Clinical trial NCT05846633: Effectiveness of C-Mill Treadmill Training Versus Conventional Treadmill on Balance and Psychological Status in Elderly
Official title: Effectiveness of C-Mill Treadmill Training Versus Conventional Treadmill on Balance and Psychological Status in Elderly Population: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Elderly
Geriatric
Keywords: elderly
fall risk
gait
balance
virtual reality
treadmill
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 58
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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%.

Detailed 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

Eligibility criteria: 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).

Primary outcomes:
measure: Biodex Balance System (BBS; Biodex Inc., Shirley, NY)
timeFrame: 6 Weeks
measure: Berg Balance Scale
timeFrame: 6 weeks
measure: The Timed Up and Go Test (TUG)
timeFrame: 6 weeks
measure: The six-minute walk test (6MWT)
timeFrame: 6 Weeks
measure: The Beck Depression Inventory (BDI)
timeFrame: 6 Weeks
measure: Geriatric Depression Scale - 15 (short form) (GDS-15)
timeFrame: 6 Weeks
measure: Depression in Old Age Scale (DIA-S
timeFrame: 6 Weeks
measure: Depression Anxiety Stress Scale-21 (DASS-21) Arabic version
timeFrame: 6 Weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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