NCT02375594

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 2, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

March 2, 2015

Status Verified

February 1, 2015

Enrollment Period

9 months

First QC Date

February 9, 2015

Last Update Submit

February 24, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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)

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"

    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

    3 months (e.g. at 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

    3 months (e.g. at end of intervention)

  • +5 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

Exercise in park equipment

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CAP Vallcarca-Sant Gervasi

Barcelona, Spain

RECRUITING

Fundació Salut i Envelliment

Barcelona, Spain

RECRUITING

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Antoni Salvà, MD

    Fundació Salut i Envelliment

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2015

First Posted

March 2, 2015

Study Start

December 1, 2014

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

March 2, 2015

Record last verified: 2015-02

Locations