Clinical trial NCT03831841: Physical Fitness, Body Composition and Frailty in Elderly People.Exercise Program Effecsts. EXERNET Elder 3.0
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly Syndrome
Sarcopenia
Physical Activity
Keywords: elderly
multicomponent exercise
body composition
vitamin D
fitness
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 110
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Severe cognitive impairment

Primary outcomes:
measure: Change in SPPB
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Change in Senior fitness test physical performance battery
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Change of 25-OH Vitamin D concentrations
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
Secondary outcomes:
measure: Changes on Fried Scale
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on Leucocites
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on Linfocites
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on hemoglobine
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on platelets
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on calcium
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on Cholesterol
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on HDL-Cholesterol
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on LDL-Cholesterol
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on Trigicerids
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on uric acid
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on urea
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on creatine
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on creatine kinasa
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on glucose
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on lactate deydrogenase
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on potasium
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on magnesium
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on transferrine
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on albumin
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on protein c reative
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on Bone mass and structure by perifereal quantitative computed tomography
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on hip perimeter
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Change on wrist perimeter
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Change on calf perimeter
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on arm relaxed perimeter
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on weight
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on body fat
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on efat percentage
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on height
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on Unkle-Brachial Index
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on FRAIL Scale
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on Clinical frailty scale
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on Sociotype Questionnaire for geriatric population
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on Physical Activity Questionnnaire for the Elder (PASE)
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on Insomnia Severity Index Score
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on Incontinence Urinary Questionnaire
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on EUROQOL (EQ-5D)
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on Use of hospital Resources
timeFrame: Change from Baseline, 6 months and 12 months
measure: Change Lawton and Brody Index
timeFrame: Change from Baseline at 3 months, 6 months and 12 months
measure: Changes on Barthel Index
timeFrame: Change from Baseline at 3 months, 6 months and 12 months.
measure: Change on Risk of falls and Fear to Fall Assesment
timeFrame: Change from Baseline at 3 months, 6 months and 12 months.
measure: Change Sun Expousure Questionnaire
timeFrame: Change from Baseline at 3 months, 6 months and 12 months.
measure: Change on Mediterranean Adherence Questionnaire PREDIMED
timeFrame: Change from Baseline at 3 months, 6 months and 12 months.
measure: Changes on Mini Nutritional Assesment
timeFrame: Change from Baseline at 3 months, 6 months and 12 months.
measure: Changes on ExernetElder questionnaire
timeFrame: Change from Baseline at 6 months and 12 months.
measure: Change on Food Frequency Questionnaire
timeFrame: Baseline
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Universidad de Zaragoza
Study officials:
References:
citation: Fernandez-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.
citation: Moradell 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.