Frail Elderly SyndromeEXERNETElderNCT03831841
Physical Fitness, Body Composition and Frailty in Elderly People.Exercise Program Effecsts. EXERNET Elder 3.0
A study testing Multicomponent exercise programe in people with Frail Elderly Syndrome and Sarcopenia, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
One of the major changes occurring in developed societies is a significant ageing of the population. Nowadays, because of an enhanced life expectancy, 17% of the Spanish population is composed of people over 65 and the number is expected to rise to 33% in 2050. 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, Sarcopenia, Physical Activity
- What is being tested?
- Multicomponent exercise programe
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- 5 Nov 2018to 4 Dec 2019
- 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
- Above 65 years
- frailty of pre-frailty by SPPB.
Who cannot join
- Severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Fitness Body Composition and Frailty in Elderly People Above 65 Years. Mediation of Vitamin D and Exercise Program Effects. EXERNET Elder 3.0
One of the major changes occurring in developed societies is a significant ageing of the population. Nowadays, because of an enhanced life expectancy, 17% of the Spanish population is composed of people over 65 and the number is expected to rise to 33% in 2050. Aging is characterized by a gradual lifelong accumulation of molecular and cellular damage that results in a progressive and generalized impairment in several bodily functions, an increased vulnerability to environmental challenges and a growing risk of disease and risk of death. These facts led to an increase on the prevalence of diseases such as osteoporosis diabetes, sarcopenia, obesity or frailty. However, lifestyles such as physical activity could attenuated aging process, maintaining the autonomy of elders, and it has been demonstrated that even implying guided exercise programs could reverse this condition of frailty and dependence.
In this way, the main aims of this research project are to analyze the effect of a multicomponent exercise program in frailty and pre-frailty people above 65 years and without cognitive impairment. Thus, it is going to be evaluated at the beginning and the end of the study; body composition, physical fitness, blood parameters including vitamin D and other health related parameters included in a questionnaire. Secondly, to study the perdurability of training-related gains over time.
Read the detailed description
The training will consist in a multicomponent exercise program, 3 days a week (Monday, Wednesday and Friday). It will take place during morning in groups of 10-14 and trainers will be qualified. Alll the exercise will be adapted for different levels of frailty and for their functional capacity.
- Conditions
- Frail Elderly Syndrome, Sarcopenia, Physical Activity
- Being tested
- Multicomponent exercise programe
- Keywords
- elderly, multicomponent exercise, body composition, vitamin D, fitness
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent exercise programeBehavioural
An intervention consisting of training by a multicomponent program 3 times a week, working on aerobic capacity, flexibility, balance and strength.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Multicomponent exercise programe involving all physical fitness paramenters and consisting on sesions of 1 hour, 3 days a week. Receives: Behavioral: Multicomponent exercise programe |
| Control | No intervention | Control group with no intervention programe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SPPB
Short Physical Performance Battery by Romberg (SPPB): consist of walking 4m, a balance test with three levels (tandem, semi-tandem and stand up on one foot) and sit up and reach 5 times as fast as possible. Each test could point from 0 to 4, reaching a maximum of 12 months in the battery. Puntuation correspond to; 0-4 points the person is not valid, from 4 to 6 frails and form 7-9 pre-frailt
Measured: Change from Baseline at 3 months, 6 months and 12 months
Change in Senior fitness test physical performance battery
A fitness test battery in order to measured physical performance of elderly, it includes: flamingos test (for balance), 30m of walking speed, 30 seconds of sit and reach (strength of lower extremities), 30sconds of arm curl, 6 minutes test (aerobic capacity), sit-up and go test (agility), flexibility of upper and lower extremities. Results are registered without puntuation.
Measured: Change from Baseline at 3 months, 6 months and 12 months
Change of 25-OH Vitamin D concentrations
25-OH Vitamin D concentration in blood test
Measured: Change from Baseline at 3 months, 6 months and 12 months
Secondary outcomes (47)
Changes on Fried Scale
Fried frailty phenotype criteria; measured by 3 questiones (exhaustion, walking more than 2 or 2,5 jours a week (for men or women)a and to have lose weigth (4,5kg) in the last year), Handgrip and 4,5 meters walking. Those who point 2 or 3 are prefrail and 3 or more frail.
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on Leucocites
Measured by blood test (%)
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on Linfocites
Measured by blood test (%)
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on hemoglobine
Measured by blood test (%)
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on platelets
Measured by blood test (10^3/uL)
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on calcium
Measured by blood test (mg/dL)
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on Cholesterol
Measured by blood test (mg/dL)
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on HDL-Cholesterol
Measured by blood test (mg/dL)
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on LDL-Cholesterol
Measured by blood test (mg/dL)
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on Trigicerids
Measured by blood test (mg/dL)
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on uric acid
Measured by blood test (mg/dL)
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on urea
Measured by blood test (mg/dL)
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on creatine
Measured by blood test (mg/dL)
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on creatine kinasa
Measured by blood test (U/dL)
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on glucose
Measured by blood test (mg/dL)
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on lactate deydrogenase
Measured by blood test (UI/dL)
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on potasium
Measured by blood test (mEq/dL)
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on magnesium
Measured by blood test (mg/dL)
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on transferrine
Measured by blood test (mg/dL)
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on albumin
Measured by blood test (g/dL)
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on protein c reative
Measured by blood test (mg/dL)
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on Bone mass and structure by perifereal quantitative computed tomography
Mass and structure of tibia (at 4, 38, 66 % slides) and radius (4, 66 % slides) by pQCT
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on hip perimeter
Hip perimeter measured following ISAK protocol. Centimeters
Measured: Change from Baseline at 3 months, 6 months and 12 months
Change on wrist perimeter
Wrist perimeter following ISAK protocol. Centimeters
Measured: Change from Baseline at 3 months, 6 months and 12 months
Change on calf perimeter
Calf perimeter following ISAK protocol. Centimeters
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on arm relaxed perimeter
Calf perimeter following ISAK protocol. Centimeters
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on weight
Change on kilograms by bioimpedance measurement (TANITA)
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on body fat
Change on kilograms by bioimpedance measurement (TANITA)
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on efat percentage
Change on % by bioimpedance measurement (TANITA)
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on height
Change on height (cm)
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on Unkle-Brachial Index
Vascular measure to observed blood circultaion. With a Doppler, sistolic blood pressure measured in brachial arteries (humerus) and unkle arteries are measured. Then, ratio is calculated dividing both results.
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on FRAIL Scale
5 questions scale asking about; lose a 5% of own weigth in the last year, to have more than 5 diseases between cancer, diabetes, chloresterol, asthma, EPOC, IAM, cardiac insuficiency, arthritis, ACVA, ERC, angina, hipertension), exhaustion in the last 4 weeks ,ability to walk 10 steps without help, ability to walk more than 100 meters without help. Confirm 3 or more items means to be frail.
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on Clinical frailty scale
A descriptive scale about disability and funcional assessments. Is a practical and efficient tool for assessing frailty. It is compound of 9 options describing stages functionality depending on how much help they need for daily activities (1- very fit, 2- well, 3- managing well, 4- vulnerable, 5- mildly frail, 6- moderately frail, 7- severely frail, 8-very severely frail, 9- terminally ill). One option have to be selected.
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on Sociotype Questionnaire for geriatric population
Questionnaire about how people stablish their relationships between three social dimensions (family, friendship, and acquaintance). The questionnaire consisted of 12 questions which point from 0 to 5, having the high punctuation a positive meaning. Final mark is obtained from de sum up pf every point of each question.
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on Physical Activity Questionnnaire for the Elder (PASE)
Physical activity questionnaire to assesed daily light, moderate and vigorous physical activities. Physical Activity Scale for the Elderly (PASE) is a brief (5 minutes) and easily scored survey designed specifically to assess physical activity in persons age 65 years and older. The PASE score combines information on leisure, household and occupational activity. The PASE assesses the types of activities typically chosen by older adults (walking, recreational activities, exercise, housework, yard work, and caring for others. A total of 10 questions using frequency, duration, and intensity level of activity over the previous week to assign a score, ranging from 0 to 793, with higher scores indicating greater physical activity. Contribution of each questionnaire item to the overall PASE score is determined by the product of the sample mean and activity weight
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on Insomnia Severity Index Score
The Insomnia Severity Index (ISI) is a short instrument developed to assess insomnia severity Seven questions asking severity of difficulties to falling asleep, staying asleep, waking up too much early, how unsatisfied the person is with his sleep, how affect daily if there is a problem of sleep life. Severity must be pointed from 0 to 4 and the sum up of all question is calculated for the final mark. 0-7 lack of insomnia, 8-14 subclinical insomnia, 15-21 clinical insomnia (mild), 22-28 clinical insomnia (grave)
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on Incontinence Urinary Questionnaire
Questionnaire about urinary incontinence, how it affects they daily life pointing from 1 to 10 (being 10 too much worry) and when it happens. This question does not point, they are only registered.
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on EUROQOL (EQ-5D)
EQ-5D is a standardised measure of health status developed in order to provide a simple, generic measure of health for clinical and economic appraisal. It descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions. The second part of the questionnire records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents. It should be noted that the numerals 1-3 have no arithmetic properties and should not be used as a cardinal score.
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on Use of hospital Resources
Descriptive measure. Registration through the hospital internet private platform of; medication of the patient, number of medical appointments, number of specialised complementary tests, and other medical resourse that could be used by the patient related to healthcare system.
Measured: Change from Baseline, 6 months and 12 months
Change Lawton and Brody Index
Questionnaire about instrumental activities of daily life; Ability to Use Telephone Shopping, Laundry, Mode of Transportation, Food Preparation, Responsibility for Own Medications, Housekeeping and Ability to Handle Finances. Each part has 4 options to tick in order of independent to more dependent. Highest mark is 8 and correspond to a summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias.
Measured: Change from Baseline at 3 months, 6 months and 12 months
Changes on Barthel Index
Questionnaire about authonomy and dependence in; Feeding, Bathing , Grooming , Dressing , Bowel control , Bladder control , Toilet use , Transfers (bed to chair and back) (, Mobility on level surfaces , Stairs. Puntuation correspond to Independent +10points, Needs help+5points, Unable 0 points). Maximal puntuation is 100.which means independence.
Measured: Change from Baseline at 3 months, 6 months and 12 months.
Change on Risk of falls and Fear to Fall Assesment
Questionnaire about, have fear to fall, since when, give up activities because of fear and since when. No puntuation.
Measured: Change from Baseline at 3 months, 6 months and 12 months.
Change Sun Expousure Questionnaire
Questionnaire about hours expended outside, sun exposure and skin type. Only registration of data, without puntuations.
Measured: Change from Baseline at 3 months, 6 months and 12 months.
Change on Mediterranean Adherence Questionnaire PREDIMED
14 items questionnaire about adherence to Mediterranean diet patron each question is puntuated with 1 (positive to mediterrranean diet) or 0. The total puntuation is a sum up from the 14 questions. Questions are about olive oil , vegetable and fruit , meat, desserts, wine, fish, and legumes consumption.
Measured: Change from Baseline at 3 months, 6 months and 12 months.
Changes on Mini Nutritional Assesment
The MNA is a screening tool composed of two parts, 6 and 12 questions.First part permits detection of a decline in ingestion over the past three months (loss of appetite, decline of food intake, digestive problems, chewing or swallowing difficulties), weight loss in the past three months, current mobility impairment, an acute illness or major stress in the past three months, a neuropsychological problem (dementia or depression) and a decrease in body mass index (BMI). Second part of MNA evaluates living arrangements, the presence of polypharmacy or pressure ulcers, the number of full meals eaten daily, the amount and frequency of specific foods and fluids, and the mode of feeding. The patient reports nutritional and health status, and the practitioner determines weight and height (to calculate BMI), and mid-arm and mid-calf circumferences. The maximum score for first part is 14; a score of 12 points or greater means disorders.
Measured: Change from Baseline at 3 months, 6 months and 12 months.
Changes on ExernetElder questionnaire
Questionnaire about sociodemographic aspects such as participation on sports during lifespan, menarchy age and menopause age.
Descriptive registration.
Measured: Change from Baseline at 6 months and 12 months.
Change on Food Frequency Questionnaire
Food intake questionnaire (PREDIMED) asking about frequence of eating each food in last month. 139 different food from groups as daily products, eggs, meats and fishes, vegetables, fruits, legumes, fats and oils, desserts, miscalaneas and drinks. Each food could be answer with never, 1-3 a month, 1 a week, 2-4 a week, 5-6 a week, 1 a day, 2-3 a day, 4-6 a day, +6 a day.
Each pint is registered but they do not pointed.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start5 Nov 2018
- Primary completion30 Jun 2019
- Study completion4 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, German Vicente-Rodríguez, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831841
- Sponsor's protocol ID
- EXERNET Elder 3.0
- Acronym
- EXERNETElder
- Status last verified
- Jun 2020
- First submitted
- 2 Dec 2018
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Subias-Perie J, Navarrete-Villanueva D, Fernandez-Garcia AI, Moradell A, Alcala-Nalvaiz JT, Groessl EJ, Ara I, Vila-Maldonado S, Perez-Gomez J, Gonzalez-Gross M, Gomez-Cabello A, Vicente-Rodriguez G, Casajus JA. Cost-effectiveness of a multicomponent training programme for older adults with decreased functional capacity: An economic evaluation. Exp Gerontol. 2025 Nov;211:112911. doi: 10.1016/j.exger.2025.112911. Epub 2025 Sep 25.
PubMed 41015204Moradell A, Iguacel I, Navarrete-Villanueva D, Fernandez-Garcia AI, Gonzalez-Gross M, Perez-Gomez J, Ara I, Casajus JA, Gomez-Cabello A, Vicente-Rodriguez G. Effects of a multicomponent training and a detraining period on cognitive and functional performance of older adults at risk of frailty. Aging Clin Exp Res. 2025 Apr 7;37(1):117. doi: 10.1007/s40520-025-03011-w.
PubMed 40192885Subias-Perie J, Navarrete-Villanueva D, Fernandez-Garcia AI, Moradell A, Lozano-Berges G, Gesteiro E, Perez-Gomez J, Ara I, Gomez-Cabello A, Vicente-Rodriguez G, Casajus JA. Effects of a multicomponent training followed by a detraining period on metabolic syndrome profile of older adults. Exp Gerontol. 2024 Feb;186:112363. doi: 10.1016/j.exger.2024.112363. Epub 2024 Jan 19.
PubMed 38244708Fernandez-Garcia AI, Moradell A, Navarrete-Villanueva D, Subias-Perie J, Perez-Gomez J, Ara I, Gonzalez-Gross M, Casajus JA, Vicente-Rodriguez G, Gomez-Cabello A. Effects of Multicomponent Training Followed by a Detraining Period on Frailty Level and Functional Capacity of Older Adults with or at Risk of Frailty: Results of 10-Month Quasi-Experimental Study. Int J Environ Res Public Health. 2022 Sep 29;19(19):12417. doi: 10.3390/ijerph191912417.
PubMed 36231712Fernandez-Garcia AI, Gomez-Cabello A, Gomez-Bruton A, Moradell A, Navarrete-Villanueva D, Perez-Gomez J, Gonzalez-Gross M, Ara I, Casajus JA, Vicente-Rodriguez G. Effects of multicomponent training and detraining on the fitness of older adults with or at risk of frailty: results of a 10-month quasi-experimental study. Eur J Sport Sci. 2023 Aug;23(8):1696-1709. doi: 10.1080/17461391.2022.2104657. Epub 2022 Aug 11.
PubMed 35876120Moradell A, Fernandez-Garcia AI, Navarrete-Villanueva D, Perez-Gomez J, Gesteiro E, Ara Royo I, Casajus JA, Gomez-Cabello A, Vicente-Rodriguez G. Does nutritional status influence the effects of a multicomponent exercise programme on body composition and physical fitness in older adults with limited physical function? Eur J Sport Sci. 2023 Jul;23(7):1375-1384. doi: 10.1080/17461391.2022.2092426. Epub 2022 Jul 11.
PubMed 35816744
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Fitness Body Composition and Frailty in Elderly People Above 65 Years. Mediation of Vitamin D and Exercise Program Effects. EXERNET Elder 3.0
- ClinicalTrials.gov ID
- NCT03831841
- Acronym / sponsor ID
- EXERNETElder / EXERNET Elder 3.0
- Conditions
- Frail Elderly Syndrome, Sarcopenia, Physical Activity
- Keywords
- elderly, multicomponent exercise, body composition, vitamin D, fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 4 Dec 2019 (actual)
- First posted
- 6 Feb 2019 (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.
One of the major changes occurring in developed societies is a significant ageing of the population. Nowadays, because of an enhanced life expectancy, 17% of the Spanish population is composed of people over 65 and the number is expected to rise to 33% in 2050. Aging is characterized by a gradual lifelong accumulation of molecular and cellular damage that results in a progressive and generalized impairment in several bodily functions, an increased vulnerability to environmental challenges and a growing risk of disease and risk of death. These facts led to an increase on the prevalence of diseases such as osteoporosis diabetes, sarcopenia, obesity or frailty. However, lifestyles such as physical activity could attenuated aging process, maintaining the autonomy of elders, and it has been demonstrated that even implying guided exercise programs could reverse this condition of frailty and dependence.
In this way, the main aims of this research project are to analyze the effect of a multicomponent exercise program in frailty and pre-frailty people above 65 years and without cognitive impairment. Thus, it is going to be evaluated at the beginning and the end of the study; body composition, physical fitness, blood parameters including vitamin D and other health related parameters included in a questionnaire. Secondly, to study the perdurability of training-related gains over time.
Detailed description
The training will consist in a multicomponent exercise program, 3 days a week (Monday, Wednesday and Friday). It will take place during morning in groups of 10-14 and trainers will be qualified. Alll the exercise will be adapted for different levels of frailty and for their functional capacity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Multicomponent exercise programeMulticomponent exercise programe involving all physical fitness paramenters and consisting on sesions of 1 hour, 3 days a week. |
| Control | No intervention | –Control group with no intervention programe |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Above 65 years
- frailty of pre-frailty by SPPB.
Key exclusion criteria (1 listed)
- Severe cognitive impairment
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 |
|---|---|---|
| Multicomponent exercise programeAn intervention consisting of training by a multicomponent program 3 times a week, working on aerobic capacity, flexibility, balance and strength. | Behavioural | Intervention |
Primary outcome
Change in SPPB
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Short Physical Performance Battery by Romberg (SPPB): consist of walking 4m, a balance test with three levels (tandem, semi-tandem and stand up on one foot) and sit up and reach 5 times as fast as possible. Each test could point from 0 to 4, reaching a maximum of 12 months in the battery. Puntuation correspond to; 0-4 points the person is not valid, from 4 to 6 frails and form 7-9 pre-frailt
Change in Senior fitness test physical performance battery
Time frame: Change from Baseline at 3 months, 6 months and 12 months
A fitness test battery in order to measured physical performance of elderly, it includes: flamingos test (for balance), 30m of walking speed, 30 seconds of sit and reach (strength of lower extremities), 30sconds of arm curl, 6 minutes test (aerobic capacity), sit-up and go test (agility), flexibility of upper and lower extremities. Results are registered without puntuation.
Change of 25-OH Vitamin D concentrations
Time frame: Change from Baseline at 3 months, 6 months and 12 months
25-OH Vitamin D concentration in blood test
47 secondary outcomes
Changes on Fried Scale
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on Leucocites
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on Linfocites
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on hemoglobine
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on platelets
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on calcium
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on Cholesterol
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on HDL-Cholesterol
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on LDL-Cholesterol
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on Trigicerids
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on uric acid
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on urea
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on creatine
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on creatine kinasa
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on glucose
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on lactate deydrogenase
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on potasium
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on magnesium
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on transferrine
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on albumin
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on protein c reative
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on Bone mass and structure by perifereal quantitative computed tomography
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on hip perimeter
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Change on wrist perimeter
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Change on calf perimeter
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on arm relaxed perimeter
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on weight
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on body fat
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on efat percentage
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on height
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on Unkle-Brachial Index
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on FRAIL Scale
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on Clinical frailty scale
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on Sociotype Questionnaire for geriatric population
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on Physical Activity Questionnnaire for the Elder (PASE)
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on Insomnia Severity Index Score
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on Incontinence Urinary Questionnaire
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on EUROQOL (EQ-5D)
Time frame: Change from Baseline at 3 months, 6 months and 12 months
Changes on Use of hospital Resources
Time frame: Change from Baseline, 6 months and 12 months
Change Lawton and Brody Index
Time frame: Change from Baseline at 3 months, 6 months and 12 months
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 2 Jul 2020.
- Derived from this study: PubMed 41015204Subias-Perie J, Navarrete-Villanueva D, Fernandez-Garcia AI, Moradell A, Alcala-Nalvaiz JT, Groessl EJ, Ara I, Vila-Maldonado S, Perez-Gomez J, Gonzalez-Gross M, Gomez-Cabello A, Vicente-Rodriguez G, Casajus JA. Cost-effectiveness of a multicomponent training programme for older adults with decreased functional capacity: An economic evaluation. Exp Gerontol. 2025 Nov;211:112911. doi: 10.1016/j.exger.2025.112911. Epub 2025 Sep 25.
- Derived from this study: PubMed 40192885Moradell A, Iguacel I, Navarrete-Villanueva D, Fernandez-Garcia AI, Gonzalez-Gross M, Perez-Gomez J, Ara I, Casajus JA, Gomez-Cabello A, Vicente-Rodriguez G. Effects of a multicomponent training and a detraining period on cognitive and functional performance of older adults at risk of frailty. Aging Clin Exp Res. 2025 Apr 7;37(1):117. doi: 10.1007/s40520-025-03011-w.
- Derived from this study: PubMed 38244708Subias-Perie J, Navarrete-Villanueva D, Fernandez-Garcia AI, Moradell A, Lozano-Berges G, Gesteiro E, Perez-Gomez J, Ara I, Gomez-Cabello A, Vicente-Rodriguez G, Casajus JA. Effects of a multicomponent training followed by a detraining period on metabolic syndrome profile of older adults. Exp Gerontol. 2024 Feb;186:112363. doi: 10.1016/j.exger.2024.112363. Epub 2024 Jan 19.
- Derived from this study: PubMed 36231712Fernandez-Garcia AI, Moradell A, Navarrete-Villanueva D, Subias-Perie J, Perez-Gomez J, Ara I, Gonzalez-Gross M, Casajus JA, Vicente-Rodriguez G, Gomez-Cabello A. Effects of Multicomponent Training Followed by a Detraining Period on Frailty Level and Functional Capacity of Older Adults with or at Risk of Frailty: Results of 10-Month Quasi-Experimental Study. Int J Environ Res Public Health. 2022 Sep 29;19(19):12417. doi: 10.3390/ijerph191912417.
- Derived from this study: PubMed 35876120Fernandez-Garcia AI, Gomez-Cabello A, Gomez-Bruton A, Moradell A, Navarrete-Villanueva D, Perez-Gomez J, Gonzalez-Gross M, Ara I, Casajus JA, Vicente-Rodriguez G. Effects of multicomponent training and detraining on the fitness of older adults with or at risk of frailty: results of a 10-month quasi-experimental study. Eur J Sport Sci. 2023 Aug;23(8):1696-1709. doi: 10.1080/17461391.2022.2104657. Epub 2022 Aug 11.
- Derived from this study: PubMed 35816744Moradell A, Fernandez-Garcia AI, Navarrete-Villanueva D, Perez-Gomez J, Gesteiro E, Ara Royo I, Casajus JA, Gomez-Cabello A, Vicente-Rodriguez G. Does nutritional status influence the effects of a multicomponent exercise programme on body composition and physical fitness in older adults with limited physical function? Eur J Sport Sci. 2023 Jul;23(7):1375-1384. doi: 10.1080/17461391.2022.2092426. Epub 2022 Jul 11.
- Individual participant dataSharing planned: No
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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 Multicomponent exercise programe in people with Frail Elderly Syndrome and Sarcopenia, 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 2 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 2 Jul 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 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?
Change in SPPB (time frame: Change from Baseline at 3 months, 6 months and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03831841, which also lists 6 linked publications.
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 2 Jul 2020.