Condition category
Not Applicable
Date applied
13/08/2020
Date assigned
17/08/2020
Last edited
17/08/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Early recognition of elderly people at risk of falling, their needs for appropriate personal-aids, and the provision of ergonomic solutions for arranging their home-environment, are part of the ongoing effort of clinicians to contribute in preventing falls. At the same time, in order to enhance their physical activity, elderly people are recommended exercise programs that usually require an initial relatively-good activity level, or the transfer of the elderly to specialized centers or facilities. These circumstances may pose certain difficulties since they require the individual’s safety and compliance.

Updated data on the control of movement and the brain's ability to change and respond suggest that in certain areas of the brain changes in connections occur in relation to specialized practice: the repeated practice of an activity that is part of a functional task. The adult brain still has the ability to react to functional challenges, whilst inactivity leads to impaired cognitive function and increased reaction time.

This study involves the creation and evaluation of how applicable and effective a home-based program of motor control exercises of the lower extremities would be. The program is designed for a specific desired functional result, combined with individualized preventive ergonomic safety interventions, in frail ambulatory elderly (FAE) people. Additionally, the overall participants’ compliance, the correlation of the extracted results with factors relating to clinical characteristics, functional capacity and health-status, the recording of new falls, and the fear of falling, will also be measured.

Given the above, the aim of this research is to develop and evaluate a combined intervention of motor control exercises and ergonomic arrangement of the home environment in order to reduce falls in FAE.

Who can participate?
Adults aged 65 and above

What does the study involve?
This study involves:
1. The creation of an evidence-based intervention program of movement control exercises of the lower extremities, appropriately designed for FAE
2. Personalized evaluation and changes in matters of safe behavior, clothing and footwear risk
3. The ergonomic evaluation of the residence of the elderly and ergonomic changes where needed
4. Checking the effectiveness of this combined program through this study
5. The comparison of outcomes of the program between the populations of Attica and Achaia

Participants will be randomly allocated to one of two groups, either receiving the individual home-based exercise program for movement control of the legs and home modification, or usual care only. Participants will be complete assessments at the start of the 12-week exercise program, immediately after and at 12 weeks after the exercise program has finished.

What are the possible benefits and risks of participating?
A key expected benefit is a reduction of the fall incidences and/or their severity, as well as an improvement in the functionality and quality-of-life of the FAE within their home environment. It is also expected that there will be a decrease in fear of falling and improved motor control, the reduction of reaction time by practicing specific functional activities, and transfer of this effect to daily-life activities. Also, adjustable lifestyle and environmental factors are expected to be easily identified, increasing the benefits for primary and secondary health care systems.

There are no notable risks of participating. Participation in the study is voluntary. Participants can refuse to participate or stop participating at any time. All information obtained for this study will be used for research purposes only and will be kept strictly confidential.

Where is the study run from?
1. Physiotherapy Department of the University of West Attica (Greece)
2. Physiotherapy Department of the University of Patras (Greece)

When is the study starting and how long is it expected to run for?
From February 2020 to July 2021

Who is funding the study?
European Social Fund, Programme Support of researchers with emphasis on young researchers – 2nd Phase (Grants 2019) of the program ESPA 2014-2020, Ε.P. Developing Human Resources, Education and Lifelong Learning 2014-2020 (Greece)

Who is the main contact?
Tsekoura Maria
mariatsekoura@upatras.gr

Trial website

Contact information

Type

Scientific

Primary contact

Dr Maria Tsekoura

ORCID ID

http://orcid.org/0000-0003-2649-0522

Contact details

Psaron 6
Aigio
25100
Greece
+30 26910 61150
mariatsekour@upatras.gr

Type

Scientific

Additional contact

Dr Sophia Stasi

ORCID ID

https://orcid.org/0000-0002-4238-2700

Contact details

30 Ouranias Street
Irakleio
Attica
12243
Greece
+30 (0)6937052737
stasi@uniwa.gr

Type

Public

Additional contact

Prof John Gliatis

ORCID ID

http://orcid.org/0000-0002-1216-354X

Contact details

Rio Campus
Patras
22564
Greece
+30 6972260536
igliat@upatras.gr

Type

Public

Additional contact

Prof Vassiliki Sakellari

ORCID ID

http://orcid.org/0000-0002-9481-996X

Contact details

Aigaleo
Athens
12243
Greece
+30 6979033952
vsakellari@uniwa.gr

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

80790

Study information

Scientific title

The effect of the implementation of a combined motor control and ergonomic safety-improvement home-based program in the reduction of falls in ambulatory frail elderly

Acronym

McHeELP

Study hypothesis

To investigate if a motor control exercise programme could increase functionality and reduce falls

Ethics approval

Approved 19/02/2020, the University of Patras (University Campus
26504 Rio Achaia, Greece; +30 2610 997841; rescom@upatras.gr), ref: 9807/05/02/2020

Study design

Multicenter randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Prevention of falls in community-dwelling older adults

Intervention

After the baseline assessment, participants will be randomly assigned to one of two groups, group A or B. A quasi-random method, with a 1:1 allocation ratio, will be used for randomization, namely the first selected patient will be assigned to the intervention group, the second to the control group, and so forth. The randomization procedure will be performed by an independent clinician and the participants will be blinded to group allocation. Group A will receive the 12-week individual home-based exercise program for motor control of the lower extremities and individually assessed ergonomic home modification. Group B will receive usual care only.

Participants will be assessed before the 12-week exercise program, immediately after and at 12 weeks after the exercise program has finished.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Function will be assessed using the Timed Up and Go Test at baseline, 12, and 24 weeks
2. Gait speed will be assessed using the 4-m test at baseline, 12, and 24 weeks
3. Fear of falling will be assessed using the Falls Efficacy Scale International (FES-I) questionnaire at baseline, 12, and 24 weeks

Secondary outcome measures

1. Quality of life will be evaluated using the Greek version of the EQ-5D questionnaire at baseline, 12, and 24 weeks
2. Depression and anxiety will be assessed using the Hospital Anxiety and Depression Scale (HADS) at baseline, 12, and 24 weeks
3. Balance will be assessed with the Tandem test and Functional Reach test at baseline, 12, and 24 weeks
4. Physical activity will be assessed with the international physical activity questionnaire (IPAQ) questionnaire at baseline
5. Ability to perform everyday tasks will be assessed using the Lower Extremity Functional Scale (LEFS) questionnaire at baseline, 12, and 24 weeks
6. Proprioception will be assessed using the Lord test and Foot taping test at baseline, 12, and 24 weeks
7. Muscle strength for lower limbs will be assessed using the sit to stand test (30seconds) at baseline, 12, and 24 weeks
8. The active range of the knee and ankle flexion motion and the extension motion will be measured at baseline
9. Coordination will be assessed using the heel-to-shin test at baseline, 12, and 24 weeks
10. Mental state is assessed with the Clock Drawing Task, CDT (Mini – Coq) at baseline
11. Home environment will be assessed using the home falls and accidents screening tool (HOMEFAST) questionnaire at baseline, 12, and 24 weeks
12. Adherence to prescribed home exercise will be assessed via Exercise Adherence Rating Scale (EARS) at 12 weeks
13. Shoe type will be assessed using the Footwear Assessment Tool at baseline, 12, and 24 weeks
14. Baseline data and demographic characteristics will be measured prior to study recruitment

Overall trial start date

01/02/2020

Overall trial end date

01/07/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged >65 years
2. Willing to be assigned to any of the two study intervention groups

Participant type

Other

Age group

Senior

Gender

Both

Target number of participants

65

Participant exclusion criteria

1. Cognitive impairments
2. Neurological disorders
3. Cardiovascular diseases or high blood pressure not controlled with medication
5. Surgery on lower limbs affecting gait within the previous 6 months
6. Medical or other musculoskeletal problems that could affect the ability to complete objective assessments, or exercise with safety
7. Engaged in exercise training currently or within the previous 3 months

Recruitment start date

01/09/2020

Recruitment end date

01/04/2021

Locations

Countries of recruitment

Greece

Trial participating centre

University of Western Attica
Egaleo
Athens
12243
Greece

Trial participating centre

University of Patras
Rio campus, Achaia
Patras
26504
Greece

Sponsor information

Organisation

University of West Attica

Sponsor details

Ag. Spiridonos
Campus Alsos Aigaleo
Aigaleo
European Social Fund ESPA 2014-2020 Developing Human Resources
Education and Lifelong Learning
Athens
12243
Greece
+30 2105385100
elke@uniwa.gr

Sponsor type

University/education

Website

https://elke.uniwa.gr/

Funders

Funder type

Government

Funder name

European Social Fund

Alternative name(s)

Fondo Sociale Europeo, Fondo Social Europeo, Fonds Social Européen, Europäische Sozialfonds, ESF

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high impact peer-reviewed journal

IPD sharing statement:
The datasets generated during and/or analyzed during the current study will be stored in a non publically available repository. Access is only available to the corresponding author (Dr. Maria Tsekoura) and the 3 additional researchers (Dr. Stasi S., Prof. Sakellari V., Prof. Gliatis J.). During recruitment, participants will be informed of the purposes of the study. Participants will agree to participate and will sign an informed consent form. Names of participants on the datasets will be replaced with codes, ensuring anonymisation (not applicable via weblink). Individual participant data collected during the trial will be available after de-identification (text, tables, figures, and appendices), beginning 9 months and ending 36 months following article publication. Access will be granted to researchers who provide a methodologically sound proposal, in order for them to achieve the aims in the approved proposal. Proposals should be directed to mariatsekour@upatras.gr. To gain access, data requestors will need to sign a data access agreement. After 36 months the data will not be applicable.

Intention to publish date

01/07/2022

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

17/08/2020: Trial’s existence confirmed by the University of Patras .