<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04435899</url>
  </required_header>
  <id_info>
    <org_study_id>University of Coimbra (CIDAF)</org_study_id>
    <nct_id>NCT04435899</nct_id>
  </id_info>
  <brief_title>Exercise Mediation on Hormonal, Immune and Psychological Well-being in Institutionalized Frail Older Women.</brief_title>
  <acronym>UC</acronym>
  <official_title>Exercise Mediation on Hormonal, Immune and Psychological Well-being in Institutionalized Frail Older Women.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Coimbra</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Coimbra</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Frailty syndrome is a complex aging expression determined by ontogenetic and phylogenetic&#xD;
      factors. Chronic stress has been shown to have immunosuppressive effects, to accelerate&#xD;
      immunosenescence and to cause cumulative disorders in many physiological systems, resulting&#xD;
      in frail state. In a recent approach, Linda Fried and colleagues have developed a construct&#xD;
      whose bases are muscle loss, negative energy balance and physical inactivity, called 'Frailty&#xD;
      Cycle'. They identified five dimensions in the construct: weakness, low resistance to an&#xD;
      effort, slowness, low physical activity, and weight loss, which were operationalized on five&#xD;
      criteria to identify the Physical Frailty (PF), and divide the population in frail, pre-frail&#xD;
      and non-frail. Recently, epidemiological studies reported that cognitive impairments, low&#xD;
      immune expression, and others global health dimensions have a powerful association with&#xD;
      physical frailty. However, there is a need for the search for new correlated markers for the&#xD;
      frail condition, for a better understanding of the phenomenon. On the other hand, exercise&#xD;
      has been shown as a co-adjuvant treatment to have positive effects on several factors linked&#xD;
      to physical frailty (e.g. improve immunity and prevent chronic diseases), because of it's&#xD;
      potential effect on hormonal mediation. Looking at Fried PF Phenotype construct, their&#xD;
      dimensions share biological 'commonalities' that can be explained by studying the&#xD;
      biopsychological mechanisms with exercise being a key factor in the study of these&#xD;
      relationships.&#xD;
&#xD;
      The current research was designed to investigate and characterize the prevalence of the PF in&#xD;
      a cross-sectional Portuguese samples (institutionalized participants), to examine the&#xD;
      relationship between PF and each one of the general health status domain such as physical&#xD;
      fitness and functioning status; neuroendocrine and immune parameters; psychological and&#xD;
      cognitive ability of these populations; and to verified the impact of different types of&#xD;
      exercise in each domain of general health status. However, this doctoral thesis is presented&#xD;
      in the form of articles, divided into five sections and their respective chapters. In total,&#xD;
      3 preliminary studies (2 systematic reviews of studies 1 and 2 and one exercise-intervention&#xD;
      pilot study 3), 5 cross-sectional studies (4,5,6,7, and 8) and 3 intervention studies (9,10&#xD;
      and 11) were completed. The cross-sectional design consisted of the assessment of 140 older&#xD;
      women (≥75 years old), living in different centres of heath care and social support, located&#xD;
      in the city of Coimbra, Portugal. The participants were selected using a non-probabilistic&#xD;
      convenience sampling based on the geographical area of the center region of Coimbra city.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research protocol was planned for approximately 13 months, involving a trained research&#xD;
      team and it is built in different phases, according to the type of studies: cross- sectional&#xD;
      and experimental. The cross-sectional study (4 weeks' duration) consisted in the evaluation&#xD;
      of older people (65 years old), living in different centres of heath care and social support&#xD;
      (HCS), located in the city of Coimbra, Portugal. The participants were selected using a&#xD;
      non-probalistic convenience sampling based on the geographical area of center region of&#xD;
      Coimbra city. The experimental phase characterized as an intervention study with two&#xD;
      different chair-based exercise programs, designed to assess the effect of strength/elastic&#xD;
      band and multimodal interventions on biopsychological outcomes in frail e pre- frail&#xD;
      individuals. Participants in these groups was attended a 45 minutes' exercise session,&#xD;
      two-three times per week during 28 weeks and were extracted using the Physical Frailty status&#xD;
      from the cross-sectional study design.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 5, 2018</start_date>
  <completion_date type="Actual">July 5, 2018</completion_date>
  <primary_completion_date type="Actual">March 5, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>physical exercise</measure>
    <time_frame>14 weeks</time_frame>
    <description>weight and height will be combined to report BMI in kg/m2</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Frail Elderly Syndrome</condition>
  <arm_group>
    <arm_group_label>EFFECTS OF A CHAIR-YOGA EXERCISES ON STRESS HORMONE LEVELS.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physical fralty and health outcomes of fitness, sex hormones.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>physical fitness and frailty syndrome institutionalized older</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.&#xD;
The following PF indicators were assessed: weight loss, exhaustion, weakness, slowness and low physical activity level.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>THE RELATIONSHIP BETWEEN FUNCTIONAL DISABILITY OUTCOMES</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical exercise</intervention_name>
    <description>Multi-modal exercise protocol</description>
    <arm_group_label>EFFECTS OF A CHAIR-YOGA EXERCISES ON STRESS HORMONE LEVELS.</arm_group_label>
    <arm_group_label>Physical fralty and health outcomes of fitness, sex hormones.</arm_group_label>
    <arm_group_label>THE RELATIONSHIP BETWEEN FUNCTIONAL DISABILITY OUTCOMES</arm_group_label>
    <arm_group_label>physical fitness and frailty syndrome institutionalized older</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  inclusion criteria: a) ability to participate in a study with total duration of 12&#xD;
             months and encompassing three phases: cross-sectional study, intervention and&#xD;
             detraining periods b) existence of an appropriate physical space to carry out the&#xD;
             exercise sessions; c) required support of caregivers to assist with the elders'&#xD;
             displacement to the exercise classes;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The following selection criteria for participants included was adopted: a) take a part&#xD;
             in this study spontaneously; b) drug therapy and clinical condition controlled and&#xD;
             updated (it must be stable and enable participation in the exercise classes as decided&#xD;
             by local medical staff); c) not completing the '8-foot-up and go test' in the maximum&#xD;
             time of 50 seconds.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Care Centers</name>
      <address>
        <city>Coimbra</city>
        <zip>3040-248</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Coimbra</investigator_affiliation>
    <investigator_full_name>Guilherme Eustáquio Furtado</investigator_full_name>
    <investigator_title>Researcher, principal investigator</investigator_title>
  </responsible_party>
  <keyword>Frail-older adults</keyword>
  <keyword>disability</keyword>
  <keyword>physical fitness</keyword>
  <keyword>sex steroid hormones</keyword>
  <keyword>cognition</keyword>
  <keyword>motor skills</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04435899
org study id: University of Coimbra (CIDAF)
nct id: NCT04435899
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: physical exercise
time frame: 14 weeks
description: weight and height will be combined to report BMI in kg/m2
arm group label: EFFECTS OF A CHAIR-YOGA EXERCISES ON STRESS HORMONE LEVELS.
arm group type: Experimental
description: 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.
arm group label: Physical fralty and health outcomes of fitness, sex hormones.
arm group type: Experimental
description: 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.
arm group label: physical fitness and frailty syndrome institutionalized older
arm group type: Experimental
description: 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.
arm group label: THE RELATIONSHIP BETWEEN FUNCTIONAL DISABILITY OUTCOMES
arm group type: Experimental
description: 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.
intervention type: Other
intervention name: Physical exercise
description: Multi-modal exercise protocol
arm group label: EFFECTS OF A CHAIR-YOGA EXERCISES ON STRESS HORMONE LEVELS.
arm group label: Physical fralty and health outcomes of fitness, sex hormones.
arm group label: THE RELATIONSHIP BETWEEN FUNCTIONAL DISABILITY OUTCOMES
arm group label: physical fitness and frailty syndrome institutionalized older
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Portugal
responsible party type: Principal Investigator
investigator affiliation: University of Coimbra
investigator full name: Guilherme Eustáquio Furtado
investigator title: Researcher, principal investigator
sharing ipd: Undecided