Frail ElderlyPReGe-BIONCT04885608
PReGe in Outdoor Fitness Parks
A study testing PReGe in people with Frail Elderly, run by University of Salamanca at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frail Elderly
- What is being tested?
- PReGe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 10 May 2021to 27 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Frail Elderly
- Being tested
- PReGe
- Keywords
- Therapeutic exercise, Fraility, Functional capacity, Postural balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| PReGe | Experimental | Group that will perform the intervention with therapeutic exercise. Receives: Other: PReGe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to 16 weeks follow-up.
Secondary outcomes (3)
Sex
Participant's sex will be registered.
Measured: Baseline
Date of birth
Participant's date of birth will be recorded in order to calculate their age.
Measured: Baseline
Medication
Information on the medication that each participant is currently taking will be collected to evaluate possible interferences.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start10 May 2021
- Primary completion27 Aug 2021
- Study completion27 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Collaborators
- Excelentísimo Ayuntamiento de Salamanca
- Responsible party
- Principal investigator, Fausto Jose Barbero-Iglesias, University of Salamanca
- Investigators
- Fausto J Barbero-Iglesias, PhD, Principal investigator, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885608
- Sponsor's protocol ID
- PReGeUSAL-2021
- Acronym
- PReGe-BIO
- Status last verified
- Nov 2021
- First submitted
- 8 May 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Exercise for Older Adults: Revitalization and Postural Balance in Outdoor Fitness Parks
- ClinicalTrials.gov ID
- NCT04885608
- Acronym / sponsor ID
- PReGe-BIO / PReGeUSAL-2021
- Conditions
- Frail Elderly
- Keywords
- Therapeutic exercise, Fraility, Functional capacity, Postural balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Collaborators
- Excelentísimo Ayuntamiento de Salamanca
- Study start
- 10 May 2021 (actual)
- Primary completion
- 27 Aug 2021 (actual)
- Study completion
- 27 Aug 2021 (actual)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PReGe | Experimental | Other: PReGeGroup that will perform the intervention with therapeutic exercise. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PReGeThere 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. | Other | PReGe |
Primary outcome
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 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.
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.
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.
3 secondary outcomes
Sex
Time frame: Baseline
Date of birth
Time frame: Baseline
Medication
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fausto J Barbero-Iglesias, PhD principal investigator
University of Salamanca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PReGe in people with Frail Elderly, run by University of Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (SPPB) (time frame: Change from baseline to 16 weeks follow-up.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2021.