Clinical trial NCT04958499: Effectiveness of Bio-Healthy Park on Adult
Official title: Physical and Psychological Effectiveness of Bio-Healthy Park on Adult
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult Disease
Keywords: Adults
Older
Physical activity
Exercise
Bio-healthy park
Training
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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. There are two types of parks under development, with and without externally added resistance. Therefore, general objective of this project are to evaluate the effect of 8 weeks of targeted training in bio-healthy parks on body composition, bone mineral density, blood pressure, strength, functional capacity, sarcopenia, sagittal disposition of the spine, quality of life, life satisfaction and Mediterranean diet adherence in adults and older adults. 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. It will be measure body composition, bone mineral density, blood pressure, upper limb strength, lower limb strength, functional capacity, sarcopenia, sagittal disposition of the spine, Health-related quality of life, satisfaction with life and Mediterranean diet adherence. Experimental group will receive the exercise program on bio-healthy park machine with a frequency of 2 sessions per week of 55 minutes for 8 weeks. The control group will not perform any intervention program following their usual activity.

Detailed description: The aging process is associated with physiological, psychological and functional deterioration. 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. There are two types of parks under development, with and without externally added resistance.

Therefore, the objectives of this project are to evaluate the effect of 8 weeks of targeted training in bio-healthy parks, with a frequency of 2 sessions per week on body composition, bone mineral density, blood pressure, strength, functional capacity, sarcopenia, sagittal disposition of the spine, quality of life, life satisfaction and mediterranean diet satisfaction in adults and older adults.

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.

Eligibility criteria: Inclusion Criteria:

* not having participated in a structured exercise program for at least 1 year;
* being older than 50 years of age
* being physically independent.

Exclusion Criteria:

* having musculoskeletal injuries or limitations that could affect the person's health and physical performance
* being under medical prescription for taking medications that could influence physical performance
* not regularly attending the proposed sessions.

Primary outcomes:
measure: Muscle quality sarcopenia
timeFrame: Changes from baseline to 8 weeks
Secondary outcomes:
measure: Change Body composition
timeFrame: Changes from baseline to 8 weeks
measure: Change Blood pressure
timeFrame: Changes from baseline to 8 weeks
measure: Change Chair stand test
timeFrame: Changes from baseline to 8 weeks
measure: Change Upper strength
timeFrame: Changes from baseline to 8 weeks
measure: Change Sagittal spinal curvature
timeFrame: Changes from baseline to 8 weeks
measure: Health-related quality
timeFrame: Changes from baseline to 8 weeks
measure: Satisfaction with Life Scale (SWL)
timeFrame: Changes from baseline to 8 weeks
measure: Adherence to the Mediterranean diet
timeFrame: Changes from baseline to 8 weeks
measure: Functional competence 400 meter walk
timeFrame: Changes from baseline to 8 weeks
measure: Change bone mineral density
timeFrame: Changes from baseline to 8 weeks
measure: Change heart rate
timeFrame: Changes from baseline to 8 weeks
measure: Gait speed change
timeFrame: Changes from baseline to 8 weeks
measure: Time up and go test change
timeFrame: Changes from baseline to 8 weeks
measure: Short physical performance battery (SPPB)
timeFrame: Changes from baseline to 8 weeks
measure: Change in lower limb strenght
timeFrame: Changes from baseline to 8 weeks
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Pablo Jorge Marcos-Pardo
Study officials:
affiliation: Universidad de Almeria
name: Pablo Jorge Marcos-Pardo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCAM
name: Noelia Gonzalez-Galvez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marcos-Pardo PJ, Abelleira-Lamela T, Vaquero-Cristobal R, Gonzalez-Galvez N. Changes in life satisfaction, depression, general health and sleep quality of Spanish older women during COVID-19 lockdown and their relationship with lifestyle: an observational follow-up study. BMJ Open. 2022 Aug 24;12(8):e061993. doi: 10.1136/bmjopen-2022-061993.