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Physical Fitness, Body Composition and Frailty in Elderly People.Exercise Program Effecsts. EXERNET Elder 3.0 (EXERNETElder)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03831841
Recruitment Status : Completed
First Posted : February 6, 2019
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
German Vicente-Rodríguez, Universidad de Zaragoza

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment Phase
Frail Elderly Syndrome Sarcopenia Physical Activity Behavioral: Multicomponent exercise programe Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 5, 2018
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : December 4, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
Multicomponent exercise programe involving all physical fitness paramenters and consisting on sesions of 1 hour, 3 days a week.
 Behavioral: Multicomponent exercise programe
An intervention consisting of training by a multicomponent program 3 times a week, working on aerobic capacity, flexibility, balance and strength.
No Intervention: Control
Control group with no intervention programe


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe cognitive impairment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831841


Locations
Layout table for location information
Spain
Universidad de Zaragoza
Zaragoza, Spain, 50009
Sponsors and Collaborators
Universidad de Zaragoza
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: German Vicente-Rodríguez, Senior lecturer, Universidad de Zaragoza
ClinicalTrials.gov Identifier: NCT03831841    
Other Study ID Numbers: EXERNET Elder 3.0
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by German Vicente-Rodríguez, Universidad de Zaragoza:
elderly
multicomponent exercise
body composition
vitamin D
fitness
Additional relevant MeSH terms:
Layout table for MeSH terms
Sarcopenia
Frailty
Pathologic Processes
Muscular Atrophy
Neuromuscular Manifestations
 Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical