Frail Elderly SyndromeUCNCT04435899
Exercise Mediation on Hormonal, Immune and Psychological Well-being in Institutionalized Frail Older Women.
A study testing Physical exercise in people with Frail Elderly Syndrome, run by University of Coimbra at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frail Elderly Syndrome
- What is being tested?
- Physical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 sitePortugal
- Study dates
- 5 Jan 2018to 5 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Frail Elderly Syndrome
- Being tested
- Physical exercise
- Keywords
- Frail-older adults, disability, physical fitness, sex steroid hormones, cognition, motor skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseOther
Multi-modal exercise protocol
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical exercise
weight and height will be combined to report BMI in kg/m2
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start5 Jan 2018
- Primary completion5 Mar 2018
- Study completion5 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guilherme Eustáquio Furtado, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435899
- Sponsor's protocol ID
- University of Coimbra (CIDAF)
- Acronym
- UC
- Status last verified
- Jun 2020
- First submitted
- 3 Jun 2020
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Mediation on Hormonal, Immune and Psychological Well-being in Institutionalized Frail Older Women.
- ClinicalTrials.gov ID
- NCT04435899
- Acronym / sponsor ID
- UC / University of Coimbra (CIDAF)
- Conditions
- Frail Elderly Syndrome
- Keywords
- Frail-older adults, disability, physical fitness, sex steroid hormones, cognition, motor skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 5 Mar 2018 (actual)
- Study completion
- 5 Jul 2018 (actual)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| EFFECTS OF A CHAIR-YOGA EXERCISES ON STRESS HORMONE LEVELS. | Experimental | Other: Physical exerciseassess 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. |
| Physical fralty and health outcomes of fitness, sex hormones. | Experimental | Other: Physical exerciseThe 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. |
| physical fitness and frailty syndrome institutionalized older | Experimental | Other: Physical exerciseThis 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. |
| THE RELATIONSHIP BETWEEN FUNCTIONAL DISABILITY OUTCOMES | Experimental | Other: Physical exerciseThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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;
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical exerciseMulti-modal exercise protocol | Other | EFFECTS OF A CHAIR-YOGA EXERCISES ON STRESS HORMONE LEVELS., Physical fralty and health outcomes of fitness, sex hormones., THE RELATIONSHIP BETWEEN FUNCTIONAL DISABILITY OUTCOMES, physical fitness and frailty syndrome institutionalized older |
Primary outcome
physical exercise
Time frame: 14 weeks
weight and height will be combined to report BMI in kg/m2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise in people with Frail Elderly Syndrome, run by University of Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physical exercise (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020; AzTrials last refreshed its copy on 7 Nov 2026.