Effect of lower limb muscle focused vibration, balance platform exercises and treadmill exercises on selected fall risk factors in people aged 65+
| ISRCTN | ISRCTN43613446 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43613446 |
| Secondary identifying numbers | European Regional Development Fund for the Lesser Poland Voivodeship Poland no. RPMP.01.02.02-12-0144/19-00 |
- Submission date
- 17/11/2024
- Registration date
- 30/12/2024
- Last edited
- 30/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
In recent years, the number of people aged over 60 years has been growing rapidly worldwide, and this increase is incomparable to any other age group. The life expectancy of seniors is increasing due to the development of pro-health prevention, advances in medicine and rehabilitation, greater access to medical services and improved personal hygiene of the elderly. However, longer life is not always associated with good health and good quality of life for seniors. It is believed that in the coming years, the incidence of infectious diseases will significantly decrease worldwide, but the number of neuropsychiatric diseases and non-communicable chronic diseases will increase. Degenerative changes that occur with age in the nervous system, sense organs, and the motor apparatus result in impairment of functions responsible for postural control and motor coordination, which increases the risk of falls and injuries in the elderly. In the elderly, falls often result in injuries that become the cause of disability or even death. Most falls by the elderly are multi-causal and are the result of the co-occurrence of involutional changes in the body, pathologies accompanying diseases, multi-drug therapy and environmental factors related to lifestyle and living conditions. The results of the clinical studies confirm that physical exercises reduce the risk of falls in seniors. In randomly allocated medical trials the improvement of body balance and gait quality, as well as the reduction of the risk of falls in seniors were achieved using various types of physical exercises, including strength and endurance exercises, resistance exercises using elastic bands and multidirectional physical training (moderate intensity) including aerobic, strength, flexibility and balance exercises. Studies should take into account and compare different forms of therapy to develop diversified and attractive exercise programs for seniors at fall risk.
Who can participate?
Patients aged 65 to 89 years old undergoing a 2-week rehabilitation stay
What does the study involve?
Participants will be randomly assigned to one of the four groups: experimental groups involving 1. gait training using a treadmill and physical therapy agents; 2. gait training using the treadmill and balance training using a balance system and physical therapy agents; 3. gait training using the treadmill, lower limb muscle-focused vibration with Vibramoov and physical therapy agents; and, 4. a control group will receive physical therapy agents (massage therapy, thermotherapy) as the only form of therapy.
What are the possible benefits and risks of participating?
It is presumed that the treatment will contribute to reducing selected risk factors of falls in people aged 65+.
The selection and methodology of diagnostics and exercises planned in the study were developed based on the analysis of scientific literature and the knowledge and practical experience of the research team members. No invasive diagnostics were used in the study, and the proposed surveys and functional diagnostics are well-known in clinical practice and commonly used in the elderly. Therefore, the occurrence of potential adverse effects during the study is low. Nevertheless, as a result of the exercises, seniors may experience symptoms of fatigue and intensification of pain symptoms associated with degenerative joint disease. There is also a small risk of injuries or falls, especially during exercises on a mechanical treadmill and a balance platform. However, this risk will be minimal because the study will include seniors who move independently, the treadmill and platform will be equipped with side and front handrails for self-protection, and all exercises will be performed under the supervision of a physiotherapist.
Vibration training carries the risk of exacerbating blood vessel and heart diseases, but this applies primarily to whole-body vibration training performed on vibration platforms. In the case of focused vibration of individual muscle groups, which is planned in the study, this risk is small, and in addition, heart and blood vessel diseases, which are a contraindication to vibration therapy, will be a criterion for exclusion from the study. Some people may experience dizziness, headaches, or nausea during exercises using virtual reality. However, this applies in particular to immersive virtual reality, and the study will use virtual reality without immersion, so the risk of the above symptoms is small.
Possible side effects will be noted and, if necessary, the studies will be modified and discontinued, with appropriate notification to the Bioethics Committee.
Where is the study run from?
Rehabilitation Center ''Marzenie'' in Zakopane (Poland).
When is the study starting and how long is it expected to run for?
May 2024 to March 2025
Who is funding the study?
Rehabilitation Center ''Marzenie'' in Zakopane (Poland).
The study was co-financed by the European Regional Development Fund for the Lesser Poland Voivodeship
Who is the main contact?
Anna Polak, a.polak@awf.katowice.pl
Contact information
Public, Scientific, Principal Investigator
72a Mikolowska Street
Katowice
40-065
Poland
 ORCID ID |
0000-0001-6932-5047 |
|---|---|
| Phone | +48 (0)32 2075129 |
| a.polak@awf.katowice.pl |
Study information
| Study design | Single-center interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | The impact of focused vibration of lower limb muscles, balance platform exercises and virtual reality- based treadmill exercises on selected fall risk factors in people aged 65+. Randomized clinical trial |
| Study objectives | Focused vibration of lower limb muscles, virtual reality-based treadmill exercises, exercises on a balance platform with a stable surface will reduce fear of falling, improve body balance and gait quality in people aged 65+. |
| Ethics approval(s) |
Approved 27/06/2024, Bioethics Commission for Scientific Research at The Jerzy Kukuczka Academy of Physical Education in Katowice (72a Mikolowska Street, Katowcie, 40-065, Poland; +48 (032) 2075352; komisjabioetyczna@awf.katowice.pl), ref: 4-VI/2024 |
| Health condition(s) or problem(s) studied | Exercises for reducing selected risk factors of falls in people aged 65+ |
| Intervention | The method of randomisation is sequentially numbered, opaque sealed envelopes. Participants are randomly assigned to groups based on the group symbol in an opaque and sealed envelope. 120 participants will be randomly assigned to one of the 4 following groups: 1. The first experimental group of patients will receive gait training with the use of Zebris FDM treadmill (Medical GmbH, Germany) and physical therapy agents. 2. The second experimental group of patients will receive gait training with the use of Zebris FDM treadmill (Medical GmbH, Germany) and balance training with the use of Biodex Balance System SD (Biodex Medical Systems Inc., Shirley, NY, USA) and physical therapy agents. 3. The third experimental group of patients will receive gait training with the use of Zebris FDM treadmill (Medical GmbH, Germany) and lower limb muscle-focused vibration with Vibramoov (TechnoConcept, France) and physical therapy agents. 4. The control group will receive physical therapy agents (massage therapy, thermotherapy) as the only form of therapy. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Zebris FDM treadmill (Medical GmbH, Germany), Balance platform Biodex Balance System SD (Biodex Medical Systems Inc., Shirley, NY, USA), Focused vibration Vibramoov (TechnoConcept, France) |
| Primary outcome measure | 1. Dynamic body balance measured using the Time Up and Go Test (TUG), at baseline and after the 2-week rehabilitation period |
| Secondary outcome measures | The following secondary outcome measures are assessed at baseline and after the 2-week rehabilitation period: 1. Fear of fall measured using the Falls Efficacy Scale – International (FES-I) 2. Lower body muscle strength measured using the 30-second Sit-to-Stand Test 3. Static body balance measured using the treadmill walking test (Zebris FDM; Medical GmbH, Germany) 4. Gait measured using the treadmill walking test (Zebris FDM;Medical GmbH, Germany) |
| Overall study start date | 27/05/2024 |
| Completion date | 31/03/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Upper age limit | 89 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | 1. Aged 65 to 89 years old 2. Who provides informed consent to participate in the study 3. Able to move independently 4. Staying on a 2-week rehabilitation stay to treat chronic pain caused by degenerative changes in the lower spine and lower limbs, but who do not have symptoms of acute inflammation accompanying the degenerative disease and whose joint pain intensity does not exceed level 5 on the 10-point vas pain assessment scale 5. Whose score for the assessment of independence in daily activities on the 100-point Barthel scale will be above 20 points 6. Whose score for the assessment of cognitive functions in the mini-mental state examination (MMSE) will be above 23 points 7. Who has a clinical history of at least one fall in the past year 8. Who have an increased fear of falling and a fall anxiety score of at least 17 on the 16-item falls efficacy scale – international (FES-I) |
| Key exclusion criteria | 1. Contraindications to the exercises included in the study, including acute inflammation, osteoporosis, bone fractures and other injuries to the lower limbs and spine in the period less than 1 year before the start of the study 2. Malignant neoplastic diseases during treatment, uncontrolled diabetes, diseases of the blood vessels; and lymphatic vessels, and risk of internal and external bleeding 3. Pain intensity due to degenerative spine and limbs exceeding 5 points on a 10-point VAS scale 4. Body balance and movement disorders resulting from diseases of the nervous system, sense organs and cardiovascular system |
| Date of first enrolment | 01/07/2024 |
| Date of final enrolment | 31/03/2025 |
Locations
Countries of recruitment
- Poland
Study participating centre
Zakopane
34-500
Poland
Sponsor information
Hospital/treatment centre
1 Stara Pardalowka Street
Zakopane
34-500
Poland
| Phone | +48 18 201 57 76 |
|---|---|
| biuro@marzenie-zakopane.pl | |
| Website | https://marzenie-zakopane.pl/ |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Europski Fond za Regionalni Razvoj, Den Europæiske Fond for Regionaludvikling, Europees Fonds voor Regionale Ontwikkeling, Euroopa Regionaalarengu Fond, Fonds Européen de Développement Régional, Europäischer Fonds für regionale Entwicklung, Európai Regionális Fejlesztési Alap, Fondo Europeo di Sviluppo Regionale, Eiropas Reģionālās attīstības fonds, Europos Regionines Pletros Fondas, Europejski Fundusz Rozwoju Regionalnego, Fundo Europeu de Desenvolvimento Regional, Fondul European de Dezvoltare Regională, Európsky Fond Regionálneho Rozvoja, Fondo Europeo de Desarrollo Regional, Европейски фонд за регионално развитие, Evropský fond pro regionální rozvoj, Ευρωπαϊκό Ταμείο Περιφερειακής Ανάπτυξης, Il-Fond Ewropew għall-Iżvilupp Reġjonali, Evropski sklad za regionalni razvoj, Euroopan aluekehitysrahasto, Europeiska regionala utvecklingsfonden, ERDF, FEDER, EFRE, ЕФРР, EFRR, EFRU, ERFi, ΕΤΠΑ, FEDER, FESR, ERAF, ERPF, ERFA, L-FEŻR, EFRO, EFRR, FEDR, ESRR, EAKR, Eruf
No information available
Results and Publications
| Intention to publish date | 30/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication in a scientific journal and a doctoral dissertation. |
| IPD sharing plan | The study protocol, the statistical analysis plan and the trial database will be made available at a later date upon request from a.polak@awf.katowice.pl. - Participant-level data will be available upon request at a later date. - Written consent to participate in the study is obtained from each participant. - All participants' data are stored in a form that protects personal health information and prevents personal identification. - Coded data are collected in paper form and electronic documentation. - There are no ethical or legal restrictions to the study. The study was approved on 27/06/2024 by the Bioethics Commission for Scientific Research at The Jerzy Kukuczka Academy of Physical Education in Katowice (ref no.: 4-VI/2024). |
Editorial Notes
18/11/2024: Study's existence confirmed by the Bioethics Commission for Scientific Research at The Jerzy Kukuczka Academy of Physical Education in Katowice.
