Sedentary LifestyleNCT02375594
Exercise Park Equipment for Improving Physical Function and Physical Activity Levels in the Elderly
A study testing Exercise in park equipment in people with Sedentary Lifestyle, run by Fundacio Salut i Envelliment UAB at 2 sites in Spain.
Trial summary
Exercise park equipments for the elderly are designed taking into account the physical and cognitive capabilities and needs of elderly individuals. These equipments are usually built in public spaces, and may be part of public health initiatives to promote active lifestyles in the elderly. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Exercise in park equipment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 2 sitesSpain
- Study dates
- Dec 2014to Oct 2015
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Individuals aged 70 years or more
- Insufficiently active, defined as a person who does not meet the physical activity recommendations of World Health Organization (30 minutes per day of moderate physical activity (including active leisure and travel), 5 days a week; or 30 minutes per day of vigorous physical activity, 3 days a week).
Who cannot join
- The individual refers not being able to walk 400 meters in 15 minutes or less without having to sit, lean, use a walker or require the assistance of another person.
- Moderate or severe cognitive impairment (MiniMental <19).
- Serious disease that limits physical activity (heart disease, cancer, chronic respiratory disease, joint replacements in the last 12 months, severe limitations of range of motion).
- Serious mental illness that prevents participation.
- Prescription of neuroleptic medication.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
CAP Vallcarca-Sant Gervasi
Barcelona
Esperança Palacios, 932594411
- Recruiting
Fundació Salut i Envelliment
Barcelona
Eva Julià, 934335014
About this study
Official title: Sustained Effect of a 12 Week Guided Exercise Program Conducted in an Exercise Park Equipment in the Physical Function and Physical Activity Levels of Physically Inactive Elderly: Randomized Clinical Trial
Exercise park equipments for the elderly are designed taking into account the physical and cognitive capabilities and needs of elderly individuals. These equipments are usually built in public spaces, and may be part of public health initiatives to promote active lifestyles in the elderly.
Previous research has provided clear evidence on the short-term efficacy of exercise programs in improving physical function and level of physical activity in community-dwelling elderly. The goal of this randomized clinical trial is to assess whether an exercise intervention conducted in an exercise park equipment is able to achieve sustained improvements in physical function and level of physical activity, that are maintained for at least 3 months after the end of the intervention. The target population are community-dwelling elderly that are insufficiently active.
- Conditions
- Sedentary Lifestyle
- Being tested
- Exercise in park equipment
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise in park equipmentOther
| Study group | Role | What they receive |
|---|---|---|
| Exercise in park equipment | Experimental | Participants in the intervention arm will attend a 3-month long program of 2 weekly one-hour exercise sessions in the exercise park equipment, guided by a physical therapist. The sessions will comprise a combination of aerobic, strength, balance and flexibility exercises. Up to 20 participants exercising simultaneously in the equipment under the guidance of an experienced LAPPSET physical therapist. Receives: Other: Exercise in park equipment |
| Control | No intervention | Participants in the control arm will receive usual advice on healthy habits. During the study, they will be offered to attend the talks on healthy living for elderly periodically organised by their primary care centre (CAP Vallcarca - Sant Gervasi). At the end of the study, they will be invited to an exercise session at the exercise park equipment, conducted by the study physical therapist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical performance measured with the Short Physical Performance Battery
Physical performance measured with the Short Physical Performance Battery
Measured: 6 months (3 months follow up after end of intervention)
Amount of moderate or intense physical activity assessed with the International Physical Activity Questionnaire
Self reported weekly minutes of moderate or intense physical activity
Measured: 6 months (3 months follow up after end of intervention)
Secondary outcomes (10)
Amount of physical activity in exercise park equipment assessed with the question "Estimate in minutes the duration of any moderate or intense physical activity that you conducted last week in the exercise park equipment"
Self reported weekly minutes of moderate or intense physical activity conducted in the exercise park equipment
Measured: 6 months (3 months follow up after end of intervention)
Fatigability measured with the Pittsburgh Fatigability Scale for Older Adults
Fatigability measured with the Pittsburgh Fatigability Scale for Older Adults
Measured: 6 months (3 months follow up after end of intervention)
Fatigability measured with the Pittsburgh Fatigability Scale for Older Adults
Fatigability measured with the Pittsburgh Fatigability Scale for Older Adults
Measured: 3 months (e.g. at end of intervention)
Functionality measured with the Late Life Function and Disability test
Functionality measured with the Late Life Function and Disability test
Measured: 6 months (3 months follow up after end of intervention)
Functionality measured with the Late Life Function and Disability test
Functionality measured with the Late Life Function and Disability test
Measured: 3 months (e.g. at end of intervention)
Social participation measured with the Index of Subjective Social Participation
Social participation measured with the Index of Subjective Social Participation
Measured: 6 months (3 months follow up after end of intervention)
Quality of life measured with SF-12
Quality of life measured with SF-12
Measured: 6 months (3 months follow up after end of intervention)
Amount of moderate or intense physical activity assessed with the International Physical Activity Questionnaire
Weekly minutes of moderate or intense physical activity
Measured: 3 months (e.g. at end of intervention)
Physical performance measured with the Short Physical Performance Battery
Physical performance measured with the Short Physical Performance Battery
Measured: 3 months (e.g. at end of intervention)
Satisfaction assessed through open-ended questions
Subjective satisfaction with the intervention
Measured: 3 months (e.g. at end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startDec 2014
- Primary completionSep 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio Salut i Envelliment UAB
- Sponsor type
- University, hospital or other
- Collaborators
- Lappset Group Oy, España, Institut Investigacio Sanitaria Pere Virgili, Atenció Primària Vallcarca - Sant Gervasi
- Responsible party
- Sponsor
- Investigators
- Antoni Salvà, MD, Principal investigator, Fundació Salut i Envelliment
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375594
- Sponsor's protocol ID
- FSIE-LAPP-2014
- Status last verified
- Feb 2015
- First submitted
- 9 Feb 2015
- Last updated
- 2 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustained Effect of a 12 Week Guided Exercise Program Conducted in an Exercise Park Equipment in the Physical Function and Physical Activity Levels of Physically Inactive Elderly: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02375594
- Acronym / sponsor ID
- FSIE-LAPP-2014
- Conditions
- Sedentary Lifestyle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Fundacio Salut i Envelliment UABUniversity, hospital or other
- Collaborators
- Lappset Group Oy, España, Institut Investigacio Sanitaria Pere Virgili, Atenció Primària Vallcarca - Sant Gervasi
- Study start
- Dec 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 2 Mar 2015 (estimated)
- 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.
Exercise park equipments for the elderly are designed taking into account the physical and cognitive capabilities and needs of elderly individuals. These equipments are usually built in public spaces, and may be part of public health initiatives to promote active lifestyles in the elderly.
Previous research has provided clear evidence on the short-term efficacy of exercise programs in improving physical function and level of physical activity in community-dwelling elderly. The goal of this randomized clinical trial is to assess whether an exercise intervention conducted in an exercise park equipment is able to achieve sustained improvements in physical function and level of physical activity, that are maintained for at least 3 months after the end of the intervention. The target population are community-dwelling elderly that are insufficiently active.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise in park equipment | Experimental | Other: Exercise in park equipmentParticipants in the intervention arm will attend a 3-month long program of 2 weekly one-hour exercise sessions in the exercise park equipment, guided by a physical therapist. The sessions will comprise a combination of aerobic, strength, balance and flexibility exercises. Up to 20 participants exercising simultaneously in the equipment under the guidance of an experienced LAPPSET physical therapist. |
| Control | No intervention | –Participants in the control arm will receive usual advice on healthy habits. During the study, they will be offered to attend the talks on healthy living for elderly periodically organised by their primary care centre (CAP Vallcarca - Sant Gervasi). At the end of the study, they will be invited to an exercise session at the exercise park equipment, conducted by the study physical therapist. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Individuals aged 70 years or more
- Insufficiently active, defined as a person who does not meet the physical activity recommendations of World Health Organization (30 minutes per day of moderate physical activity (including active leisure and travel), 5 days a week; or 30 minutes per day of vigorous physical activity, 3 days a week).
Key exclusion criteria (5 listed)
- The individual refers not being able to walk 400 meters in 15 minutes or less without having to sit, lean, use a walker or require the assistance of another person.
- Moderate or severe cognitive impairment (MiniMental <19).
- Serious disease that limits physical activity (heart disease, cancer, chronic respiratory disease, joint replacements in the last 12 months, severe limitations of range of motion).
- Serious mental illness that prevents participation.
- Prescription of neuroleptic medication.
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 |
|---|---|---|
| Exercise in park equipment | Other | Exercise in park equipment |
Primary outcome
Physical performance measured with the Short Physical Performance Battery
Time frame: 6 months (3 months follow up after end of intervention)
Physical performance measured with the Short Physical Performance Battery
Amount of moderate or intense physical activity assessed with the International Physical Activity Questionnaire
Time frame: 6 months (3 months follow up after end of intervention)
Self reported weekly minutes of moderate or intense physical activity
10 secondary outcomes
Amount of physical activity in exercise park equipment assessed with the question "Estimate in minutes the duration of any moderate or intense physical activity that you conducted last week in the exercise park equipment"
Time frame: 6 months (3 months follow up after end of intervention)
Fatigability measured with the Pittsburgh Fatigability Scale for Older Adults
Time frame: 6 months (3 months follow up after end of intervention)
Fatigability measured with the Pittsburgh Fatigability Scale for Older Adults
Time frame: 3 months (e.g. at end of intervention)
Functionality measured with the Late Life Function and Disability test
Time frame: 6 months (3 months follow up after end of intervention)
Functionality measured with the Late Life Function and Disability test
Time frame: 3 months (e.g. at end of intervention)
Social participation measured with the Index of Subjective Social Participation
Time frame: 6 months (3 months follow up after end of intervention)
Quality of life measured with SF-12
Time frame: 6 months (3 months follow up after end of intervention)
Amount of moderate or intense physical activity assessed with the International Physical Activity Questionnaire
Time frame: 3 months (e.g. at end of intervention)
Physical performance measured with the Short Physical Performance Battery
Time frame: 3 months (e.g. at end of intervention)
Satisfaction assessed through open-ended questions
Time frame: 3 months (e.g. at end of intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2015.
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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.
Antoni Salvà, MD principal investigator
Fundació Salut i Envelliment
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in park equipment in people with Sedentary Lifestyle, run by Fundacio Salut i Envelliment UAB at 2 sites 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 2 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: status not confirmed, as of the sponsor's last update on 2 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva Julià (+34 934 335 030, fsie@uab.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical performance measured with the Short Physical Performance Battery (time frame: 6 months (3 months follow up after end of intervention)). The study lists 2 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 2 Mar 2015.