Clinical trial NCT03616249: Exercise and the Sleep for the Sarcopenic Elderly
Official title: Resistance Training Improves Sleep Profile of Elderly Sarcopenic Patients: A Randomized Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Sleep
Physical Activity
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 28
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Polysomnography
timeFrame: Pre-intervention end (12 weeks) intervention
measure: Pitsburgh Sleep Quality Index
timeFrame: Pre-intervention, 6 and 12 weeks intervention
measure: Evaluation of Sleep-Wake Cycle - Actigraphy
timeFrame: Pre-intervention, 6 and 12 weeks intervention
measure: Biochemical Assessments
timeFrame: Pre-intervention, 6 and 12 weeks intervention
measure: Short Physical Performance Battery (SPPB) - Brazilian Version
timeFrame: Pre-intervention, 6 and 12 weeks interventionn
measure: Manual Grip Strength Assessment
timeFrame: Pre-intervention, 6 and 12 weeks intervention
measure: Body composition
timeFrame: Pre-intervention, 6 and 12 weeks intervention
Secondary outcomes:
measure: Epworth Sleepiness Scale
timeFrame: Pre-intervention, 6 and 12 weeks intervention
measure: Insomnia Severity Index
timeFrame: Pre-intervention, 6 and 12 weeks intervention
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: UNIFESP
state: São Paulo
Study officials:
affiliation: Universidade Federal de São Paulo
name: Vania D'Almeida, PhD
role: STUDY_CHAIR
References: