PReGe in Outdoor Fitness Parks (PReGe-BIO)

Therapeutic Exercise for Older Adults: Revitalization and Postural Balance in Outdoor Fitness Parks

Older people have been one of the most affected by the Covid-19 pandemic. Restrictive measures to prevent the spread of the virus have affected the lifestyle of older people, which have reduced their level of physical activity. A sedentary lifestyle has negative health consequences, such as increased frailty and decreased functional capacity. The aim of the study is to apply a program of therapeutic exercise in outdoor fitness parks to prevent the complications of sedentary lifestyle. Community-dwelling older adults belonging will participate in an outdoor program to keep security measures and prevent contagion.

Study Overview

• Status: Completed
• Conditions: Frail Elderly
• Intervention / Treatment: Other: PReGe

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Salamanca, Spain, 37007
    • Universidad de Salamanca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• People over 60 year who decide to participate voluntarily.
• Acceptance of Informed Consent.
• Municipal registration in Salamanca.
• Responsible declaration of good health.
• Absence of symptoms compatible with Covid-19.

Exclusion Criteria:

• Presence of absolute or relative contraindications to physical exercise.
• Presence of serious balance limitations, such as severe neurological, visual or musculoskeletal disorders.
• Presence of difficulties to carry out the tests of the Initial Assessment.
• Participate in another physical activity program.
• Incidents or pathologies suffered during the intervention that interfere with the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: PReGe; Group that will perform the intervention with therapeutic exercise.

Other: PReGe; There will be two weekly sessions of 45 minutes, outdoors in outdoor fitness parks. The components of balance, gait, resistance, strength and elasticity will be worked on and breathing exercises will be performed. The sessions will be guided and dosed by physiotherapists, considering the level of perception of effort. Indications will be given to carry out other sessions of 60 to 120 minutes of therapeutic walking (minimum speed of 4 km/hour) during the week, to complete the 150-300 minutes per week of physical activity recommended by the WHO.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Physical Performance Battery (SPPB)	A validated test to identify frail older adults. The score ranges from 0 to 12 points. The lowest scores are for people with the highest degree of frailty.	Change from baseline to 16 weeks follow-up.
2 minute stair test	Test that evaluates cardiorespiratory endurance. There are reference tables that provide a percentile of resistance based on the age and gender of the participant.	Change from baseline to 16 weeks follow-up.
Borg Rating of Perceived Exertion Scale	Exertion rating based on a 6 to 20 rating scale may provide a fairly good estimate of the actual heart rate during physical activity. Higher scores imply a greater degree of perceived exertion.	Change from baseline to 16 weeks follow-up.
IPAQ-E Questionnaire	Questionnaire that evaluates the level of physical activity. The time spent on activities of different intensity during the last 7 days is recorded. The score is calculated in METs-minute-week (MMW). METs refer to a metabolic expenditure rate. A greater number of MMW, greater amount of physical activity is done weekly.	Change from baseline to 16 weeks follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sex	Participant's sex will be registered.	Baseline
Date of birth	Participant's date of birth will be recorded in order to calculate their age.	Baseline
Medication	Information on the medication that each participant is currently taking will be collected to evaluate possible interferences.	Baseline

Collaborators and Investigators

• Sponsor: University of Salamanca
• Collaborators: Excelentísimo Ayuntamiento de Salamanca
• Investigators: Principal Investigator: Fausto J Barbero-Iglesias, PhD, University of Salamanca

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Actual): August 27, 2021
• Study Completion (Actual): August 27, 2021

Study Registration Dates

• First Submitted: May 8, 2021
• First Submitted That Met QC Criteria: May 12, 2021
• First Posted (Actual): May 13, 2021

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Functional capacity; Therapeutic exercise; Fraility; Postural balance
• Other Study ID Numbers: PReGeUSAL-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No