Exercise and the Sleep for the Sarcopenic Elderly

NCT03616249 | Completed DMC

• 1 other identifier: 1388065
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcopenia; Sleep; Physical Activity

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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).

  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.

  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)

  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.

  Pre-intervention, 6 and 12 weeks intervention

Secondary Outcomes (2)

• Epworth Sleepiness Scale

  Pre-intervention, 6 and 12 weeks intervention

• Insomnia Severity Index

  Pre-intervention, 6 and 12 weeks intervention

Study Arms (4)

Sleep quality

EXPERIMENTAL

To compare if elderly sartcopics present sleep losses at higher levels than non-sarcopenic elderly

Other: Sleep

sleep-wake cycle.

EXPERIMENTAL

To compare if elderly sarcopenics present sleep-wake cycle. disorders at higher levels than non-sarcopenic elderly

Other: Sleep

Exercise And Sleep quality

ACTIVE COMPARATOR

Comparing resistance training in the sarcopenician elderly showed improvements in sleep patterns.

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.

Other: Sleep; Other: Resistance Exercise

Interventions

Sleep OTHER

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.

Exercise And Sleep quality; Exercise And sleep-wake cycle.; Sleep quality; sleep-wake cycle.

Resistance Exercise OTHER

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.

Exercise And Sleep quality; Exercise And sleep-wake cycle.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Have controlled
• blood glucose,
• blood pressure
• osteoporosis
• ability to understand and perform the physical performance test batteries
• ability to training protocol safely.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

UNIFESP

São Paulo, São Paulo, 04024-002, Brazil

Location

MeSH Terms

Conditions

Sarcopenia; Motor Activity

Interventions

Sleep; Resistance Training

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena

Study Officials

• Vania D'Almeida, PhD

  Universidade Federal de São Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: August 6, 2018
• Study Start: March 3, 2017
• Primary Completion: October 10, 2018
• Study Completion: December 10, 2019
• Last Updated: March 2, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)