Multimodal Exercise Programs for Fall Prevention: A Randomized Controlled Trial

Not Applicable

Completed

• Conditions: High Risk of Falling; Fallers
• Interventions: Other: Psychomotor exercise program; Other: Combined exercise program

• Registration Number: NCT03446352
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-02-07
• Study First Submitted QC: 2018-02-22
• Study First Posted: 2018-02-26
• Primary Completion: 2018-10-30
• Study Completion: 2019-02-28
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-01
• Last Update Posted: 2021-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychomotor exercise program	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).
Combined exercise program	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline, between and within groups comparison, in Executive Function	0,3,6,9 months	Outcome Measure - The d2 Test of Attention to assess attention
Change from Baseline, between and within groups comparison, in Physical Performance	0,3,6,9 months	Outcome Measure - Fullerton Advanced Balance Scale, ranging from 0 (worst) to 40 (best) points, to assess balance
Change from Baseline, between and within groups comparison, in Body Composition	0,3,6,9 months	Outcome Measure - Dual-energy X-ray Absorptiometry to assess bone mineral density
Fall occurrence in the previous 6 months at baseline and at post-intervention	0,6 months	Comparasion of the number of falls between and within groups

Secondary Outcome Measures

Name	Time	Method
Borg Rating of Perceived Exertion	0-6 months	Exercise intensity
Mini-Mental State Examination	0 months	Cognitive state
Composite Physical Function scale	0 months	Physical independence
International Physical Activity Questionnaire	0 months	Physical activity

Trial Locations

Locations (1)

Universidade de Évora; 🇵🇹 Évora, Portugal