NCT04885608

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

May 10, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2021

Completed
Last Updated

November 11, 2021

Status Verified

November 1, 2021

Enrollment Period

4 months

First QC Date

May 8, 2021

Last Update Submit

November 3, 2021

Conditions

Frail Elderly

Keywords

Therapeutic exerciseFrailityFunctional capacityPostural balance

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • Sex

    Baseline

  • Date of birth

    Baseline

  • Medication

    Baseline

Study Arms (1)

PReGe

EXPERIMENTAL

Group that will perform the intervention with therapeutic exercise.

Other: PReGe

Interventions

PReGeOTHER

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.

PReGe

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Salamanca

Salamanca, 37007, Spain

Location

Study Officials

  • Fausto J Barbero-Iglesias, PhD

    University of Salamanca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean

Study Record Dates

First Submitted

May 8, 2021

First Posted

May 13, 2021

Study Start

May 10, 2021

Primary Completion

August 27, 2021

Study Completion

August 27, 2021

Last Updated

November 11, 2021

Record last verified: 2021-11

Locations

ES(1)