NCT04435899

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 17, 2020

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

2 months

First QC Date

June 3, 2020

Last Update Submit

June 15, 2020

Conditions

Keywords

Frail-older adultsdisabilityphysical fitnesssex steroid hormonescognitionmotor skills

Outcome Measures

Primary Outcomes (1)

  • physical exercise

    weight and height will be combined to report BMI in kg/m2

    14 weeks

Study Arms (4)

EFFECTS OF A CHAIR-YOGA EXERCISES ON STRESS HORMONE LEVELS.

EXPERIMENTAL

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

Physical fralty and health outcomes of fitness, sex hormones.

EXPERIMENTAL

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

physical fitness and frailty syndrome institutionalized older

EXPERIMENTAL

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

THE RELATIONSHIP BETWEEN FUNCTIONAL DISABILITY OUTCOMES

EXPERIMENTAL

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

Interventions

Multi-modal exercise protocol

EFFECTS OF A CHAIR-YOGA EXERCISES ON STRESS HORMONE LEVELS.Physical fralty and health outcomes of fitness, sex hormones.THE RELATIONSHIP BETWEEN FUNCTIONAL DISABILITY OUTCOMESphysical fitness and frailty syndrome institutionalized older

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Care Centers

Coimbra, 3040-248, Portugal

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher, principal investigator

Study Record Dates

First Submitted

June 3, 2020

First Posted

June 17, 2020

Study Start

January 5, 2018

Primary Completion

March 5, 2018

Study Completion

July 5, 2018

Last Updated

June 17, 2020

Record last verified: 2020-06

Locations