Physical InactivityNCT05331794
Effects of Training on Outdoor Fitness Equipment for Health Improvement
A study testing Training on BIOFIT-Park and Training on gym park equipament in people with Physical Inactivity and Healthy, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Healthy
- What is being tested?
- Training on BIOFIT-Park and Training on gym park equipament
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2022to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Design and Development of a New Line of Outdoor Fitness Equipment: "BIOFIT-Park" A Study on Ergonomics, Safety and Efficiency
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.
Read the detailed 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.
- Conditions
- Physical Inactivity, Healthy
- Being tested
- Training on BIOFIT-Park, Training on gym park equipament
- Keywords
- Outdoor fitness equipment, Outdoor gym, Physical fitness
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training on BIOFIT-ParkBehavioural
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 equipamentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: "BIOFIT-Park" outdoor fitness equipment | Experimental | Refers to an arm that trains on the "BIOFIT-Park" line of outdoor fitness equipment that is currently under development and testing. Receives: Behavioral: Training on BIOFIT-Park |
| Experimental: Gym park equipment | Experimental | Refers to an arm that trains on gym park equipment Receives: Behavioral: Training on gym park equipament |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rest Metabolic Rate
Evaluation of resting metabolic rate through an indirect calorimetry test.
Measured: Pre-test
Heart Rate Variability
Evaluation of changes in heart rate variability index measured via a heart rate monitor band.
Measured: Pre-test and post-test
Blood Pressure
Non-invasive evaluation of systolic and diastolic peripheral blood pressure changes.
Measured: Pre-test and post-test
Counter Movement Jump Test
Evaluation of explosive force in lower limb through vertical jump height in centimetres.
Measured: Pre-test and post-test
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.
Measured: Pre-test and post-test
Knee Extension Strength Test
Evaluation of the maximum voluntary contraction (MVC) of the quadriceps through a dynamometer on a seated leg extension machine.
Measured: Pre-test and post-test
Arm Curl Strength Test
Evaluation of the maximum voluntary contraction (MVC) of the elbow flexor muscles through a dynamometer in standing position.
Measured: Pre-test and post-test
Lactate Blood Test
Evaluation of serum lactate level (mmol/L) through a finger pick method
Measured: Pre-test and post-test
Excess Post-Exercise Oxygen Consumption Test
Evaluation of excess post-exercise oxygen consumption (EPOC) during the minutes following exercise sessions through indirect calorimetry.
Measured: Post-test
Energy expenditure
Evaluation of energy expenditure of participants during exercise through indirect calorimetry
Measured: During exercise
Heart rate
Evaluation of heart rate measured via a heart rate monitor band.
Measured: During exercise
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.
Measured: During exercise
Secondary outcomes (6)
Sociodemographic questionnaire
To define individual characteristics of participants such as age, gender or ethnicity.
Measured: Pre-test
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.
Measured: Pre-test
Dietary Recall Questionnaire
24-hour pre-intervention dietary intake recording instrument.
Measured: Pre-test
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.
Measured: Pre-test
Weight and bone weight
Weight and bone weight will be performance with BIA-derived body composition measurements. It will be reported as a kilograms.
Measured: Pre-test
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.
Measured: Pre-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start1 Jun 2022
- Primary completion15 Jun 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noelia González-Gálvez, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331794
- Sponsor's protocol ID
- CE111908
- Other IDs
- RTC-2017-6145-1
- Status last verified
- May 2024
- First submitted
- 12 Nov 2021
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Development of a New Line of Outdoor Fitness Equipment: "BIOFIT-Park" A Study on Ergonomics, Safety and Efficiency
- ClinicalTrials.gov ID
- NCT05331794
- Acronym / sponsor ID
- CE111908
- Conditions
- Physical Inactivity, Healthy
- Keywords
- Outdoor fitness equipment, Outdoor gym, Physical fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: "BIOFIT-Park" outdoor fitness equipment | Experimental | Behavioral: Training on BIOFIT-ParkRefers to an arm that trains on the "BIOFIT-Park" line of outdoor fitness equipment that is currently under development and testing. |
| Experimental: Gym park equipment | Experimental | Behavioral: Training on gym park equipamentRefers to an arm that trains on gym park equipment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training on BIOFIT-ParkParticipant 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. | Behavioural | Experimental: "BIOFIT-Park" outdoor fitness equipment |
| Training on gym park equipamentParticipant 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. | Behavioural | Experimental: Gym park equipment |
Primary outcome
Rest Metabolic Rate
Time frame: Pre-test
Evaluation of resting metabolic rate through an indirect calorimetry test.
Heart Rate Variability
Time frame: Pre-test and post-test
Evaluation of changes in heart rate variability index measured via a heart rate monitor band.
Blood Pressure
Time frame: Pre-test and post-test
Non-invasive evaluation of systolic and diastolic peripheral blood pressure changes.
Counter Movement Jump Test
Time frame: Pre-test and post-test
Evaluation of explosive force in lower limb through vertical jump height in centimetres.
Knee Extension Rate of Foce Development Strength Test
Time frame: Pre-test and post-test
Evaluation of force production capacity per unit time through a dynamometer on a seated leg extension machine.
Knee Extension Strength Test
Time frame: Pre-test and post-test
Evaluation of the maximum voluntary contraction (MVC) of the quadriceps through a dynamometer on a seated leg extension machine.
Arm Curl Strength Test
Time frame: Pre-test and post-test
Evaluation of the maximum voluntary contraction (MVC) of the elbow flexor muscles through a dynamometer in standing position.
Lactate Blood Test
Time frame: Pre-test and post-test
Evaluation of serum lactate level (mmol/L) through a finger pick method
Excess Post-Exercise Oxygen Consumption Test
Time frame: Post-test
Evaluation of excess post-exercise oxygen consumption (EPOC) during the minutes following exercise sessions through indirect calorimetry.
Energy expenditure
Time frame: During exercise
Evaluation of energy expenditure of participants during exercise through indirect calorimetry
Heart rate
Time frame: During exercise
Evaluation of heart rate measured via a heart rate monitor band.
Subjective perception of effort
Time frame: During exercise
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.
6 secondary outcomes
Sociodemographic questionnaire
Time frame: Pre-test
Global Physical Activity Questionnaire
Time frame: Pre-test
Dietary Recall Questionnaire
Time frame: Pre-test
Height
Time frame: Pre-test
Weight and bone weight
Time frame: Pre-test
Percentaje of fat, hydration and muscle mass.
Time frame: Pre-test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training on BIOFIT-Park and Training on gym park equipament in people with Physical Inactivity and Healthy, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rest Metabolic Rate (time frame: Pre-test). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.