PReGe in Outdoor Fitness Parks

Frail Elderly Clinical Trial

— PReGe-BIO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04885608
• Other study ID #: PReGeUSAL-2021
• Status: Completed
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: August 27, 2021

Study information

• Verified date: November 2021
• Source: University of Salamanca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 27, 2021
• Est. primary completion date: August 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Frail Elderly

Intervention

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.

Locations

Country	Name	City	State
Spain	Universidad de Salamanca	Salamanca

Sponsors (2)

Lead Sponsor	Collaborator
University of Salamanca	Excelentísimo Ayuntamiento de Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

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