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Completed

NCT Number: NCT04885608

PReGe 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.

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Key information

Conditions

Frail Elderly

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Salamanca

Salamanca, 37007, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PReGe

Other

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.

Primary outcomes

  1. Short Physical Performance Battery (SPPB)

    Time frame: 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. 2 minute stair test

    Time frame: 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.

  3. Borg Rating of Perceived Exertion Scale

    Time frame: 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.

  4. IPAQ-E Questionnaire

    Time frame: 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 outcomes

  1. Sex

    Time frame: Baseline

    Participant's sex will be registered.

  2. Date of birth

    Time frame: Baseline

    Participant's date of birth will be recorded in order to calculate their age.

  3. Medication

    Time frame: Baseline

    Information on the medication that each participant is currently taking will be collected to evaluate possible interferences.

Sponsors and collaborators

Lead sponsor

University of Salamanca

Other

Collaborators

  • Excelentísimo Ayuntamiento de Salamanca

Registry information

Official study title

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

Acronym: PReGe-BIO

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 13, 2021
Registry last updated
Nov 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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