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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05331794
Other study ID # CE111908
Secondary ID RTC-2017-6145-1
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date June 2022
Est. completion date July 2022

Study information

Verified date May 2022
Source Universidad Católica San Antonio de Murcia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Aging causes various changes in the body. This, together with a sedentary lifestyle, can lead to health problems such as loss of muscle mass and strength, bone mineral density and cardiovascular capacity. Therefore, it is essential to remain physically active in adulthood. Outdoor fitness equipment offer a free and easy-to-use option for physical activity and health improvement. However, there are few studies that quantitatively evaluate the physical fitness and health improvement associated with the use of these parks. Hence, the main objective is: 1) To evaluate the effects of training on outdoor fitness equipment on different body composition and health-related fitness parameters.


Description:

Physiological, psychological and functional deterioration is associated with the aging process. It has been demonstrated that the practice of physical activity can prevent, slow or reduce this deterioration. Bio-healthy parks are an alternative for practicing physical activity outdoors and free of charge. However, there is no research that analyzes the effect of a planned training program in these parks. Therefore, the objectives of this project are 1) To evaluate the effects of training on outdoor fitness equipment on different body composition and health-related fitness parameters. The present project will be developed through a randomized controlled trial, with 1 experimental and 1 control group, with pre-test and post-test, with intra-group and inter-group analysis for each of the dependent variables of the study. The inclusion criteria are: (a) not having participated in a structured exercise program for at least 1 year, (b) being older than 50 years of age, and (c) being physically independent. The exclusion criteria are: (a) having musculoskeletal injuries or limitations that could affect the health and physical performance of the person; (b) being under medical prescription for taking medications that could influence physical performance; (c) not regularly attending the proposed sessions. Body composition and bone mineral density will be assessed by dual energy X-ray absorptiometry (DEXA). Blood pressure by means of an automatic device (Colin BP 880, Inc., Tampa, FL). Strength by manual dynamometry (TKK 5401; Co., Ltd., Tokyo, Japan) and maximal isometric strength of knee extension and biceps flexion. Functional capacity will be assessed by means of the Chari stand test, gait speed, time up and go test and Short physical performance battery (SPPB), Sarcopenia will be assessed taking into account the reference values established for muscle quality (hand grip strength and chair stand test), muscle quantity (DEXA fat-free mass) and functional competence (gait speed, time up and go test, SPPB and 400 meter walk) established by the European Consensus (EWGSOP2). The Spinal Mouse device (Switzerland) will be used to assess the sagittal disposition of the spine (thoracic curve, lumbar curve and pelvic tilt) in standing and relaxed sitting. This technique is non-invasive. Health-related quality of life and satisfaction with life will be assessed by means of the SF36 and The Satisfaction with Life Scale (SWL) questionnaires. Mediterranean diet adherence will be assess with a Mediterranean diet adherence questionaire. Experimental group 1 will receive the exercise program on bio-healthy machinery with a frequency of 2 sessions per week of 55 minutes for 8 weeks. The machines used will be rider, low gemini, high gemini, walk, bottoms, flywheels circles, flywheels rotation, twin swing, surf, swing press and rowing. Intensity will be controlled by subjective perception of effort and heart rate (Polar 420). There will be a warm-up 8-10 minutes, a main part 40-45 minutes and a return to calm 5-10 minutes. The intervention programs will be developed by a graduate in Physical Activity and Sport Sciences. The load will be progressed every 2 weeks. The control group will not perform any intervention program following their usual activity.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 70
Est. completion date July 2022
Est. primary completion date June 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Not present any surgery, pathology or condition that prevents the practice of physical activity or may interfere with the results of the tests. - Do not present any acute infection in the last 2 weeks. - Do not having carried out physical exercise similar to that performed during intervention. Exclusion Criteria: - Have answered "yes" to any of the items of the Physical Activity Readiness Questionnaire (PAR-Q). - Have a medical contraindication to exercise. - Failure to complete or attend training or measurements sessions during the intervention. - Practice regular physical exercise outside the intervention or change habits that may influence the tests.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Training on BIOFIT-Park
Participant will perform one strength training session on the new line of outdoor fitness equipment "BIOFIT-Park". 6 machines will be used. The training will consist of 3 sets of 15-20 repetitions, working at 60-65% RM. The execution speed will be 1x1, the rest between machines will be 20 seconds and macropauses of 90 seconds between series.
Training on gym park equipament
Participant will perform one strength training session on a gym park equipment. 6 machines will be used. The training will consist of 3 sets of 15-20 repetitions, working at 60-65% RM. The execution speed will be 1x1, the rest between machines will be 20 seconds and macropauses of 90 seconds between series.

Locations

Country Name City State
Spain Universidad Católica San Antonio Murcia

Sponsors (1)

Lead Sponsor Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rest Metabolic Rate Evaluation of resting metabolic rate through an indirect calorimetry test. Pre-test
Primary Heart Rate Variability Evaluation of changes in heart rate variability index measured via a heart rate monitor band. Pre-test and post-test
Primary Blood Pressure Non-invasive evaluation of systolic and diastolic peripheral blood pressure changes. Pre-test and post-test
Primary Counter Movement Jump Test Evaluation of explosive force in lower limb through vertical jump height in centimetres. Pre-test and post-test
Primary Knee Extension Rate of Foce Development Strength Test Evaluation of force production capacity per unit time through a dynamometer on a seated leg extension machine. Pre-test and post-test
Primary Knee Extension Strength Test Evaluation of the maximum voluntary contraction (MVC) of the quadriceps through a dynamometer on a seated leg extension machine. Pre-test and post-test
Primary Arm Curl Strength Test Evaluation of the maximum voluntary contraction (MVC) of the elbow flexor muscles through a dynamometer in standing position. Pre-test and post-test
Primary Lactate Blood Test Evaluation of serum lactate level (mmol/L) through a finger pick method Pre-test and post-test
Primary Excess Post-Exercise Oxygen Consumption Test Evaluation of excess post-exercise oxygen consumption (EPOC) during the minutes following exercise sessions through indirect calorimetry. Post-test
Primary Energy expenditure Evaluation of energy expenditure of participants during exercise through indirect calorimetry During exercise
Primary Heart rate Evaluation of heart rate measured via a heart rate monitor band. During exercise
Primary Subjective perception of effort Evaluation of subjective perception of effort by ONMI-RES scale. The scale goes from 1 to 10 and the subject reports on his subjective perception of effort, with 1 being the lowest value and 10 the highest value. During exercise
Secondary Sociodemographic questionnaire To define individual characteristics of participants such as age, gender or ethnicity. Pre-test
Secondary Global Physical Activity Questionnaire Questionnaire to evaluate the level of physical activity performed in the daily routine. The questionnaire collects information on the time in minutes and frequency per week of moderate and vigorous physical activity, walking and sedentary activities. A greater time of physical activity and walking; and less time spent in sedentary activities would be considered a better score. Pre-test
Secondary Dietary Recall Questionnaire 24-hour pre-intervention dietary intake recording instrument. Pre-test
Secondary Height Height will be assessed following the methodology proposed by the International Society for the Advancement of Kinathropometry (ISAK). The values will be expressed in meters. Pre-test
Secondary Weight and bone weight Weight and bone weight will be performance with BIA-derived body composition measurements. It will be reported as a kilograms. Pre-test
Secondary Percentaje of fat, hydration and muscle mass. Average of fat, hydration and muscle mass will be performance with BIA-derived body composition measurements. It will be reported as a percentaje. Pre-test
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