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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03951688
Recruitment Status : Completed
First Posted : May 15, 2019
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
Juan F. Lisón Párraga, Dr, Cardenal Herrera University

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

Condition or disease Intervention/treatment Phase
Community-dwelling Older Adults Other: Experimental-Multi-modal exercise program Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Effects of a Multi-modal Exercise Program in Community-dwelling Older Adults
Actual Study Start Date : May 31, 2019
Actual Primary Completion Date : December 28, 2019
Actual Study Completion Date : January 10, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
No Intervention: Control Group
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951688


Locations
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Spain
Universidad CEU Cardenal Herrera
Moncada, Valencia, Spain, 46113
Sponsors and Collaborators
Cardenal Herrera University
Investigators
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Principal Investigator: JF Lisón, PhD Cardenal Herrera University
More Information
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Responsible Party: Juan F. Lisón Párraga, Dr, Head of Medicine, Cardenal Herrera University
ClinicalTrials.gov Identifier: NCT03951688    
Other Study ID Numbers: UNIVERSITY CARDENAL HERRERA-21
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No