Clinical trial NCT02375594: Exercise Park Equipment for Improving Physical Function and Physical Activity Levels in the Elderly
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sedentary Lifestyle
Lead sponsor: Fundacio Salut i Envelliment UAB
Sponsor class: OTHER
Collaborators: name: Lappset Group Oy, España
name: Institut Investigacio Sanitaria Pere Virgili
name: Atenció Primària Vallcarca - Sant Gervasi
First posted: 2015-03-02
Enrollment: 88
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Physical performance measured with the Short Physical Performance Battery
timeFrame: 6 months (3 months follow up after end of intervention)
measure: Amount of moderate or intense physical activity assessed with the International Physical Activity Questionnaire
timeFrame: 6 months (3 months follow up after end of intervention)
Secondary outcomes:
measure: 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"
timeFrame: 6 months (3 months follow up after end of intervention)
measure: Fatigability measured with the Pittsburgh Fatigability Scale for Older Adults
timeFrame: 6 months (3 months follow up after end of intervention)
measure: Fatigability measured with the Pittsburgh Fatigability Scale for Older Adults
timeFrame: 3 months (e.g. at end of intervention)
measure: Functionality measured with the Late Life Function and Disability test
timeFrame: 6 months (3 months follow up after end of intervention)
measure: Functionality measured with the Late Life Function and Disability test
timeFrame: 3 months (e.g. at end of intervention)
measure: Social participation measured with the Index of Subjective Social Participation
timeFrame: 6 months (3 months follow up after end of intervention)
measure: Quality of life measured with SF-12
timeFrame: 6 months (3 months follow up after end of intervention)
measure: Amount of moderate or intense physical activity assessed with the International Physical Activity Questionnaire
timeFrame: 3 months (e.g. at end of intervention)
measure: Physical performance measured with the Short Physical Performance Battery
timeFrame: 3 months (e.g. at end of intervention)
measure: Satisfaction assessed through open-ended questions
timeFrame: 3 months (e.g. at end of intervention)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: CAP Vallcarca-Sant Gervasi
city: Barcelona
country: Spain
facility: Fundació Salut i Envelliment
Study officials:
affiliation: Fundació Salut i Envelliment
name: Antoni Salvà, MD
role: PRINCIPAL_INVESTIGATOR
References: