Exercise Park Equipment for Improving Physical Function and Physical Activity Levels in the Elderly

Sedentary Lifestyle Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02375594
• Other study ID #: FSIE-LAPP-2014
• Status: Recruiting
• Phase: N/A
• First received: February 9, 2015
• Last updated: February 24, 2015
• Start date: December 2014
• Est. completion date: October 2015

Study information

• Verified date: February 2015
• Source: Fundacio Salut i Envelliment UAB
• Contact: Eva Julià
• Phone: +34 934 335 030
• Email: fsie[@]uab.cat
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 70 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sedentary Lifestyle

Intervention

Other:
• Exercise in park equipment

Locations

Country	Name	City	State
Spain	CAP Vallcarca-Sant Gervasi	Barcelona
Spain	Fundació Salut i Envelliment	Barcelona

Sponsors (4)

Lead Sponsor	Collaborator
Fundacio Salut i Envelliment UAB	Atenció Primària Vallcarca - Sant Gervasi, Institut Investigacio Sanitaria Pere Virgili, Lappset Group Oy, España

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical performance measured with the Short Physical Performance Battery	Physical performance measured with the Short Physical Performance Battery	6 months (3 months follow up after end of intervention)	No
Primary	Amount of moderate or intense physical activity assessed with the International Physical Activity Questionnaire	Self reported weekly minutes of moderate or intense physical activity	6 months (3 months follow up after end of intervention)	No
Secondary	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	6 months (3 months follow up after end of intervention)	No
Secondary	Fatigability measured with the Pittsburgh Fatigability Scale for Older Adults	Fatigability measured with the Pittsburgh Fatigability Scale for Older Adults	6 months (3 months follow up after end of intervention)	No
Secondary	Fatigability measured with the Pittsburgh Fatigability Scale for Older Adults	Fatigability measured with the Pittsburgh Fatigability Scale for Older Adults	3 months (e.g. at end of intervention)	No
Secondary	Functionality measured with the Late Life Function and Disability test	Functionality measured with the Late Life Function and Disability test	6 months (3 months follow up after end of intervention)	No
Secondary	Functionality measured with the Late Life Function and Disability test	Functionality measured with the Late Life Function and Disability test	3 months (e.g. at end of intervention)	No
Secondary	Social participation measured with the Index of Subjective Social Participation	Social participation measured with the Index of Subjective Social Participation	6 months (3 months follow up after end of intervention)	No
Secondary	Quality of life measured with SF-12	Quality of life measured with SF-12	6 months (3 months follow up after end of intervention)	No
Secondary	Amount of moderate or intense physical activity assessed with the International Physical Activity Questionnaire	Weekly minutes of moderate or intense physical activity	3 months (e.g. at end of intervention)	No
Secondary	Physical performance measured with the Short Physical Performance Battery	Physical performance measured with the Short Physical Performance Battery	3 months (e.g. at end of intervention)	No
Secondary	Satisfaction assessed through open-ended questions	Subjective satisfaction with the intervention	3 months (e.g. at end of intervention)	No

External Links

•   Web page of the Clinical Trial Sponsor