Multi-modal Exercise Program in Older Adults (MME-CDOA)

February 5, 2020 updated by: Juan F. Lisón Párraga, Dr, Cardenal Herrera University

Effects of a Multi-modal Exercise Program in Community-dwelling Older Adults

Aim: To evaluate the short-term effects of a multi-modal exercise program on physical performance variables in older adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • Aim: To evaluate the short-term effects of a 16 weeks home-based multi-modal exercise program on physical performance variables in community-dwelling older adults.
  • Design: randomized controlled trial.
  • Setting: home-based intervention.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Valencia
      • Moncada, Valencia, Spain, 46113
        • Universidad CEU Cardenal Herrera

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 65 years
  • Community-dwelling

Exclusion Criteria:

  • Unable to ambulate independently
  • Mini-mental state examination score < 24
  • Barthel Index score < 80
  • Unstable cardiovascular disease
  • Neurological disorder that could compromise exercising
  • Upper or lower-extremity fracture in the past year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
No intervention
Experimental: Experimental-Multi-modal exercise program

Each home-based session (48) starts with 7 minutes of moderate warm-up exercises focusing on mobility and flexibility. Secondly, the strengthening exercises consist of knee extensions, knee flexions, hip abductions, ankle plantar flexions, and ankle dorsiflexions. Thirdly, a set of balance exercises including knee bends, backwards walking, walking and turning around, sideways walking, tandem stance, tandem walk, one leg stand, heel walking, toe walking, toe to heel walking backwards, sit-to-stand, and stair walking.

Finally, participants are instructed to walk at their usual pace for at least 10 minutes.
Other: Experimental-Multi-modal exercise program

Each home-based session (48) starts with 7 minutes of moderate warm-up exercises focusing on mobility and flexibility. Secondly, the strengthening exercises consist of knee extensions, knee flexions, hip abductions, ankle plantar flexions, and ankle dorsiflexions. Thirdly, a set of balance exercises including knee bends, backwards walking, walking and turning around, sideways walking, tandem stance, tandem walk, one leg stand, heel walking, toe walking, toe to heel walking backwards, sit-to-stand, and stair walking.

Finally, participants are instructed to walk at their usual pace for at least 10 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed 'Up-and-Go' test (TUG)
Time Frame: 16 weeks
The participants are instructed to stand up from a standard chair of 45 cm height, walk 3 metre, turn around a cone, return to the chair, and sit down again in the shortest time possible without running. Two trials are performed, and the quicker time in seconds is recorded. Shorter time indicates better performance.
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Repeated chair stand test (STS-5)
Time Frame: 16 weeks
The participants are instructed to stand from a chair five successive times as quickly as possible without the assistance of their arms. Shorter time indicates better performance.
16 weeks
One-Leg Stand test (OLS)
Time Frame: 16 weeks
Participants are instructed to start the test from a standing position with their eyes open and arms at their sides, choose a leg to stand on, flex the opposite knee, allowing the foot to clear the ground, and stand unassisted on one leg as long as possible. Longer time indicates better performance.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardenal Herrera University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2019

Primary Completion (Actual)

December 28, 2019

Study Completion (Actual)

January 10, 2020

Study Registration Dates

First Submitted

May 14, 2019

First Submitted That Met QC Criteria

May 14, 2019

First Posted (Actual)

May 15, 2019

Study Record Updates

Last Update Posted (Actual)

February 6, 2020

Last Update Submitted That Met QC Criteria

February 5, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • UNIVERSITY CARDENAL HERRERA-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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