DementiaNCT06611202
Enhancing Mobility and Mental Health in Dementia Patients
A study testing Exercise and Clonazepam in people with Dementia, run by Oxleas NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study aims to evaluate the effect of a multidisciplinary six-minute walking group and activities on patients with dementia\'s physical activity levels, mobility, anxiety, and cognitive function. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Exercise and Clonazepam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jan 2025to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Clinical diagnosis of dementia.
- Older adults from the age 65 and above
- Must be able to mobilise independently.
- Must be able to engage with minimal tasks that will be based on the
Who cannot join
- Must be free from acute comorbidities: Heart failure; hearing loss;
- Free from significant visual impairment
- Must be free from orthostatic hypotension
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Holbrook ward
Sidcup, da146lt
Holbrook ward Oxleas NHS Foundation Trust, 020 3889 5199, oxl-tr.oxleas-research@nhs.net
Tolulope Adeniji, PhD
About this study
Official title: Enhancing Mobility and Mental Health in Dementia Patients: A Multidisciplinary Six-Minute Walking Group Pilot Study
This study aims to evaluate the effect of a multidisciplinary six-minute walking group and activities on patients with dementia\'s physical activity levels, mobility, anxiety, and cognitive function. The primary objective of this study is to evaluate the effectiveness of a multidisciplinary six-minute walking group intervention-spearheaded by physiotherapists, occupational therapists, and psychologists-in enhancing physical activity, mobility, cognitive function, and functional independence among patients with dementia. A systematic review of existing evidence on the effectiveness of the existing interventions will be conducted to contextualise the findings, providing a robust benchmark for assessing the contribution of each therapeutic component.
Secondary Objectives:
- Physiotherapy Impact: To determine the specific effects of physiotherapy on mobility, endurance, and balance in dementia patients using validated, objective measures.
- Occupational Therapy Contribution: To evaluate the role of occupational therapy in improving functional independence and the ability to perform daily activities through targeted, task-oriented activities.
- Psychological Impact: To assess the psychological benefits of the intervention, including reductions in anxiety and enhancements in mood and overall mental health, as a result of the psychologist-led component.
- Dietary Support Role: To investigate the influence of integrated dietary support on physical activity levels, nutritional status, and overall health.
- Feasibility and Scalability: To explore the practicality of integrating this multidisciplinary intervention into routine dementia care and assess its potential for broader application across similar settings.
Read the detailed description
This study aim to implement and evaluate a multidisciplinary intervention designed to enhance mobility level, cognition and physical activity levels in dementia patients within an inpatient ward. Central to this intervention is a six-minute walking group led collaboratively by physiotherapists, occupational therapists (OT), and psychologists. The program will be augmented by tailored nutritional support from dietitians and ongoing psychiatric/medical team consultation. A vital component of this initiative is a scoping review, which will synthesise existing evidence on similar interventions, providing a robust foundation for the studys design and establishing benchmarks for assessing the effectiveness of each therapeutic element. This project will be piloted within one of our dementia ward, this project has significant potential for broader implementation across other units, directly supporting our mission to enhance the \'Culture of Care\' by integrating evidence-based practices into the daily care routines of dementia patients.
- Conditions
- Dementia
- Being tested
- Exercise, Clonazepam
- Keywords
- older adult, physical activity, cognitive impairment, mental health
- Medical subject headings
- Dementia, Motor Activity, Cognitive Dysfunction, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called walking, remniscent therapy, functional activities
A multidisciplinary six-minute walking group intervention-spearheaded by physiotherapists, occupational therapists, and psychologists-in enhancing physical activity, mobility, cognitive function, and functional independence among patients with dementia.
Physiotherapy Component: A six-minute walking group will be conducted twice a week for 8 weeks, targeting improvements in mobility, endurance, and balance. Occupational Therapy Intervention: Occupational therapists will integrate functional tasks (Games and throwing of balls to court, bean bag target game to enhance exercise relevance to daily activities. A psychologist will provide mental health support during the sessions, utilising techniques like time focus reminiscence therapy to engage patients and reduce anxiety.
ClonazepamDrug
Medication on our dementia wards are being review during ward round and when needs arise. The medication management in drugs will be fully documented and accounted for in the course of the study.
| Study group | Role | What they receive |
|---|---|---|
| six minute walking group | Experimental | Intervention:
Physiotherapy Component: A six-minute walking group will be conducted twice a week for 8 weeks, targeting improvements in mobility, endurance, and balance. Occupational Therapy Intervention: Occupational therapists will integrate functional tasks (Games and throwing of balls to court, bean bag target game to enhance exercise relevance to daily activities. Psychological Support: A psychologist will provide mental health support during the sessions, utilising techniques like time focus reminiscence therapy to engage patients Receives: Other: Exercise; Drug: Clonazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility
A six-minute walking group will be conducted twice a week for 8 weeks, targeting improvements in mobility, endurance, and balance. The impact of physiotherapy will be evaluated using objective tools such as the Tinetti Balance and Gait Assessment. The Tinetti balance subdomain has 16 items, and the gait component has 12 items, with 28 possible outcomes on the tool. The higher the score the better the balance and gait outcome
Measured: 8 weeks
Mobility
A six-minute walking group will be conducted twice a week for 8 weeks, targeting improvements in mobility, endurance, and balance. The impact of physiotherapy will be evaluated using an objective tool called the Elderly Mobility Scale (EMS), with outcomes ranging from 0 to 20. The higher the score the better the mobility level outcome
Measured: 8 weeks
Secondary outcomes (3)
Functional tasks
Occupational therapists will integrate functional tasks, such as ball games involving throwing balls into a court and a bean bag target game, to enhance the relevance of exercises to daily activities. The effectiveness of occupational therapy will be measured by improvements in functional independence using the Pool Activity Level, PAL, Checklist. The Pool Activity Level (PAL) Checklist scores range from 1 to 10, indicating varying degrees of functional independence and engagement in daily activities. A score of 1 to 2 represents profound limitations requiring maximum assistance, while scores of 3 to 4 indicate severe limitations with significant support needed. Moderate independence is reflected in scores of 5 to 6, and scores of 7 to 8 show mild independence, allowing for participation with minimal assistance. Scores of 9 to 10 represent the highest level of independence, where individuals can plan and carry out activities independently. The higher the score the better
Measured: 8 weeks
mental health and cognition
A psychologist will provide mental health support during the sessions, utilising techniques like time focus reminiscence therapy to engage patients and reduce anxiety. The psychological impact will be assessed using the Neuropsychiatric Inventory Questionnaire (NPI-Q). The Neuropsychiatric Inventory Questionnaire, NPI-Q, assesses a range of neuropsychiatric symptoms, with scoring reflecting the severity and frequency of behaviours. Each item is rated based on how often the behaviour occurs from 0 for not at all to 3 for very frequently and the severity of the impact on daily life from 0 for not severe to 3 for very severe. Total scores can range from 0 to 30, with higher scores indicating more significant neuropsychiatric symptoms and a greater psychological impact on the individual. This scoring system helps psychologists evaluate the effectiveness of interventions and tailor support accordingly.
Measured: 8 weeks
mental health and cognition
Therapy team will measure global cognitive function with short version of the IQCODE. The IQCODE short version is a tool used to assess cognitive decline by evaluating an individual\'s abilities over the past 5 or 10 years. It consists of 16 items, each rated on a scale from one to five, with lower scores indicating better cognitive function. Total scores range from 16 to 80, with higher scores suggesting greater cognitive impairment. The scoring helps identify changes in cognitive abilities and aids in the diagnosis of dementia and other cognitive disorders.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start6 Jan 2025 (estimated)
- Primary completion20 Nov 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group pretest-post-test design
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oxleas NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Tolulope Adeniji PhD PT, Oxleas NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611202
- Sponsor's protocol ID
- IRAS Project ID: 349221
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The principal investigator plan to share individual participant data (IPD) with other researchers. Data will include de-identified participant data that support the results reported in the study. Access will be granted to qualified researchers who submit a request along with a scientifically sound proposal, subject to approval by the data-sharing committee.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Mobility and Mental Health in Dementia Patients: A Multidisciplinary Six-Minute Walking Group Pilot Study
- ClinicalTrials.gov ID
- NCT06611202
- Acronym / sponsor ID
- IRAS Project ID: 349221
- Conditions
- Dementia
- Keywords
- older adult, physical activity, cognitive impairment, mental health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Oxleas NHS Foundation TrustUniversity, hospital or other
- Study start
- 6 Jan 2025 (estimated)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 24 Sep 2024 (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 study aims to evaluate the effect of a multidisciplinary six-minute walking group and activities on patients with dementia\'s physical activity levels, mobility, anxiety, and cognitive function. The primary objective of this study is to evaluate the effectiveness of a multidisciplinary six-minute walking group intervention-spearheaded by physiotherapists, occupational therapists, and psychologists-in enhancing physical activity, mobility, cognitive function, and functional independence among patients with dementia. A systematic review of existing evidence on the effectiveness of the existing interventions will be conducted to contextualise the findings, providing a robust benchmark for assessing the contribution of each therapeutic component.
Secondary Objectives:
- Physiotherapy Impact: To determine the specific effects of physiotherapy on mobility, endurance, and balance in dementia patients using validated, objective measures.
- Occupational Therapy Contribution: To evaluate the role of occupational therapy in improving functional independence and the ability to perform daily activities through targeted, task-oriented activities.
- Psychological Impact: To assess the psychological benefits of the intervention, including reductions in anxiety and enhancements in mood and overall mental health, as a result of the psychologist-led component.
- Dietary Support Role: To investigate the influence of integrated dietary support on physical activity levels, nutritional status, and overall health.
- Feasibility and Scalability: To explore the practicality of integrating this multidisciplinary intervention into routine dementia care and assess its potential for broader application across similar settings.
Detailed description
This study aim to implement and evaluate a multidisciplinary intervention designed to enhance mobility level, cognition and physical activity levels in dementia patients within an inpatient ward. Central to this intervention is a six-minute walking group led collaboratively by physiotherapists, occupational therapists (OT), and psychologists. The program will be augmented by tailored nutritional support from dietitians and ongoing psychiatric/medical team consultation. A vital component of this initiative is a scoping review, which will synthesise existing evidence on similar interventions, providing a robust foundation for the studys design and establishing benchmarks for assessing the effectiveness of each therapeutic element. This project will be piloted within one of our dementia ward, this project has significant potential for broader implementation across other units, directly supporting our mission to enhance the \'Culture of Care\' by integrating evidence-based practices into the daily care routines of dementia patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group pretest-post-test design
| Arm | Type | Receives |
|---|---|---|
| six minute walking group | Experimental | Other: Exercise, Drug: ClonazepamIntervention: Physiotherapy Component: A six-minute walking group will be conducted twice a week for 8 weeks, targeting improvements in mobility, endurance, and balance. Occupational Therapy Intervention: Occupational therapists will integrate functional tasks (Games and throwing of balls to court, bean bag target game to enhance exercise relevance to daily activities. Psychological Support: A psychologist will provide mental health support during the sessions, utilising techniques like time focus reminiscence therapy to engage patients |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of dementia.
- Older adults from the age 65 and above
- Must be able to mobilise independently.
- Must be able to engage with minimal tasks that will be based on the
Key exclusion criteria (3 listed)
- Must be free from acute comorbidities: Heart failure; hearing loss;
- Free from significant visual impairment
- Must be free from orthostatic hypotension
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 |
|---|---|---|
| ExerciseAlso: walking, remniscent therapy, functional activitiesA multidisciplinary six-minute walking group intervention-spearheaded by physiotherapists, occupational therapists, and psychologists-in enhancing physical activity, mobility, cognitive function, and functional independence among patients with dementia. Physiotherapy Component: A six-minute walking group will be conducted twice a week for 8 weeks, targeting improvements in mobility, endurance, and balance. Occupational Therapy Intervention: Occupational therapists will integrate functional tasks (Games and throwing of balls to court, bean bag target game to enhance exercise relevance to daily activities. A psychologist will provide mental health support during the sessions, utilising techniques like time focus reminiscence therapy to engage patients and reduce anxiety. | Other | six minute walking group |
| ClonazepamMedication on our dementia wards are being review during ward round and when needs arise. The medication management in drugs will be fully documented and accounted for in the course of the study. | Drug | six minute walking group |
Primary outcome
Mobility
Time frame: 8 weeks
A six-minute walking group will be conducted twice a week for 8 weeks, targeting improvements in mobility, endurance, and balance. The impact of physiotherapy will be evaluated using objective tools such as the Tinetti Balance and Gait Assessment. The Tinetti balance subdomain has 16 items, and the gait component has 12 items, with 28 possible outcomes on the tool. The higher the score the better the balance and gait outcome
Mobility
Time frame: 8 weeks
A six-minute walking group will be conducted twice a week for 8 weeks, targeting improvements in mobility, endurance, and balance. The impact of physiotherapy will be evaluated using an objective tool called the Elderly Mobility Scale (EMS), with outcomes ranging from 0 to 20. The higher the score the better the mobility level outcome
3 secondary outcomes
Functional tasks
Time frame: 8 weeks
mental health and cognition
Time frame: 8 weeks
mental health and cognition
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Individual participant dataSharing planned: Yes. The principal investigator plan to share individual participant data (IPD) with other researchers. Data will include de-identified participant data that support the results reported in the study. Access will be granted to qualified researchers who submit a request along with a scientifically sound proposal, subject to approval by the data-sharing committee.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Clonazepam in people with Dementia, run by Oxleas NHS Foundation Trust at 1 site in United Kingdom.
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 3 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: status not confirmed, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tolulope Adeniji, PhD (+447909485826. ext. +44, tolulopeadeniji86@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobility (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 24 Sep 2024.