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Completed

NCT Number: NCT03446352

Multimodal Exercise Programs for Fall Prevention: A Randomized Controlled Trial

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.

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Key information

Conditions

Fallers High Risk of Falling

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade de Évora

Evora, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Psychomotor exercise program

Other

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.

Combined exercise program

Other

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Évora

Other

Collaborators

  • Horizon 2020 - Portugal 2020 (ALT20-03-0145-FEDER-000007 - Project: ESACA)
  • São João de Deus School of Nursing

Registry information

Official study title

Multimodal Exercise Programs for Fall Prevention - Psychomotor Versus Psychomotor Combined With Whole-Body Vibration: A Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Feb 26, 2018
Registry last updated
Dec 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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