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

NCT03831841 | Completed

• 1 other identifier: EXERNET Elder 3.0
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Frail Elderly Syndrome; Sarcopenia; Physical Activity

Keywords

elderly; multicomponent exercise; body composition; vitamin D; fitness

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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

  Change from Baseline at 3 months, 6 months and 12 months

Secondary Outcomes (47)

• 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 Linfocites

  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 platelets

  Change from Baseline at 3 months, 6 months and 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Multicomponent exercise programe involving all physical fitness paramenters and consisting on sesions of 1 hour, 3 days a week.

Behavioral: Multicomponent exercise programe

Control

NO INTERVENTION

Control group with no intervention programe

Interventions

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.

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Severe cognitive impairment

Sponsors & Collaborators

• Universidad de Zaragoza: lead

Study Sites (1)

Universidad de Zaragoza

Zaragoza, 50009, Spain

Location

Related Publications (6)

• 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.

  PMID: 41015204 DERIVED

• Moradell 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.

  PMID: 40192885 DERIVED

• Subias-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.

  PMID: 38244708 DERIVED

• Fernandez-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.

  PMID: 36231712 DERIVED

• 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.

  PMID: 35876120 DERIVED

• 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.

  PMID: 35816744 DERIVED

MeSH Terms

Conditions

Sarcopenia; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior lecturer

Study Record Dates

• First Submitted: December 2, 2018
• First Posted: February 6, 2019
• Study Start: November 5, 2018
• Primary Completion: June 30, 2019
• Study Completion: December 4, 2019
• Last Updated: July 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)