Exercise Mediation on Hormonal, Immune and Psychological Well-being in Institutionalized Frail Older Women. (UC)

June 15, 2020 updated by: Guilherme Eustáquio Furtado, University of Coimbra

Frailty syndrome is a complex aging expression determined by ontogenetic and phylogenetic factors. Chronic stress has been shown to have immunosuppressive effects, to accelerate immunosenescence and to cause cumulative disorders in many physiological systems, resulting in frail state. In a recent approach, Linda Fried and colleagues have developed a construct whose bases are muscle loss, negative energy balance and physical inactivity, called 'Frailty Cycle'. They identified five dimensions in the construct: weakness, low resistance to an effort, slowness, low physical activity, and weight loss, which were operationalized on five criteria to identify the Physical Frailty (PF), and divide the population in frail, pre-frail and non-frail. Recently, epidemiological studies reported that cognitive impairments, low immune expression, and others global health dimensions have a powerful association with physical frailty. However, there is a need for the search for new correlated markers for the frail condition, for a better understanding of the phenomenon. On the other hand, exercise has been shown as a co-adjuvant treatment to have positive effects on several factors linked to physical frailty (e.g. improve immunity and prevent chronic diseases), because of it's potential effect on hormonal mediation. Looking at Fried PF Phenotype construct, their dimensions share biological 'commonalities' that can be explained by studying the biopsychological mechanisms with exercise being a key factor in the study of these relationships.

The current research was designed to investigate and characterize the prevalence of the PF in a cross-sectional Portuguese samples (institutionalized participants), to examine the relationship between PF and each one of the general health status domain such as physical fitness and functioning status; neuroendocrine and immune parameters; psychological and cognitive ability of these populations; and to verified the impact of different types of exercise in each domain of general health status. However, this doctoral thesis is presented in the form of articles, divided into five sections and their respective chapters. In total, 3 preliminary studies (2 systematic reviews of studies 1 and 2 and one exercise-intervention pilot study 3), 5 cross-sectional studies (4,5,6,7, and 8) and 3 intervention studies (9,10 and 11) were completed. The cross-sectional design consisted of the assessment of 140 older women (≥75 years old), living in different centres of heath care and social support, located in the city of Coimbra, Portugal. The participants were selected using a non-probabilistic convenience sampling based on the geographical area of the center region of Coimbra city.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This research protocol was planned for approximately 13 months, involving a trained research team and it is built in different phases, according to the type of studies: cross- sectional and experimental. The cross-sectional study (4 weeks' duration) consisted in the evaluation of older people (65 years old), living in different centres of heath care and social support (HCS), located in the city of Coimbra, Portugal. The participants were selected using a non-probalistic convenience sampling based on the geographical area of center region of Coimbra city. The experimental phase characterized as an intervention study with two different chair-based exercise programs, designed to assess the effect of strength/elastic band and multimodal interventions on biopsychological outcomes in frail e pre- frail individuals. Participants in these groups was attended a 45 minutes' exercise session, two-three times per week during 28 weeks and were extracted using the Physical Frailty status from the cross-sectional study design.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Coimbra, Portugal, 3040-248
        • Care Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • inclusion criteria: a) ability to participate in a study with total duration of 12 months and encompassing three phases: cross-sectional study, intervention and detraining periods b) existence of an appropriate physical space to carry out the exercise sessions; c) required support of caregivers to assist with the elders' displacement to the exercise classes;

Exclusion Criteria:

  • The following selection criteria for participants included was adopted: a) take a part in this study spontaneously; b) drug therapy and clinical condition controlled and updated (it must be stable and enable participation in the exercise classes as decided by local medical staff); c) not completing the '8-foot-up and go test' in the maximum time of 50 seconds.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: EFFECTS OF A CHAIR-YOGA EXERCISES ON STRESS HORMONE LEVELS.
assess the changes mediated by exercise on activities of daily life and falls (autonomy), physical fitness, salivary cortisol and alpha amylase in older adults living in social care givers centers. Methods: 35 women (83.81 ± 6.6 years old) were divided into two groups: chair-yoga exercises (CY, n=20) and control group (CG, n=15). All subjects were evaluated before and after 14-weeks of intervention. CY was involved in classes two times per week, while the GC did not participate in any exercise.
Other: Physical exercise
Multi-modal exercise protocol
EXPERIMENTAL: Physical fralty and health outcomes of fitness, sex hormones.
The study aimed to investigate the association of frailty with diverse geriatric health characteristics and how the latter might contribute to the former. Cross-sectional data of 140 women aged over 75 years were analyzed. Fried's definition of physical frailty, psychological, sex hormones, disability and physical fitness outcomes were examined. Prevalence of frailty was 40%. Frail women had lower scores in cognitive and physical fitness, and high scores for depression and comorbidities. Significant correlations emerged between frailty and disability, fear of falling, aerobic resistance and cognition showed that only aerobic resistance and cognition. A trend towards lower systolic blood pressure in the frail group may reflect being less physically active and/or having more systemic comorbidity. Using simple functional fitness and cognitive measures rather than using less reliable self-report assessments can better identify those with physical frailty.
Other: Physical exercise
Multi-modal exercise protocol
EXPERIMENTAL: physical fitness and frailty syndrome institutionalized older

This study analyzed the relationship between old physical frailty syndrome (PF) and PhFi indicators and assessed how the latter might predict the former. Participants were 119 elderly women (81.96 ±7.89 years) recruited from four social and healthcare centers. PhFi was assessed through muscle strength tests of upper and lower limbs, endurance, agility-dynamic balance, flexibility and body composition.

The following PF indicators were assessed: weight loss, exhaustion, weakness, slowness and low physical activity level.
Other: Physical exercise
Multi-modal exercise protocol
EXPERIMENTAL: THE RELATIONSHIP BETWEEN FUNCTIONAL DISABILITY OUTCOMES
The associations between functional disability activities of life activities and frailty have already been explored. The contribution of each component of physical frailty and their contribution to understanding the early physical decline of older individuals are poorly explored. The relationships between PF and functional disability and to identify the independent components of frailty that most influence on disability in older women. A cross-sectional study of 119 (81,96±7,89) older women aged 75 and over. Functional disability was assessed through Agility-dynamic and Static balance tests, Activities of daily life and Falls risk screen outcomes.
Other: Physical exercise
Multi-modal exercise protocol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
physical exercise
Time Frame: 14 weeks
weight and height will be combined to report BMI in kg/m2
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Coimbra

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 5, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 5, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • University of Coimbra (CIDAF)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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