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Multimodal Exercise Programs for Fall Prevention: A Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT03446352
Recruitment Status : Completed
First Posted : February 26, 2018
Last Update Posted : December 16, 2021
Sponsor:
Collaborators:
São João de Deus School of Nursing
Horizon 2020 - Portugal 2020 (ALT20-03-0145-FEDER-000007 - Project: ESACA)
Information provided by (Responsible Party):
Hugo Filipe Zurzica Rosado, University of Évora

Brief Summary:

The aim of present study is to analyze and compare the effect of two exercise programs - psychomotor exercise program vs exercise combined program (psychomotor + whole body vibration) - on risk factors for falls of community-dwelling older adults who are fallers or are "at high risk of falling".

This experimental study is a randomized controlled trial. The program will run for 24 weeks (3 sessions / week of 75 minutes), followed by 12 weeks of follow-up without intervention. Participants of the groups will be assessed 1) at baseline, 2) at 12 weeks, 3) at 24 weeks, and 4) after the follow-up. Participants will be randomly allocated to three groups: experimental group 1 (psychomotor program); experimental group 2 (combined program) and control group.


Condition or disease Intervention/treatment Phase
Fallers High Risk of Falling Other: Psychomotor exercise program Other: Combined exercise program Not Applicable

Detailed Description:

Aging is associated with a decline in executive functions, negatively influencing the motor, social and emotional capacities of older adults. (1) These losses will contribute to increase the risk of falling, so much that most falls occur during the performance of a dual-task (DT) (2).

The lack of balance, strength and poor body composition are seen as causes of falls, and should therefore be considered in the prevention programs of these events in older adults. (3-5) A psychomotor exercise program uses the body and movement as mediators, relying on the prevention of cognitive, sensory, perceptive, emotional and affective deterioration, exploring the neuroplasticity. (6,7) Therefore, this sensorimotor and neurocognitive program may prevent falls, but it is important to analyze its real impact in reducing either falls or the risk factors for falls in the older adults. No studies focusing on this subject were found.

The intervention through the whole body vibration (WBV) is referred in the literature as promoting the improvement of balance, mobility and agility, and preventing falls in the older adults.(8,9) WBV will have long-term therapeutic effects promoting the increase of muscle strength and increased bone mineral density. (10) Being two intervention methods with potential good results on falls prevention, it is not known whether there will be additional benefits in an intervention that combines both methods.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Multimodal Exercise Programs for Fall Prevention - Psychomotor Versus Psychomotor Combined With Whole-Body Vibration: A Randomized Controlled Trial
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Psychomotor exercise program
The experimental group 1 (EG1) intervention comprises a psychomotor program. The program integrates 3 sessions / week of 75 minutes on alternated days. The psychomotor intervention includes exercises promoting simultaneous motor and cognitive stimulation (interval training).
Other: Psychomotor exercise program

Each session includes: beginning ritual (5 min), warm-up (15 min), main section comprising the multimodal exercises (40 min), cool-down (10 min), and finishing ritual (5 min).

At the initial stage, the activation of different muscle groups will be performed, providing an elevation of the neurophysiological parameters. The main section (multimodal exercises) will be focused on the specific objectives through sensorimotor and neurocognitive activities. This section includes periods ranging 10-15 min of exercises mainly focused on motor stimulation- physical performance (cardiovascular, strength, balance, flexibility, agility and movement accuracy)- alternating with exercises mainly focused on cognitive stimulation- executive functions (planning ability, information processing speed, attention and dual-task performance).

At the cool-down the participants will normalize their physiological parameters. Finally, at the finishing ritual the participants share their sensations experienced.


Experimental: Combined exercise program
The experimental group 2 (EG2) intervention combines the psychomotor program with a WBV program. The program integrates 3 sessions / week of 75 minutes (including the 6 minutes of WBV) on alternated days.
Other: Combined exercise program

The EG2 intervention combines the psychomotor exercise program with a WBV program. The program integrates 3 sessions / week of 75 minutes (including the 6 minutes of WBV) on alternated days.

The WBV will integrate 3 sessions / week of 6 minutes each, with programed increased exercise time, series, and frequencies throughout the intervention.


No Intervention: Control Group
Usual care. After the study, control group (CG) participants will be offered the opportunity to integrate a similar fall prevention program.



Primary Outcome Measures :
  1. Change from Baseline, between and within groups comparison, in Executive Function [ Time Frame: 0,3,6,9 months ]
    Outcome Measure - Trial Making Test (Part A and B) to assess information processing speed

  2. Change from Baseline, between and within groups comparison, in Executive Function [ Time Frame: 0,3,6,9 months ]
    Outcome Measure - Deary-Liewald Reaction Timed task to assess single and dual-task performance

  3. Change from Baseline, between and within groups comparison, in Executive Function [ Time Frame: 0,3,6,9 months ]
    Outcome Measure - Timed Up and Go (dual-task version) to assess dual-task performance

  4. Change from Baseline, between and within groups comparison, in Executive Function [ Time Frame: 0,3,6,9 months ]
    Outcome Measure - The d2 Test of Attention to assess attention

  5. Change from Baseline, between and within groups comparison, in Physical Performance [ Time Frame: 0,3,6,9 months ]
    Outcome Measure - Biodex (Peak Torque) to assess lower-body strength

  6. Change from Baseline, between and within groups comparison, in Physical Performance [ Time Frame: 0,3,6,9 months ]
    Outcome Measure - Senior Fitness Test (30-s Chair Stand Test) to assess lower-body strength

  7. Change from Baseline, between and within groups comparison, in Physical Performance [ Time Frame: 0,3,6,9 months ]
    Outcome Measure - Timed Up and Go (single and dual-task version) to assess agility

  8. Change from Baseline, between and within groups comparison, in Physical Performance [ Time Frame: 0,3,6,9 months ]
    Outcome Measure - Static Posturography Platform to assess balance

  9. Change from Baseline, between and within groups comparison, in Physical Performance [ Time Frame: 0,3,6,9 months ]
    Outcome Measure - Fullerton Advanced Balance Scale, ranging from 0 (worst) to 40 (best) points, to assess balance

  10. Change from Baseline, between and within groups comparison, in Body Composition [ Time Frame: 0,3,6,9 months ]
    Outcome Measure - Dual-energy X-ray Absorptiometry to assess body fat mass (%) and body lean mass (%)

  11. Change from Baseline, between and within groups comparison, in Body Composition [ Time Frame: 0,3,6,9 months ]
    Outcome Measure - Dual-energy X-ray Absorptiometry to assess bone mineral density

  12. Fall occurrence in the previous 6 months at baseline and at post-intervention [ Time Frame: 0,6 months ]
    Comparasion of the number of falls between and within groups


Secondary Outcome Measures :
  1. Borg Rating of Perceived Exertion [ Time Frame: 0-6 months ]
    Exercise intensity

  2. Mini-Mental State Examination [ Time Frame: 0 months ]
    Cognitive state

  3. Composite Physical Function scale [ Time Frame: 0 months ]
    Physical independence

  4. International Physical Activity Questionnaire [ Time Frame: 0 months ]
    Physical activity



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female participants aged ≥65 years;
  • Community-dwelling older adults;
  • Older adults who have fallen in the last 6 months or who are at high risk of falling (scoring ≤25 points on Fullerton Advanced Balance Scale);
  • Participation agreement;

Exclusion Criteria:

  • Presence of severe cognitive decline (patients with a Mini-Mental State Examination ≤9);
  • Fracture in one or both lower limbs for less than 4 months;
  • Diagnosed of health conditions compromising the program participation, such as: severe osteoporosis (T ≤ 2.5, with the occurrence of one or more associated osteoporotic fractures); hip or knee prostheses; incapacitating cardiovascular conditions; epilepsy; cancer or metastases;
  • Do not wish to participate in the study;

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): NCT03446352


Locations
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Portugal
Universidade de Évora
Évora, Portugal
Sponsors and Collaborators
University of Évora
São João de Deus School of Nursing
Horizon 2020 - Portugal 2020 (ALT20-03-0145-FEDER-000007 - Project: ESACA)
Publications:
World Health Organization. Falls. [online]. 2016; Avaliable at: http://www.who.int/mediacentre/factsheets/fs344/en/
Oliveira V, Carvalho S, Cardoso T. (2015). Quando o envelhecimento acontece. Rio de Janeiro: Wak Editora. Atualidades da Prática Psicomotora. 2015; 217-233.
Fernandes, J. A Gerontopsicomotricidade como Práxis Terapêutica de Mediação Corporal. Journal of Aging and Innovation. 2014; 3 (3).

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hugo Filipe Zurzica Rosado, MSc, University of Évora
ClinicalTrials.gov Identifier: NCT03446352    
Other Study ID Numbers: UEvora
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: December 16, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hugo Filipe Zurzica Rosado, University of Évora:
Falls
Elderly
Psychomotor exercise program
Whole body vibration