- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04435899
Exercise Mediation on Hormonal, Immune and Psychological Well-being in Institutionalized Frail Older Women. (UC)
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Coimbra, Portugal, 3040-248
- Care Centers
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
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. |
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.
|
Multi-modal exercise protocol
|
What is the study measuring?
Primary Outcome Measures
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
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- University of Coimbra (CIDAF)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Frail Elderly Syndrome
-
DSM Nutritional Products, Inc.CompletedFrail Elderly | Pre-frail ElderlyNetherlands
-
McMaster UniversityAlberta Health services; Saskatchewan Health Authority - Regina Area; Canadian... and other collaboratorsActive, not recruitingFrail Elderly SyndromeCanada
-
Università degli Studi del Piemonte Orientale "Amedeo...Completed
-
University of Massachusetts, WorcesterAnesthesia Patient Safety FoundationCompleted
-
School of Health Sciences GenevaInstitution genevoise de maintien à domicileCompletedFrail Elderly Syndrome
-
University of GlasgowNHS Greater Glasgow and ClydeUnknownFrail Elderly SyndromeUnited Kingdom
-
Castilla-La Mancha Health ServiceColegio Oficial de Terapeutas Ocupacionales de Castilla - La Mancha; Fundación... and other collaboratorsRecruiting
-
Federico II UniversityRecruiting
-
Guang Yang, Prof. Dr.CompletedFrail Elderly SyndromeChina
Clinical Trials on Physical exercise
-
Region StockholmKarolinska InstitutetRecruitingBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar II Disorder | Bipolar Affective Disorder; Remission in | Bipolar Affective Disorder, Currently Depressed, ModerateSweden
-
Universidade Estadual da ParaibaUniversity of Campinas, BrazilUnknown
-
Instituto de Cardiologia do Rio Grande do SulFundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, BrazilTerminatedObesity | Sedentary Lifestyle | Hypercholesterolemia | High Blood PressureBrazil
-
Clarice Maria de Lucena MartinsCompletedMetabolic Diseases | Physical Activity
-
McGill UniversityUniversité du Québec à Trois-Rivières; Université de Montréal; Concordia University... and other collaboratorsRecruiting
-
National Research Centre for the Working Environment...CompletedMusculoskeletal DisordersDenmark
-
Cardiff UniversityCompletedParkinson's DiseaseUnited Kingdom
-
Instituto Materno Infantil Prof. Fernando FigueiraCompleted
-
Universidad Católica San Antonio de MurciaCompleted
-
Göteborg UniversityVastra Gotaland Region; Sahlgrenska University Hospital, SwedenCompletedChronic Widespread PainSweden