NCT02836587

Brief Summary

Fall related injuries are major health problem which effect especially elderly population. After experiencing a fall, most of the elderly are unable to resume their previous mobility and the fear of future falls affects their daily life. Falls in elderly population are often related to balance or gait problems. The aim of this study is to assess the influence of balance training on postural and motor control of healthy elderly participants. The study is designed as a parallel interventional study with experimental and control group (allocation ratio 1:1). Participants' general health, balance abilities, fear of falling and gait stability and variability will be assessed on the baseline measurement, right after and 2 months after the completion of the training programme. Experimental group will undergo training focused on development of balance abilities and strength twice a week (60 minutes in length each) for 8 weeks. Participants will receive individualized exercises which will be focused on the main 4 types - stance exercises, gait and transition exercises and strength exercises especially focused on muscle strength of lower extremities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 19, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2017

Completed
Last Updated

September 20, 2017

Status Verified

September 1, 2017

Enrollment Period

11 months

First QC Date

June 7, 2016

Last Update Submit

September 19, 2017

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change from baseline Berg balance scale score after completing intervention

    2 months

  • Change from baseline mean velocity of centre of pressure during quiet stance after completing intervention

    2 months

  • Change from baseline stride time variability after completing intervention

    2 months

Secondary Outcomes (3)

  • Change from baseline Falls efficacy scale - International score after completing intervention

    2 months

  • Change from baseline gait velocity after completing intervention

    2 months

  • Change from baseline short-term Lyapunov exponents after completing intervention

    2 months

Study Arms (2)

interventional

EXPERIMENTAL

Experimental group will undergo balance training for 8 weeks.

Behavioral: Balance training

control

NO INTERVENTION

Control group will have no assigned intervention.

Interventions

The interventional program will last 8 weeks with the intensity of two 60-minutes lectures a week. Training sessions will be delivered by a physiotherapist to small groups of patients (3-5). Participants will receive individualized exercises which will be focused on main 4 types - stance exercises, gait and transition exercises and strength exercises especially focused on muscle strength of the lower extremities. The difficulty level will be increased progressively after participant's ability to complete each exercise independently (e.g. eyes closed, exercises on balance equipment - wobble board, foam etc., addition of a secondary cognitive task). The training session will consist of a ten-minute warm-up followed by five-minute stretching, 30 minutes of balance training and 15 minutes of stretching and relaxation.

interventional

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 60+
  • ability to stand and walk without aid or support
  • participation in the institutional program "Falls risk and balance assessment" with successful completion of one year of observation for falls

You may not qualify if:

  • neuromuscular or orthopaedic impairments that severely limit mobility and balance
  • surgery or injury on the musculoskeletal system less than 2 years before baseline measurement
  • any acute illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Culture, Palacky University Olomouc

Olomouc, 77111, Czechia

Location

Study Officials

  • Zdenek Svoboda, Ph.D.

    Faculty of Physical Culture, Palacky University Olomouc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

June 7, 2016

First Posted

July 19, 2016

Study Start

September 1, 2016

Primary Completion

July 16, 2017

Study Completion

September 19, 2017

Last Updated

September 20, 2017

Record last verified: 2017-09

Locations