Effectiveness of C-Mill Treadmill Training Versus Conventional Treadmill on Balance and Psychological Status in Elderly

Elderly Clinical Trial

Official title:

Effectiveness of C-Mill Treadmill Training Versus Conventional Treadmill on Balance and Psychological Status in Elderly Population: A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05846633
• Other study ID #: IRB-PGS-2023-03-253
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: May 2, 2024

Study information

• Verified date: December 2023
• Source: Imam Abdulrahman Bin Faisal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Aging is characterized by reduced cognitive and physical functions; consequently, balance, falling and different activities of daily living get exaggerated reductions. Psychological status and falling are related bidirectionally. Depression is a common mental or mood disorder affecting more than 264 million people worldwide. It is a recurrent state of unhappiness and loss of interest. It is not simple as fluctuating mood because of short emotional response. To prevent falling, functional mobility and impairment of balance should be addressed. Many studies have shown that treadmill training is effective in improving the elderly person's ability to walk. The C-Mill treadmill afford a safe virtual reality environment and challenging obstacles and balance games, which increase of walking and improve everyday life performance. Aims: This study aims are to investigate the clinical effectiveness of virtual reality treadmill training on psychological status and balance in elderly population in addition to compare the significant differences between them. Materials & Methods: Fifty-Eight elderly participants will be equally and randomly assigned to Group-I: Twenty-Nine participants will be trained on C-Mill treadmill for 50 minutes per session /2 session /week for six successive weeks. Group-II: Twenty-Nine participants will be trained on conventional treadmill for 50 minutes per session /2 session /week for six successive weeks. Psychological status and Depression will be evaluated by using the Depression Anxiety Stress Scale-2, Geriatric Depression Scale and the Beck Depression Inventory while the balance will be evaluated by using Berge balance scale and timed up and go test, whereas the functional capacity will be measured by using 6 MWT. Statistical analysis: The data will be statistically analysis by using (SPSS version 25). The Shapiro walk test will be used to examine the normality of data distribution. Independent t- test will be used to determine significant differences between two groups (between groups) and paired t- test to determine significant differences before and after intervention in both groups. Significance level at <0.05 and confidence interval CI with 95%.

Description:

Fifty-Eight elderly participants will be equally and randomly assigned to Group-I: Twenty-Nine participants will be trained on C-Mill treadmill for 50 minutes per session /2 session /week for six successive weeks. Group-II: Twenty-Nine participants will be trained on conventional treadmill for 50 minutes per session /2 session /week for six successive weeks. Psychological status and Depression will be evaluated by using the Depression Anxiety Stress Scale-2, Geriatric Depression Scale and the Beck Depression Inventory while the balance will be evaluated by using Berge balance scale and timed up and go test, whereas the functional capacity will be measured by using 6 MWT

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: May 2, 2024
• Est. primary completion date: May 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 75 Years

Eligibility

Inclusion Criteria:

• elderly male & female (60-75 years old) subjects will participate in this study. Based on a confirmed written medical report and signed by their physicians. They should be with controlled and stable medical condition, neither Vit-D deficient nor thyroid affected. Participants should have an acceptable level of cognitive function (score 25 or more on Mini-Mental State Examination, score 40 or less on Berg Balance Scale (BBSand score more than 5 on Geriatric Depression Scale (GDS). All participants should not receive other training to improve their balance and gait other than the protocol of this study. Exclusion Criteria:

Participants will be excluded if they have one of the following conditions:

• Medically unstable
• Fxed lower limb bony deformities
• Muscle paralysis,
• Cerebellar impairment,
• Visual problems,
• Vestibular problems,
• Cognitive reduction, any condition may lead to problematic exercises
• Using vertigo or anti-seizures medications,
• Score more than 40 on Berg Balance Scale (BBS)
• Score less than 5 on Geriatric Depression Scale (GDS).

Related Conditions & MeSH terms

• Elderly
• Geriatric

Intervention

Device:
• C mell treadmill
C Mell treadmill provides Virtual Reality environment for rehabilitation with obstacles and motivational assistance

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Imam Abdulrahman Bin Faisal University

References & Publications (42)

Alabdullgader A, Rabbani U. Prevalence and Risk Factors of Falls Among the Elderly in Unaizah City, Saudi Arabia. Sultan Qaboos Univ Med J. 2021 Feb;21(1):e86-e93. doi: 10.18295/squmj.2021.21.01.012. Epub 2021 Mar 15. — View Citation

Alghnam S, Alsayyari AS, Towhari JA, Alsayer RM, Almohaimeed MY, Aldebasi MH, Albabtin IT. Epidemiological characteristics of fall injuries and their related outcome in Riyadh, Saudi Arabia: A descriptive study from a Level-I trauma center. J Family Community Med. 2020 May-Aug;27(2):114-119. doi: 10.4103/jfcm.JFCM_245_19. Epub 2020 Jun 3. — View Citation

Ali AM, Ahmed A, Sharaf A, Kawakami N, Abdeldayem SM, Green J. The Arabic Version of The Depression Anxiety Stress Scale-21: Cumulative scaling and discriminant-validation testing. Asian J Psychiatr. 2017 Dec;30:56-58. doi: 10.1016/j.ajp.2017.07.018. Epub 2017 Jul 18. — View Citation

Almegbel FY, Alotaibi IM, Alhusain FA, Masuadi EM, Al Sulami SL, Aloushan AF, Almuqbil BI. Period prevalence, risk factors and consequent injuries of falling among the Saudi elderly living in Riyadh, Saudi Arabia: a cross-sectional study. BMJ Open. 2018 Jan 10;8(1):e019063. doi: 10.1136/bmjopen-2017-019063. — View Citation

Alshammari SA, Alhassan AM, Aldawsari MA, Bazuhair FO, Alotaibi FK, Aldakhil AA, Abdulfattah FW. Falls among elderly and its relation with their health problems and surrounding environmental factors in Riyadh. J Family Community Med. 2018 Jan-Apr;25(1):29-34. doi: 10.4103/jfcm.JFCM_48_17. — View Citation

Ashworth NL, Chad KE, Harrison EL, Reeder BA, Marshall SC. Home versus center based physical activity programs in older adults. Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD004017. doi: 10.1002/14651858.CD004017.pub2. — View Citation

Beck, A. T., Steer, R. A., & Carbin, M. G. (1988). Psychometric properties of the Beck Depression Inventory: Twenty-five years of evaluation. Clinical psychology review, 8(1), 77-100.

Berg KO, Wood-Dauphinee SL, Williams JI, Maki B. Measuring balance in the elderly: validation of an instrument. Can J Public Health. 1992 Jul-Aug;83 Suppl 2:S7-11. — View Citation

Berger-Vachon, C. (2006). Virtual reality and disability. Technology and Disability, 18(4), 163-165.

Berry, B. D. (2013). Effects of upper body resistance while treadmill walking in older adults (Doctoral dissertation, Wichita State University).

Blazer DG. Depression in late life: review and commentary. J Gerontol A Biol Sci Med Sci. 2003 Mar;58(3):249-65. doi: 10.1093/gerona/58.3.m249. — View Citation

Britton A, Shipley M, Singh-Manoux A, Marmot MG. Successful aging: the contribution of early-life and midlife risk factors. J Am Geriatr Soc. 2008 Jun;56(6):1098-105. doi: 10.1111/j.1532-5415.2008.01740.x. Epub 2008 May 12. — View Citation

Burns ER, Stevens JA, Lee R. The direct costs of fatal and non-fatal falls among older adults - United States. J Safety Res. 2016 Sep;58:99-103. doi: 10.1016/j.jsr.2016.05.001. Epub 2016 May 28. — View Citation

Cabeza, R., Nyberg, L., & Park, D. C. (Eds.). (2016). Cognitive neuroscience of aging: Linking cognitive and cerebral aging. Oxford University Press.

Cachupe, W. J., Shifflett, B., Kahanov, L., & Wughalter, E. H. (2001). Reliability of biodex balance system measures. Measurement in physical education and exercise science, 5(2), 97-108.

Cakit BD, Saracoglu M, Genc H, Erdem HR, Inan L. The effects of incremental speed-dependent treadmill training on postural instability and fear of falling in Parkinson's disease. Clin Rehabil. 2007 Aug;21(8):698-705. doi: 10.1177/0269215507077269. — View Citation

Cesari M, Landi F, Torre S, Onder G, Lattanzio F, Bernabei R. Prevalence and risk factors for falls in an older community-dwelling population. J Gerontol A Biol Sci Med Sci. 2002 Nov;57(11):M722-6. doi: 10.1093/gerona/57.11.m722. — View Citation

Chand SP, Arif H, Kutlenios RM. Depression (Nursing). 2023 Jul 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK568733/ — View Citation

Chen CH, Lin SF, Yu WH, Lin JH, Chen HL, Hsieh CL. Comparison of the test-retest reliability of the balance computerized adaptive test and a computerized posturography instrument in patients with stroke. Arch Phys Med Rehabil. 2014 Aug;95(8):1477-83. doi: 10.1016/j.apmr.2014.03.005. Epub 2014 Mar 21. — View Citation

Cho GH, Hwangbo G, Shin HS. The Effects of Virtual Reality-based Balance Training on Balance of the Elderly. J Phys Ther Sci. 2014 Apr;26(4):615-7. doi: 10.1589/jpts.26.615. Epub 2014 Apr 23. — View Citation

Cobb, S., Brooks, T., Sharkey, P. M., & Merrick, J. (2006). Virtual reality and disability [Editorial]. International Journal on Disability and Human Development, 5(2), 95-96. https://doi.org/10.1515/IJDHD.2006.5.2.95

Crosbie JH, Lennon S, Basford JR, McDonough SM. Virtual reality in stroke rehabilitation: still more virtual than real. Disabil Rehabil. 2007 Jul 30;29(14):1139-46; discussion 1147-52. doi: 10.1080/09638280600960909. — View Citation

Cuijpers P, van Straten A, Smit F. Psychological treatment of late-life depression: a meta-analysis of randomized controlled trials. Int J Geriatr Psychiatry. 2006 Dec;21(12):1139-49. doi: 10.1002/gps.1620. — View Citation

de Rooij, I. J., van de Port, I. G., & Meijer, J. W. G. (2017). Feasibility and effectiveness of virtual reality training on balance and gait recovery early after stroke: a pilot study. Walking in relation to participation after stroke, 129.

Deandrea S, Lucenteforte E, Bravi F, Foschi R, La Vecchia C, Negri E. Risk factors for falls in community-dwelling older people: a systematic review and meta-analysis. Epidemiology. 2010 Sep;21(5):658-68. doi: 10.1097/EDE.0b013e3181e89905. — View Citation

Deshpande N, Metter EJ, Lauretani F, Bandinelli S, Guralnik J, Ferrucci L. Activity restriction induced by fear of falling and objective and subjective measures of physical function: a prospective cohort study. J Am Geriatr Soc. 2008 Apr;56(4):615-20. doi: 10.1111/j.1532-5415.2007.01639.x. Epub 2008 Feb 26. — View Citation

Dockx K, Bekkers EM, Van den Bergh V, Ginis P, Rochester L, Hausdorff JM, Mirelman A, Nieuwboer A. Virtual reality for rehabilitation in Parkinson's disease. Cochrane Database Syst Rev. 2016 Dec 21;12(12):CD010760. doi: 10.1002/14651858.CD010760.pub2. — View Citation

Dusemund F, Steiner M, Vuilliomenet A, Muller C, Bossart R, Regez K, Schild U, Conca A, Huber A, Reutlinger B, Muller B, Albrich WC. Multidisciplinary Assessment to Personalize Length of Stay in Acute Decompensated Heart Failure (OPTIMA II ADHF). J Clin Med Res. 2012 Dec;4(6):402-9. doi: 10.4021/jocmr1154w. Epub 2012 Nov 11. — View Citation

Fokkenrood HJ, Bendermacher BL, Lauret GJ, Willigendael EM, Prins MH, Teijink JA. Supervised exercise therapy versus non-supervised exercise therapy for intermittent claudication. Cochrane Database Syst Rev. 2013 Aug 23;(8):CD005263. doi: 10.1002/14651858.CD005263.pub3. — View Citation

Galea M, Woodward M. Mini-Mental State Examination (MMSE). Aust J Physiother. 2005;51(3):198. doi: 10.1016/s0004-9514(05)70034-9. No abstract available. — View Citation

Gao Z, Lee JE, McDonough DJ, Albers C. Virtual Reality Exercise as a Coping Strategy for Health and Wellness Promotion in Older Adults during the COVID-19 Pandemic. J Clin Med. 2020 Jun 25;9(6):1986. doi: 10.3390/jcm9061986. — View Citation

Gaugler JE, Reese M, Mittelman MS. Effects of the Minnesota Adaptation of the NYU Caregiver Intervention on Depressive Symptoms and Quality of Life for Adult Child Caregivers of Persons with Dementia. Am J Geriatr Psychiatry. 2015 Nov;23(11):1179-92. doi: 10.1016/j.jagp.2015.06.007. Epub 2015 Jun 25. — View Citation

Goble DJ, Cone BL, Fling BW. Using the Wii Fit as a tool for balance assessment and neurorehabilitation: the first half decade of "Wii-search". J Neuroeng Rehabil. 2014 Feb 8;11:12. doi: 10.1186/1743-0003-11-12. — View Citation

Grabiner MD, Kaufman KR. Developing and Establishing Biomechanical Variables as Risk Biomarkers for Preventable Gait-Related Falls and Assessment of Intervention Effectiveness. Front Sports Act Living. 2021 Sep 22;3:722363. doi: 10.3389/fspor.2021.722363. eCollection 2021. — View Citation

Groth-Marnat, G. (2009). Handbook of psychological assessment. John Wiley & Sons.

Haddad M. Depression in adults with a chronic physical health problem: treatment and management. Int J Nurs Stud. 2009 Nov;46(11):1411-4. doi: 10.1016/j.ijnurstu.2009.08.007. No abstract available. — View Citation

Harada ND, Chiu V, Stewart AL. Mobility-related function in older adults: assessment with a 6-minute walk test. Arch Phys Med Rehabil. 1999 Jul;80(7):837-41. doi: 10.1016/s0003-9993(99)90236-8. — View Citation

Heidenblut S, Zank S. Screening for Depression in Old Age With Very Short Instruments: The DIA-S4 Compared to the GDS5 and GDS4. Gerontol Geriatr Med. 2020 Dec 10;6:2333721420981328. doi: 10.1177/2333721420981328. eCollection 2020 Jan-Dec. — View Citation

Heinzel, S., Lawrence, J. B., Kallies, G., Rapp, M. A., & Heissel, A. (2015). Using exercise to fight depression in older adults: A systematic review and meta-analysis. GeroPsych: The Journal of Gerontopsychology and Geriatric Psychiatry, 28(4), 149.

Hu S, Tucker L, Wu C, Yang L. Beneficial Effects of Exercise on Depression and Anxiety During the Covid-19 Pandemic: A Narrative Review. Front Psychiatry. 2020 Nov 4;11:587557. doi: 10.3389/fpsyt.2020.587557. eCollection 2020. — View Citation

Iaboni A, Flint AJ. The complex interplay of depression and falls in older adults: a clinical review. Am J Geriatr Psychiatry. 2013 May;21(5):484-92. doi: 10.1016/j.jagp.2013.01.008. Epub 2013 Feb 6. — View Citation

Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-1983;17(1):37-49. doi: 10.1016/0022-3956(82)90033-4. — View Citation

* Note: There are 42 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biodex Balance System (BBS; Biodex Inc., Shirley, NY)	It will be utilized as a reliable and valid device for measuring balance stability during standing in both static and dynamic situations (Cachupe et al.,2001 and Chen et al., 2014). Two balance tests will be performed: Limit of Stability (LOS) and Fall risk test. Both tests challenge the ability of participants to control and maintain balance by maintaining their center of gravity within their base of support. The Biodex system has both a static and dynamic mode with 12 levels of platform tilt (greatest stability level = level 12; least stability level = level 1). The static mode and dynamic level (11) of platform tilt will be e selected in this study to perform PST and LOS tests.	6 Weeks
Primary	Berg Balance Scale	a 14-item list; each will be scored ranging from (0-4); 0 is the lowest and 4 is the highest function (0 -20 = high fall risk, 21-40 = medium fall risk and 41-56 = low fall risk). This tool is valid and reliable	6 weeks
Primary	The Timed Up and Go Test (TUG)	It will be used to assess the following parameters in older adults: fall risk, walking ability, balance, and mobility. Participants while wearing regular footwear will start from sitting position by standing up upon therapist's command; walk forward for 3 meters, turn around, walk back to the chair and sit down when timing should stop. Any assistive devices should be noted. It is a reliable, valid, and sensitive test that is a specific measure of the probability for falls among elderly.	6 weeks
Primary	The six-minute walk test (6MWT)	It will assess the distance that the participant's walking capacity for a total of six minutes on a hard, uneven surface. The 6MWT was originally developed in frail elderly patients aged 60-90 years referred to a geriatric hospital. It has been used to determine exercise tolerance changes following interventions for healthy older adults	6 Weeks
Primary	The Beck Depression Inventory (BDI)	It is a 21-items and self-report form used to assess the presence and severity of symptoms of depression in adults (13-80 years old). Questions should be answered upon participant's feeling during last 2 weeks. The BDI takes approximately 10 minutes to complete. The higher the Beck score the higher the feelings of depression; (1-10) These ups and downs are considered normal, (11-16) mild mood disturbance (17-20) borderline clinical depression (21-30) moderate depression (31-40) severe depression above 40 reflects extreme depression. This tool is reliable and has been validated and standardized on geriatric population with relatively less somatic-related items	6 Weeks
Primary	Geriatric Depression Scale - 15 (short form) (GDS-15)	It is a 15-items, and self-report form. All are YES/NO question, each is worth one point and should be answered based on participant's feeling over last week. 10 items indicate presence of depression if answered positively, while the other 5 indicate depression if answered negatively. This form can be completed in approximately 5 to 7 minutes. This tool has been validated and has a high correlation with depressive symptoms and differentiates between depressed from non-depressed patients. It is valid and reliable scale in geriatrics with a cut-off score of 6 on GDS-15 has 94% sensitivity and 85% specificity in community dwelling older adults, while a cut-off score of 5 has 72% sensitivity and 78% specificity in home care patients	6 Weeks
Primary	Depression in Old Age Scale (DIA-S	is a self-report instrument consists of ten (Yes/No) short statements that focus on emotional, motivational, and cognitive symptoms of . It has a higher specificity and internal consistency (Heidenblut & Zank, 2010). This tool is recommended for research and clinical practice (Heidenblut & Zank, 2020). Score ranges from (0-10); where (0 = no depressive symptoms) and (10 = maximal depressive symptoms); where 4 is an indicative for a depressive disorder.	6 Weeks
Primary	Depression Anxiety Stress Scale-21 (DASS-21) Arabic version	is a self-report instrument that consists of three domains; each domain has seven items. Using a four-point Likert scale (0-3), it assesses the negative emotional symptoms. 3 indicates higher severity of negative symptoms. The three domains are: Depression scale, Anxiety scale, and Stress scale. This tool is valid and has excellent reliability.	6 Weeks