NCT04958499

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
11 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

Same day

First QC Date

June 22, 2021

Last Update Submit

May 7, 2024

Conditions

Keywords

AdultsOlderPhysical activityExerciseBio-healthy parkTraining

Outcome Measures

Primary Outcomes (1)

  • Muscle quality sarcopenia

    Sarcopenia will be assessed taking into account the reference values established for muscle quality. The muscle quality will be measure by hand grip strength test. This test will be performance with manual dynamometry (TKK 5401; Scientific Instruments Co., Ltd., Tokyo, Japan). Maximal isometric upper limb strength will be performance by maximal isometric strength. Upper strength will be register by kilogrammes. Higher value show high strength.

    Changes from baseline to 8 weeks

Secondary Outcomes (15)

  • Change Body composition

    Changes from baseline to 8 weeks

  • Change Blood pressure

    Changes from baseline to 8 weeks

  • Change Chair stand test

    Changes from baseline to 8 weeks

  • Change Upper strength

    Changes from baseline to 8 weeks

  • Change Sagittal spinal curvature

    Changes from baseline to 8 weeks

  • +10 more secondary outcomes

Study Arms (2)

Bio-Healthy Park

EXPERIMENTAL

This group is the experimental group. The intervention program consisted in the realization of the program on bio-healthy machinery.

Behavioral: Bio-healthy Park

Control

NO INTERVENTION

Adults and older assigned to the control group will not received any structured exercise programme. They will maintain their usual physical activities.

Interventions

Experimental group will receive the exercise program on bio-healthy machinery with a frequency of 2 sessions per week of 55 minutes for 8 weeks. Experimental group 1 will perform the intervention program using machinery designed for self-loading use. 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.

Bio-Healthy Park

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pablo Jorge Marcos-Pardo

Murcia, Spain

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Pablo Jorge Marcos-Pardo, PhD

    Universidad de Almeria

    PRINCIPAL INVESTIGATOR
  • Noelia Gonzalez-Galvez, PhD

    UCAM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 22, 2021

First Posted

July 12, 2021

Study Start

June 1, 2022

Primary Completion

June 1, 2022

Study Completion

September 30, 2022

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations