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Completed

NCT Number: NCT03831841

Physical Fitness, Body Composition and Frailty in Elderly People.Exercise Program Effecsts. 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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Zaragoza

Zaragoza, 50009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Above 65 years
  • frailty of pre-frailty by SPPB.

Exclusion criteria

  • Severe cognitive impairment

Treatment and study plan

Multicomponent exercise programe

Behavioral

An intervention consisting of training by a multicomponent program 3 times a week, working on aerobic capacity, flexibility, balance and strength.

Primary outcomes

  1. 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

  2. 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.

  3. 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

Secondary outcomes

  1. Changes on Fried Scale

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    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.

  2. Changes on Leucocites

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Measured by blood test (%)

  3. Changes on Linfocites

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Measured by blood test (%)

  4. Changes on hemoglobine

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Measured by blood test (%)

  5. Changes on platelets

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Measured by blood test (10^3/uL)

  6. Changes on calcium

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Measured by blood test (mg/dL)

  7. Changes on Cholesterol

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Measured by blood test (mg/dL)

  8. Changes on HDL-Cholesterol

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Measured by blood test (mg/dL)

  9. Changes on LDL-Cholesterol

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Measured by blood test (mg/dL)

  10. Changes on Trigicerids

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Measured by blood test (mg/dL)

  11. Changes on uric acid

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Measured by blood test (mg/dL)

  12. Changes on urea

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Measured by blood test (mg/dL)

  13. Changes on creatine

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Measured by blood test (mg/dL)

  14. Changes on creatine kinasa

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Measured by blood test (U/dL)

  15. Changes on glucose

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Measured by blood test (mg/dL)

  16. Changes on lactate deydrogenase

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Measured by blood test (UI/dL)

  17. Changes on potasium

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Measured by blood test (mEq/dL)

  18. Changes on magnesium

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Measured by blood test (mg/dL)

  19. Changes on transferrine

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Measured by blood test (mg/dL)

  20. Changes on albumin

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Measured by blood test (g/dL)

  21. Changes on protein c reative

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Measured by blood test (mg/dL)

  22. Changes on Bone mass and structure by perifereal quantitative computed tomography

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Mass and structure of tibia (at 4, 38, 66 % slides) and radius (4, 66 % slides) by pQCT

  23. Changes on hip perimeter

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Hip perimeter measured following ISAK protocol. Centimeters

  24. Change on wrist perimeter

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Wrist perimeter following ISAK protocol. Centimeters

  25. Change on calf perimeter

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Calf perimeter following ISAK protocol. Centimeters

  26. Changes on arm relaxed perimeter

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Calf perimeter following ISAK protocol. Centimeters

  27. Changes on weight

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Change on kilograms by bioimpedance measurement (TANITA)

  28. Changes on body fat

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Change on kilograms by bioimpedance measurement (TANITA)

  29. Changes on efat percentage

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Change on % by bioimpedance measurement (TANITA)

  30. Changes on height

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    Change on height (cm)

  31. Changes on Unkle-Brachial Index

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    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.

  32. Changes on FRAIL Scale

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    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.

  33. Changes on Clinical frailty scale

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    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.

  34. Changes on Sociotype Questionnaire for geriatric population

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    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.

  35. Changes on Physical Activity Questionnnaire for the Elder (PASE)

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    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

  36. Changes on Insomnia Severity Index Score

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    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)

  37. Changes on Incontinence Urinary Questionnaire

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    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.

  38. Changes on EUROQOL (EQ-5D)

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    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.

  39. Changes on Use of hospital Resources

    Time frame: Change from Baseline, 6 months and 12 months

    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.

  40. Change Lawton and Brody Index

    Time frame: Change from Baseline at 3 months, 6 months and 12 months

    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.

  41. Changes on Barthel Index

    Time frame: Change from Baseline at 3 months, 6 months and 12 months.

    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.

  42. Change on Risk of falls and Fear to Fall Assesment

    Time frame: Change from Baseline at 3 months, 6 months and 12 months.

    Questionnaire about, have fear to fall, since when, give up activities because of fear and since when. No puntuation.

  43. Change Sun Expousure Questionnaire

    Time frame: Change from Baseline at 3 months, 6 months and 12 months.

    Questionnaire about hours expended outside, sun exposure and skin type. Only registration of data, without puntuations.

  44. Change on Mediterranean Adherence Questionnaire PREDIMED

    Time frame: Change from Baseline at 3 months, 6 months and 12 months.

    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.

  45. Changes on Mini Nutritional Assesment

    Time frame: Change from Baseline at 3 months, 6 months and 12 months.

    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.

  46. Changes on ExernetElder questionnaire

    Time frame: Change from Baseline at 6 months and 12 months.

    Questionnaire about sociodemographic aspects such as participation on sports during lifespan, menarchy age and menopause age.

    Descriptive registration.

  47. Change on Food Frequency Questionnaire

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Registry information

Official study 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

Acronym: EXERNETElder

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 6, 2019
Registry last updated
Jul 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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