Cognitive ImpairmentNCT06927882
Effects of Whole Body Vibration Therapy on Cognitive Function, Balance, and Quality of Life in Older Adults With Mild Cognitive Impairment
A study testing WBV Therapy Group in people with Cognitive Impairment and Balance, run by Jouf University.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognitive Impairment, Balance, Quality of Life
- What is being tested?
- WBV Therapy Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diagnosis of dementia.
- Severe musculoskeletal or neurological disorders.
- Implanted electronic medical devices (e.g., pacemaker).
- Inability to comprehend study instructions.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Whole Body Vibration Therapy on Cognitive Function, Balance, and Quality of Life in Older Adults With Mild Cognitive Impairment: A Randomized, Double-Blind, Placebo-Controlled Trial
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.
- Conditions
- Cognitive Impairment, Balance, Quality of Life
- Being tested
- WBV Therapy Group, Placebo Group:, Control
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WBV Therapy GroupOther
- 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.
Placebo Group:Other
- 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.
ControlOther
Only assessment at baseline, after 12 weeks and 6 months.
| Study group | Role | What they receive |
|---|---|---|
| WBV Therapy Group | Experimental | * 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. Receives: Other: WBV Therapy Group; Other: Control |
| Placebo Group | Placebo comparator | • 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. Receives: Other: Placebo Group: |
| Control Group | No intervention | Only assessment at baseline, after 12 weeks and 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA) for Cognitive Function
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
Measured: 6 months
Secondary outcomes (3)
Berg Balance Scale
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.
Measured: 6 months
• Quality of Life
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.
Measured: 12 weeks
Timed up and go test
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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start15 Nov 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jouf University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fahad Alanazi, Jouf University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927882
- Sponsor's protocol ID
- JoufU1
- Status last verified
- Nov 2025
- First submitted
- 6 Apr 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whole Body Vibration Therapy on Cognitive Function, Balance, and Quality of Life in Older Adults With Mild Cognitive Impairment: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT06927882
- Acronym / sponsor ID
- JoufU1
- Conditions
- Cognitive Impairment, Balance, Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Jouf UniversityUniversity, hospital or other
- Study start
- 15 Nov 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| WBV Therapy Group | Experimental | Other: WBV Therapy Group, Other: Control* 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. |
| Placebo Group | Placebo comparator | Other: Placebo 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. |
| Control Group | No intervention | –Only assessment at baseline, after 12 weeks and 6 months. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Diagnosis of dementia.
- Severe musculoskeletal or neurological disorders.
- Implanted electronic medical devices (e.g., pacemaker).
- Inability to comprehend study instructions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WBV 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. | Other | WBV Therapy Group |
| Placebo 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. | Other | Placebo Group |
| ControlOnly assessment at baseline, after 12 weeks and 6 months. | Other | WBV Therapy Group |
Primary outcome
Montreal Cognitive Assessment (MoCA) for Cognitive Function
Time frame: 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
3 secondary outcomes
Berg Balance Scale
Time frame: 6 months
• Quality of Life
Time frame: 12 weeks
Timed up and go test
Time frame: 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing WBV Therapy Group in people with Cognitive Impairment and Balance, run by Jouf University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fahad Alanazi, PhD (+966503409217, Fsalenezi@ju.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (MoCA) for Cognitive Function (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.