NCT06611202

Brief 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. 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:

  1. 1.Physiotherapy Impact: To determine the specific effects of physiotherapy on mobility, endurance, and balance in dementia patients using validated, objective measures.
  2. 2.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.
  3. 3.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.
  4. 4.Dietary Support Role: To investigate the influence of integrated dietary support on physical activity levels, nutritional status, and overall health.
  5. 5.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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 24, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

January 6, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

September 24, 2024

Status Verified

September 1, 2024

Enrollment Period

11 months

First QC Date

September 19, 2024

Last Update Submit

September 20, 2024

Conditions

Keywords

older adultphysical activitycognitive impairmentmental health

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    8 weeks

Secondary Outcomes (3)

  • Functional tasks

    8 weeks

  • mental health and cognition

    8 weeks

  • mental health and cognition

    8 weeks

Study Arms (1)

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

Other: ExerciseDrug: Clonazepam

Interventions

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.

Also known as: walking, remniscent therapy, functional activities
six minute walking group

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.

six minute walking group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Must be free from acute comorbidities: Heart failure; hearing loss;
  • Free from significant visual impairment
  • Must be free from orthostatic hypotension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holbrook ward

Sidcup, da146lt, United Kingdom

Location

MeSH Terms

Conditions

DementiaMotor ActivityCognitive DysfunctionPsychological Well-Being

Interventions

ExerciseWalkingClonazepam

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersBehaviorCognition DisordersPersonal Satisfaction

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaLocomotionBenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Tolulope Adeniji, PhD

CONTACT

Helen Macklin, B.Sc OT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single-group pretest-post-test design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 19, 2024

First Posted

September 24, 2024

Study Start

January 6, 2025

Primary Completion

November 20, 2025

Study Completion

December 20, 2025

Last Updated

September 24, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations