FrailtyNCT07118423
Effects of Resistance Training in Centenarians
A study testing Exercise in people with Frailty and Muscle Power, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
This study is a multicenter intervention evaluating the effectiveness and safety of resistance training in institutionalized centenarians. The aim of the study is to analyze the effects of 12 weeks of resistance training on frailty, muscle power, physical function, strength, functional independence, physical activity… Read more about this study
- Who is it for?
- Ages 100 years and older
- Conditions the study is for
- Frailty, Muscle Power, Old and Very Old People
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jan 2019to 31 Mar 2020
- 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 100 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Women and men aged 100 years and over living in geriatric nursing homes.
Who cannot join
- Participants were excluded if they were bedridden, going through an acute disease or presented any clinical condition contraindicating physical exercise as outlined in the American College of Sports Medicine's Guidelines.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a multicenter intervention evaluating the effectiveness and safety of resistance training in institutionalized centenarians.
The aim of the study is to analyze the effects of 12 weeks of resistance training on frailty, muscle power, physical function, strength, functional independence, physical activity, cardiovascular health, cognitive function, and quality of life in adults aged 100 and over living in nursing homes.
Read the detailed description
Although exercise interventions have shown benefits in octogenarians and nonagenarians, their potential for improving predictors of healthy ageing has not yet been explored in institutionalized centenarians
The aim of the study is to analyze the effects of 12 weeks of resistance training on frailty, muscle power, physical function, strength, functional independence, physical activity, cardiovascular health, cognitive function, and quality of life in adults aged 100 and over living in nursing homes.
- Being tested
- Exercise
- Medical subject headings
- Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
The intervention group performed twice per week, nonconsecutive, resistance training over 12 weeks. The sessions consisted of 1-3 sets of eight exercises at 50-70% of the estimated one-repetition maximum.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | The exercise group performed twice per week, nonconsecutive, resistance training over 12 weeks. Exercise sessions consisted of 1-3 sets of the 8-exercise routine at 50-70% of the estimated one-repetition maximum. Receives: Other: Exercise |
| Control group | No intervention | The control group received the usual care in nursing homes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty using Fried's Frailty Criteria
Fried's frailty phenotype is based on five criteria (habitual gait speed, handgrip strength , involuntary weight loss, exhaustion and low physical activity). The score ranges from 0 to 5, where each criterion met counts as one point. A score of 0 indicates best status, while a score of 5 indicates worst status.
Measured: T0 (baseline) and T1 (post 12 weeks)
Frailty using Frailty Trait Scale - Short Form
Frailty Trait Scale - Short Form evaluates 5 domains, including body mass index, physical activity, static balance, habitual gait speed and handgrip strength. The score ranges from 0 to 50, where each criterion met counts as one point. A score of 0 indicates best status, while a score of 50 indicates worst status.
Measured: T0 (baseline) and T1 (post 12 weeks)
Muscle power
Muscle power assessed in 30-s sit-to-stand test.
Measured: T0 (baseline) and T1 (post 12 weeks)
Physical function based on the Short Physical Performance Battery
The Short Physical Performance Battery is based on the ability to stand with the feet together in the side-by-side, semi-tandem, and tandem positions, time to walk 4 meters, and time to rise from a chair and return to the seated position 5 times. The score ranges from 0 to 12 points. Higher scores indicate better physical function, while lower scores reflect poorer physical function.
Measured: T0 (baseline) and T1 (post 12 weeks)
Physical function using Physical Performance Mobility Examination.
The Physical Performance Mobility Examination includes six mobility tasks integral to daily life: bed mobility, transfer skills, multiple stands from chair, standing balance, step-up, and ambulation. The score ranges from 0 to 12 points. Higher scores indicate better physical function, while lower scores reflect poorer physical function.
Measured: T0 (baseline) and T1 (post 12 weeks)
Physical function based on the gait speed in 6 meters.
Gait speed is measured in meters per second (m/s). Higher values indicate better mobility.
Measured: T0 (baseline) and T1 (post 12 weeks)
Physical function using the Time Up and Go test.
The Timed Up and Go test measures the time it takes participants to stand up, walk 3 meters, turn around, and sit back down. Shorter times reflect better mobility
Measured: T0 (baseline) and T1 (post 12 weeks)
Cognitive function using Mini Mental State Examination.
Mini Mental State Examination questionnaire incorporates 11 items that measure attention and orientation, memory, registration, recall, calculation, language, and ability to draw a complex polygon, and results in scores ranging from 1 (lowest cognitive function) to 30 (highest cognitive function) points.
Measured: T0 (baseline) and T1 (post 12 weeks)
Cognitive function using the animal naming test within 1 minute.
In the animal naming test, participants are asked to name as many animals as possible in 60 seconds. The higher number of correctly named reflects better cognitive function.
Measured: T0 (baseline) and T1 (post 12 weeks)
Cognitive function using the clock drawing test.
The score in the clock drawing test ranges from 0 to 10. This score evalutes visuospatial skills, executive functions, and the ability to follow instructions. Higher scores indicate better cognitive function.
Measured: T0 (baseline) and T1 (post 12 weeks)
Quality of life using EuroQoL-5 Dimension questionnaire.
EuroQoL-5D Index ranges from a value of 1 (best state of health) to 0 (death). Although there are negative values for the index, corresponding to those states of health that are valued as worse than death.
Measured: T0 (baseline) and T1 (post 12 weeks)
Quality of life using Visual Analog Scale.
Visual Analog Scale evaluates self-reported quality of life on a vertical scale ranging from 0 (worst health) to 100 (best health). This score provides a subjective measure of the patient's perception of their current health status.
Measured: T0 (baseline) and T1 (post 12 weeks)
Isometric muscle strength
Maximum voluntary isometric strength in handgrip, knee extension, elbow flexion and should abduction, measured using a dynamometer.
Measured: T0 (baseline) and T1 (post 12 weeks)
Disability
The Barthel index is a 10-item questionnaire that provides information about the autonomy to cook food, wash, dress, groom, perform bowel movements and urination, go to the toilet, move from the bed to the chair, walk and climb stair. The total score ranges from 0 to 100, with higher scores indicating greater independence (best), and lower scores indicating higher levels of dependence in basic daily activities.
Measured: T0 (baseline) and T1 (post 12 weeks)
Accelerometer-based physical activity
Measurement of physical activity levels (i.e., time spent in light-intensity and moderate-to-vigorous intensity) by accelerometer 24 hours a day for seven consecutive days using a GENEActiv device worn on the non-dominant wrist.
Measured: T0 (baseline) and T1 (post 12 weeks)
Falls
The number of falls in the last year was registered.
Measured: T0 (baseline) and T1 (post 12 weeks)
Heart rate variability indices from electrocardiogram (ECG)
Heart rate variability indices were derived from 10-minute resting recordings using a 12-lead Holter ECG. Both linear indices (time and frequency domains) and non-linear indices (detrended fluctuation ) were calculated from the ECG recording.
Measured: T0 (baseline) and T1 (post 12 weeks)
Blood pressure
Blood pressure is measured in millimeters of mercury (mmHg), including systolic, diastolic, and mean arterial pressure (calculated as diastolic pressure plus one-third of the difference between systolic and diastolic pressures).
Measured: T0 (baseline) and T1 (post 12 weeks)
Ankle-brachial index relate to blood pressure
The ankle-brachial index (ABI) is calculated by measuring systolic pressure in both ankles and both arms. The highest systolic pressure from the arms is used as a reference. The highest systolic pressure from each ankle is divided by this reference to obtain an ABI for each leg. The final ABI value is the lower of the two leg measurements.
Measured: T0 (baseline) and T1 (post 12 weeks)
Albumin
Albumin concentration is measured in blood samples.
Measured: T0 (baseline) and T1 (post 12 weeks)
C-reactive protein
C-reactive protein concentration is measured in blood samples.
Measured: T0 (baseline) and T1 (post 12 weeks)
inflammatory cytokines
Inflammatory cytokines (IL-6 and IL-1β) are measured in blood samples.
Measured: T0 (baseline) and T1 (post 12 weeks)
Circulating microRNA levels
MicroRNAs associated with frailty (miR-194-5p, miR-125b-5p) are measured in blood samples.
Measured: T0 (baseline) and T1 (post 12 weeks)
Gene expressions of aging (ABLIM1, CCR7, LEF1, EGR1)
Gene expressions of aging (ABLIM1, CCR7, LEF1, EGR1) are measured in blood samples.
Measured: T0 (baseline) and T1 (post 12 weeks)
Secondary outcomes (1)
Resilience
The Brief Resilience Scale consists of 6 items designed to measure the ability to recover or "bounce back" from stress. The average score ranges from 1 to 5, and higher values indicate better resilience.
Measured: Only baseline (T0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start8 Jan 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies 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
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Collaborators
- University of Castilla-La Mancha
- Responsible party
- Principal investigator, Adrián Hernández-Vicente, Universidad de Zaragoza
- Investigators
- Nuria Garatachea, PhD, Principal investigator, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118423
- Sponsor's protocol ID
- #PI18/381
- Status last verified
- Aug 2025
- First submitted
- 14 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistance Training in Centenarians
- ClinicalTrials.gov ID
- NCT07118423
- Acronym / sponsor ID
- #PI18/381
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Collaborators
- University of Castilla-La Mancha
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 12 Aug 2025 (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.
This study is a multicenter intervention evaluating the effectiveness and safety of resistance training in institutionalized centenarians.
The aim of the study is to analyze the effects of 12 weeks of resistance training on frailty, muscle power, physical function, strength, functional independence, physical activity, cardiovascular health, cognitive function, and quality of life in adults aged 100 and over living in nursing homes.
Detailed description
Although exercise interventions have shown benefits in octogenarians and nonagenarians, their potential for improving predictors of healthy ageing has not yet been explored in institutionalized centenarians
The aim of the study is to analyze the effects of 12 weeks of resistance training on frailty, muscle power, physical function, strength, functional independence, physical activity, cardiovascular health, cognitive function, and quality of life in adults aged 100 and over living in nursing homes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: ExerciseThe exercise group performed twice per week, nonconsecutive, resistance training over 12 weeks. Exercise sessions consisted of 1-3 sets of the 8-exercise routine at 50-70% of the estimated one-repetition maximum. |
| Control group | No intervention | –The control group received the usual care in nursing homes. |
Who may qualify
- Ages
- 100 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Women and men aged 100 years and over living in geriatric nursing homes.
Key exclusion criteria (1 listed)
- Participants were excluded if they were bedridden, going through an acute disease or presented any clinical condition contraindicating physical exercise as outlined in the American College of Sports Medicine's Guidelines.
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 |
|---|---|---|
| ExerciseThe intervention group performed twice per week, nonconsecutive, resistance training over 12 weeks. The sessions consisted of 1-3 sets of eight exercises at 50-70% of the estimated one-repetition maximum. | Other | Exercise group |
Primary outcome
Frailty using Fried's Frailty Criteria
Time frame: T0 (baseline) and T1 (post 12 weeks)
Fried's frailty phenotype is based on five criteria (habitual gait speed, handgrip strength , involuntary weight loss, exhaustion and low physical activity). The score ranges from 0 to 5, where each criterion met counts as one point. A score of 0 indicates best status, while a score of 5 indicates worst status.
Frailty using Frailty Trait Scale - Short Form
Time frame: T0 (baseline) and T1 (post 12 weeks)
Frailty Trait Scale - Short Form evaluates 5 domains, including body mass index, physical activity, static balance, habitual gait speed and handgrip strength. The score ranges from 0 to 50, where each criterion met counts as one point. A score of 0 indicates best status, while a score of 50 indicates worst status.
Muscle power
Time frame: T0 (baseline) and T1 (post 12 weeks)
Muscle power assessed in 30-s sit-to-stand test.
Physical function based on the Short Physical Performance Battery
Time frame: T0 (baseline) and T1 (post 12 weeks)
The Short Physical Performance Battery is based on the ability to stand with the feet together in the side-by-side, semi-tandem, and tandem positions, time to walk 4 meters, and time to rise from a chair and return to the seated position 5 times. The score ranges from 0 to 12 points. Higher scores indicate better physical function, while lower scores reflect poorer physical function.
Physical function using Physical Performance Mobility Examination.
Time frame: T0 (baseline) and T1 (post 12 weeks)
The Physical Performance Mobility Examination includes six mobility tasks integral to daily life: bed mobility, transfer skills, multiple stands from chair, standing balance, step-up, and ambulation. The score ranges from 0 to 12 points. Higher scores indicate better physical function, while lower scores reflect poorer physical function.
Physical function based on the gait speed in 6 meters.
Time frame: T0 (baseline) and T1 (post 12 weeks)
Gait speed is measured in meters per second (m/s). Higher values indicate better mobility.
Physical function using the Time Up and Go test.
Time frame: T0 (baseline) and T1 (post 12 weeks)
The Timed Up and Go test measures the time it takes participants to stand up, walk 3 meters, turn around, and sit back down. Shorter times reflect better mobility
Cognitive function using Mini Mental State Examination.
Time frame: T0 (baseline) and T1 (post 12 weeks)
Mini Mental State Examination questionnaire incorporates 11 items that measure attention and orientation, memory, registration, recall, calculation, language, and ability to draw a complex polygon, and results in scores ranging from 1 (lowest cognitive function) to 30 (highest cognitive function) points.
Cognitive function using the animal naming test within 1 minute.
Time frame: T0 (baseline) and T1 (post 12 weeks)
In the animal naming test, participants are asked to name as many animals as possible in 60 seconds. The higher number of correctly named reflects better cognitive function.
Cognitive function using the clock drawing test.
Time frame: T0 (baseline) and T1 (post 12 weeks)
The score in the clock drawing test ranges from 0 to 10. This score evalutes visuospatial skills, executive functions, and the ability to follow instructions. Higher scores indicate better cognitive function.
Quality of life using EuroQoL-5 Dimension questionnaire.
Time frame: T0 (baseline) and T1 (post 12 weeks)
EuroQoL-5D Index ranges from a value of 1 (best state of health) to 0 (death). Although there are negative values for the index, corresponding to those states of health that are valued as worse than death.
Quality of life using Visual Analog Scale.
Time frame: T0 (baseline) and T1 (post 12 weeks)
Visual Analog Scale evaluates self-reported quality of life on a vertical scale ranging from 0 (worst health) to 100 (best health). This score provides a subjective measure of the patient's perception of their current health status.
Isometric muscle strength
Time frame: T0 (baseline) and T1 (post 12 weeks)
Maximum voluntary isometric strength in handgrip, knee extension, elbow flexion and should abduction, measured using a dynamometer.
Disability
Time frame: T0 (baseline) and T1 (post 12 weeks)
The Barthel index is a 10-item questionnaire that provides information about the autonomy to cook food, wash, dress, groom, perform bowel movements and urination, go to the toilet, move from the bed to the chair, walk and climb stair. The total score ranges from 0 to 100, with higher scores indicating greater independence (best), and lower scores indicating higher levels of dependence in basic daily activities.
Accelerometer-based physical activity
Time frame: T0 (baseline) and T1 (post 12 weeks)
Measurement of physical activity levels (i.e., time spent in light-intensity and moderate-to-vigorous intensity) by accelerometer 24 hours a day for seven consecutive days using a GENEActiv device worn on the non-dominant wrist.
Falls
Time frame: T0 (baseline) and T1 (post 12 weeks)
The number of falls in the last year was registered.
Heart rate variability indices from electrocardiogram (ECG)
Time frame: T0 (baseline) and T1 (post 12 weeks)
Heart rate variability indices were derived from 10-minute resting recordings using a 12-lead Holter ECG. Both linear indices (time and frequency domains) and non-linear indices (detrended fluctuation ) were calculated from the ECG recording.
Blood pressure
Time frame: T0 (baseline) and T1 (post 12 weeks)
Blood pressure is measured in millimeters of mercury (mmHg), including systolic, diastolic, and mean arterial pressure (calculated as diastolic pressure plus one-third of the difference between systolic and diastolic pressures).
Ankle-brachial index relate to blood pressure
Time frame: T0 (baseline) and T1 (post 12 weeks)
The ankle-brachial index (ABI) is calculated by measuring systolic pressure in both ankles and both arms. The highest systolic pressure from the arms is used as a reference. The highest systolic pressure from each ankle is divided by this reference to obtain an ABI for each leg. The final ABI value is the lower of the two leg measurements.
Albumin
Time frame: T0 (baseline) and T1 (post 12 weeks)
Albumin concentration is measured in blood samples.
C-reactive protein
Time frame: T0 (baseline) and T1 (post 12 weeks)
C-reactive protein concentration is measured in blood samples.
inflammatory cytokines
Time frame: T0 (baseline) and T1 (post 12 weeks)
Inflammatory cytokines (IL-6 and IL-1β) are measured in blood samples.
Circulating microRNA levels
Time frame: T0 (baseline) and T1 (post 12 weeks)
MicroRNAs associated with frailty (miR-194-5p, miR-125b-5p) are measured in blood samples.
Gene expressions of aging (ABLIM1, CCR7, LEF1, EGR1)
Time frame: T0 (baseline) and T1 (post 12 weeks)
Gene expressions of aging (ABLIM1, CCR7, LEF1, EGR1) are measured in blood samples.
1 secondary outcome
Resilience
Time frame: Only baseline (T0)
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 12 Aug 2025.
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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.
Nuria Garatachea, PhD principal investigator
Universidad de Zaragoza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Frailty and Muscle Power, run by Universidad de Zaragoza at 1 site in Spain.
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 12 Aug 2025. 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 Spain. 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?
Frailty using Fried's Frailty Criteria (time frame: T0 (baseline) and T1 (post 12 weeks)). The study lists 24 primary outcomes in all. 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 12 Aug 2025.