PReGe in Outdoor Fitness Parks

Not Applicable

Completed

• Conditions: Frail Elderly
• Interventions: Other: PReGe

• Registration Number: NCT04885608
• Lead Sponsor: University of Salamanca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-08
• Study Start: 2021-05-10
• Study First Submitted QC: 2021-05-12
• Study First Posted: 2021-05-13
• Primary Completion: 2021-08-27
• Study Completion: 2021-08-27
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-03
• Last Update Posted: 2021-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PReGe	PReGe	Group that will perform the intervention with therapeutic exercise.

Primary Outcome Measures

Name	Time	Method
Short Physical Performance Battery (SPPB)	Change from baseline to 16 weeks follow-up.	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.
2 minute stair test	Change from baseline to 16 weeks follow-up.	Test that evaluates cardiorespiratory endurance. There are reference tables that provide a percentile of resistance based on the age and gender of the participant.
Borg Rating of Perceived Exertion Scale	Change from baseline to 16 weeks follow-up.	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.
IPAQ-E Questionnaire	Change from baseline to 16 weeks follow-up.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universidad de Salamanca; 🇪🇸 Salamanca, Spain