Clinical trial NCT04118478: Effect of a Multi-component Training Program With Progressive Phases on the Elderly
Official title: Effects of Multicomponent Exercise Program With Progressive Phases on Functional Capacity, Fitness, Quality of Life, Dual-Task and Physiological Variables in Older Adults: Randomized Controlled Trial Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ELDERLY PEOPLE
Keywords: fitness
program training
exercise
health
physical condition
qualilty of Life
Functional capacity
physiological status
physical activity
elderly
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 102
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A study protocol of a randomized controlled clinical trial with blinded examiners is presented.
Primary purpose: PREVENTION

Brief summary: The increase in life expectancy worldwide, added to the decrease in birth rates, has resulted in an increase in the aging population. In the case of Chile, 11.4% of its inhabitants are older adults and specifically, in the Til-Til commune, 14.65% of the total population is over 60 years of age, directly affecting the neuromuscular system and mainly cardiorespiratory. Therefore, the older person lives longer, but with a lower quality of life. Physical exercise appears as a non-pharmacological alternative to improve the quality of life, physical and cognitive functions. The "multi-component training" consists of a program that combines strength, resistance, balance and gait training, and is the one that presents the greatest improvements in the functional capacity of the elderly person.

The objective of the present investigation is to relate the effects of a multi-component training schedule by phases on the quality of life, functional capacity and physiological parameters in a group of people over 60 to 80 years of age in the commune of Til-Til.

Detailed description: The intervention consists of carrying out a 27-week multi-component training program divided into 3 phases of 9 weeks each, where the physical qualities will be progressively worked together twice a week. However, in each phase the development of one physical quality will predominate over the others. Each session will be supervised by two experienced physical educators in the area, they will also be trained two weeks prior to the intervention and supervised weekly by the principal investigator. The first phase will have as its main objective to develop strength, through exercises with overload and in turn, it will be subdivided into 3 blocks of 3 weeks each: Neuromuscular adaptation (block 1), muscular power (block 2), muscular resistance (block 3). Each session will last approximately 45 minutes at an intensity of 70-75% of one maximum repetition (1RM) and with an effort character from light to maximum. The session will consist of 10 minutes of mobility and muscle activation as a warm-up, 25 minutes of strength exercises and 10 minutes of stretching as a return to calm. The second phase will have as its main objective to develop cardiorespiratory capacity through intermittent gait training and, in turn, will be subdivided into 3 blocks of 3 weeks each: Static gait (block 1), dynamic gait (block 2) and dynamic gait with changes of direction (block 3). Each session will last approximately 50 minutes with an effort perception of 6-8. The session will consist of 10 minutes of mobility and muscular activation as a warm-up, 10 minutes of muscular power exercises, 20 minutes of cardiorespiratory endurance and 10 minutes of stretching as a return to calm. The last phase will have as its main objective to develop balance and flexibility, by strengthening the stabilizing muscles and range of motion. In turn, this phase will be subdivided into 3 blocks of 3 weeks each: Balance / static flexibility (block 1), balance / dynamic flexibility (block 2) and balance / flexibility with a double task (block 3). Each session will last approximately 60 minutes with a perception of effort of 6-8. The session will consist of 10 minutes of mobility and muscle activation as a warm-up, 10 minutes of power exercises, 10 minutes of cardiorespiratory endurance, 20 minutes of balance exercises and 10 minutes of stretching as a return to calm).

Eligibility criteria: The inclusion criteria are: a) being between 60 to 80 years old, b) being able to move with or without personal / technical assistance, c) able to communicate, d) autonomy to give consent or, otherwise, be assisted by a relative or legal representative. Exclusion criteria are any factors that exclude the performance of the physical training program or testing procedures as determined by the treating physician. These factors include, but are not limited to, the following: a) terminal disease, b) acute myocardial infarction in the past 3 months, c) unstable cardiovascular disease or other medical condition, d) fracture of the upper or lower extremity in the last 3 months, e) severe dementia, f) unwillingness to complete study requirements or to be randomized to the control or intervention group.

Primary outcomes:
measure: Assessment of the quality of life
timeFrame: Change from Baseline quality life at 2, 4 and at 6 month
measure: Heart rate variability
timeFrame: Change from Baseline Heart rate variability at 2, 4 and at 6 month
measure: Spirometry, forced expiratory volume in one second (FEV1)
timeFrame: Change from Baseline Spirometry FEV1 at 2, 4 and at 6 month
measure: Spirometry, peak expiratory flow (PEF)
timeFrame: Change from Baseline Spirometry PEF at 2, 4 and at 6 month
measure: Resting Heart rate
timeFrame: Change from Baseline Resting Heart rate at 2, 4 and at 6 month
measure: Resting blood pressure
timeFrame: Change from resting blood pressure at 2, 4 and at 6 month
measure: Short Physical Performance Battery (SPPB)
timeFrame: Change from Baseline SPPB at 2, 4 and at 6 month
measure: Walking speed in 4 and 6 meters
timeFrame: Change from Baseline Walking speed in 4 and 6 meters at 2, 4 and at 6 month
measure: Time Up and Go
timeFrame: Change from Baseline Time Up and Go at 2, 4 and at 6 month
measure: Dynamometry
timeFrame: Change from Baseline Dynamometry at 2, 4 and at 6 month
measure: Walking While Talking (WWT)
timeFrame: Change from Baseline Walking While Talking at 2, 4 and at 6 month
measure: Two minutes "Step test"
timeFrame: Change from Baseline Two minutes "Step test" at 2, 4 and at 6 month
measure: Sit and reach test
timeFrame: Change from Baseline Sit and reach test at 2, 4 and at 6 month
measure: Back scratch test
timeFrame: Change from Baseline Back scratch test at 2, 4 and at 6 month
Secondary outcomes:
measure: Motivation for the exercise
timeFrame: Change from Baseline Motivation for the exercise at 6 month
measure: "Physical Activity Vital Sign" (PAVS)
timeFrame: Change from Baseline "Physical Activity Vital Sign" at 6 month
measure: "Stanford Short Activity Survey"
timeFrame: Change from Baseline "Stanford Short Activity Survey" at 6 month
measure: Abdominal circumference
timeFrame: Change from Baseline Abdominal circumference at 2, 4 and at 6 month
measure: Electrical impedance
timeFrame: Change from Baseline Electrical impedance at 2, 4 and at 6 month
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Universidad Catolica de murcia
Study officials:
affiliation: UCAM
name: Emilio Jofré-Saldía, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: UCAM
name: Gemma García, Phd
role: STUDY_DIRECTOR
affiliation: University of Ibadan Teaching Hospital (UCH)
name: Alvaro Villalobos, Msc
role: PRINCIPAL_INVESTIGATOR
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