intervention
Primary	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.	Pre-intervention, 6 and 12 weeks intervention
Primary	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.	Pre-intervention, 6 and 12 weeks intervention
Primary	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-a), interleukin-1 receptor antagonist (IL-1ra), interleukin (IL)-6 and IL-10 by the immunoenzymatic assay method (RayBio® ELISA Kits).	Pre-intervention, 6 and 12 weeks intervention
Primary	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.	Pre-intervention, 6 and 12 weeks interventionn
Primary	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)	Pre-intervention, 6 and 12 weeks intervention
Primary	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.	Pre-intervention, 6 and 12 weeks intervention
Secondary	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.	Pre-intervention, 6 and 12 weeks intervention
Secondary	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	Pre-intervention, 6 and 12 weeks intervention