- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02375594
Exercise Park Equipment for Improving Physical Function and Physical Activity Levels in the Elderly
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eva Julià
- Phone Number: +34 934 335 030
- Email: fsie@uab.cat
Study Locations
-
-
-
Barcelona, Spain
- Recruiting
- CAP Vallcarca-Sant Gervasi
-
Contact:
- Esperança Palacios
- Phone Number: 932594411
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Barcelona, Spain
- Recruiting
- Fundació Salut i Envelliment
-
Contact:
- Eva Julià
- Phone Number: 934335014
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise in park equipment
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.
|
|
No Intervention: Control
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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: 6 months (3 months follow up after end of intervention)
|
Self reported weekly minutes of moderate or intense physical activity
|
6 months (3 months follow up after end of intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Self reported weekly minutes of moderate or intense physical activity conducted in the exercise park equipment
|
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
|
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)
|
Fatigability measured with the Pittsburgh Fatigability Scale for Older Adults
|
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
|
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)
|
Functionality measured with the Late Life Function and Disability test
|
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)
|
Social participation measured with the Index of Subjective Social Participation
|
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)
|
Quality of life measured with SF-12
|
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)
|
Weekly minutes of moderate or intense physical activity
|
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)
|
Physical performance measured with the Short Physical Performance Battery
|
3 months (e.g. at end of intervention)
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Satisfaction assessed through open-ended questions
Time Frame: 3 months (e.g. at end of intervention)
|
Subjective satisfaction with the intervention
|
3 months (e.g. at end of intervention)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Antoni Salvà, MD, Fundació Salut i Envelliment
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FSIE-LAPP-2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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