Physical Fitness Body Composition and Frailty in Elderly People Above 65 Years. Mediation of Vitamin D and Exercise Program Effects. EXERNET Elder 3.0
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Frail Elderly Syndrome
- Sponsor
- Universidad de Zaragoza
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Change in Senior fitness test physical performance battery
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
German Vicente-Rodríguez
Senior lecturer
Universidad de Zaragoza
Eligibility Criteria
Inclusion Criteria
- •Above 65 years
- •frailty of pre-frailty by SPPB.
Exclusion Criteria
- •Severe cognitive impairment
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- Changes on Fried Scale(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on Leucocites(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on hemoglobine(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on glucose(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on lactate deydrogenase(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on transferrine(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on protein c reative(Change from Baseline at 3 months, 6 months and 12 months)
- Change on wrist perimeter(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on calcium(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on creatine(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on creatine kinasa(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on magnesium(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on albumin(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on FRAIL Scale(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on Clinical frailty scale(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on Insomnia Severity Index Score(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on Incontinence Urinary Questionnaire(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on platelets(Change from Baseline at 3 months, 6 months and 12 months)
- Change on Risk of falls and Fear to Fall Assesment(Change from Baseline at 3 months, 6 months and 12 months.)
- Changes on Cholesterol(Change from Baseline at 3 months, 6 months and 12 months)
- Change on calf perimeter(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on efat percentage(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on Unkle-Brachial Index(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on Barthel Index(Change from Baseline at 3 months, 6 months and 12 months.)
- Changes on Trigicerids(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on Linfocites(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on uric acid(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on urea(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on potasium(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on hip perimeter(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on weight(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on EUROQOL (EQ-5D)(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on HDL-Cholesterol(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on LDL-Cholesterol(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on Bone mass and structure by perifereal quantitative computed tomography(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on arm relaxed perimeter(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on body fat(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on height(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on Use of hospital Resources(Change from Baseline, 6 months and 12 months)
- Change Lawton and Brody Index(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on Sociotype Questionnaire for geriatric population(Change from Baseline at 3 months, 6 months and 12 months)
- Changes on Physical Activity Questionnnaire for the Elder (PASE)(Change from Baseline at 3 months, 6 months and 12 months)
- Change Sun Expousure Questionnaire(Change from Baseline at 3 months, 6 months and 12 months.)
- Change on Mediterranean Adherence Questionnaire PREDIMED(Change from Baseline at 3 months, 6 months and 12 months.)
- Changes on Mini Nutritional Assesment(Change from Baseline at 3 months, 6 months and 12 months.)
- Changes on ExernetElder questionnaire(Change from Baseline at 6 months and 12 months.)
- Change on Food Frequency Questionnaire(Baseline)