Balance, Cognitive Impairment, Quality of Life
Conditions
Brief summary
This is a double-blind, randomized controlled trial comparing WBV therapy with a placebo intervention and standard care. A total of 150 participants will be recruited and investigated from Prince Mutib Hospital. Participants will be randomly allocated to one of three groups: WBV therapy, placebo (non-vibrating platform), or control (standard care). The study duration will be 12 weeks, with assessments conducted at baseline, post-intervention (12 weeks), and at a 6-month follow-up. Protocol Parameters Summary * Session Frequency: 3 times per week. * Session Duration: 25 minutes per session. * Vibration Frequency: 30 Hz. * Amplitude: 1-2 mm. * Program Duration: 12 weeks.
Interventions
OTHERWBV Therapy Group
* Frequency: 3 sessions per week for 12 weeks. * Duration: 25 minutes per session. * Vibration Parameters: Participants will undergo whole body vibration therapy at a frequency of 30 Hz, for 25 minutes per session, 3 times a week, with an amplitude of 1-2 mm, over a duration of 12 weeks.
OTHERPlacebo Group:
• Participants will stand on a non-vibrating platform and perform similar static and dynamic exercises for the same duration. The platform will mimic the active intervention's noise and display settings to maintain blinding.
OTHERControl
Only assessment at baseline, after 12 weeks and 6 months.
Sponsors
Jouf University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 60 years and older. * Diagnosed with mild cognitive impairment (Montreal Cognitive Assessment (MoCA) score of 18-25). One point is added if years of education are less than 12 years\[2\]. * Able to stand independently or with minimal assistance. * No contraindications for WBV therapy or exercise.
Exclusion criteria
* Diagnosis of dementia. * Severe musculoskeletal or neurological disorders. * Implanted electronic medical devices (e.g., pacemaker). * Inability to comprehend study instructions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montreal Cognitive Assessment (MoCA) for Cognitive Function | 6 months | Assessed using the standard Arabic version of the Montreal Cognitive Assessment (MoCA) at baseline, 12 weeks, and 6 months. The tool is a reliable and valid instrument to detect MCI among the elderly. The maximum score is 0-30, with higher scores indicating better cognitive functioning. A score below 26 typically suggests cognitive impairment. These tests evaluate changes in executive function, attention, and overall cognitive ability. The investigator will use the standard Arabic version used among community dwelling Saudi Arabians population with changes in some word to make it suitable for the Arabic speaking Saudi Arabian population |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Berg Balance Scale | 6 months | Balance was assessed using the Berg Balance Scale (BBS), a validated and reliable 14-item tool for measuring functional balance. Each item was scored from 0 to 4, with a maximum total of 56. Higher scores reflect better balance performance. The Arabic-translated version, previously validated for clinical use, was administered at baseline, 12 weeks, and 6 months. |
| • Quality of Life | 12 weeks | Health-related quality of life (HRQoL) was measured using the Arabic version of the Short Form-36 Health Survey (SF-36). This self-reported tool comprises 36 items that assess eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality (energy/fatigue), social functioning, role limitations due to emotional problems, and mental health. Scores for each domain range from 0 to 100, with higher scores indicating better health status. The Arabic version has been culturally adapted and validated for use among Arabic-speaking populations, ensuring both linguistic and conceptual equivalence. |
| Timed up and go test | 6 month | Mobility and fall risk were assessed using the Timed Up and Go (TUG) test. Participants were instructed to stand from a seated position, walk 3 meters, turn around, return, and sit down. The time to complete the task was measured in seconds. Higher times indicate reduced mobility and increased fall risk. A TUG time greater than 13.5 seconds is considered indicative of elevated fall risk. |
Contacts
Primary ContactFahad Alanazi, PhD
Outcome results
None listed