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Trial registered on ANZCTR


Registration number
ACTRN12624001154594
Ethics application status
Approved
Date submitted
25/07/2024
Date registered
23/09/2024
Date last updated
29/09/2024
Date data sharing statement initially provided
23/09/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Distinctive Effects of Combined Physical Cognitive Training and Physical Training on Fall and Fall-Related Outcomes in Institutionalized Older Adults with Mild Cognitive Impairment
Scientific title
Distinctive Effects of Combined Physical Cognitive Training and Physical Training on Fall and Fall-Related Outcomes in Institutionalized Older Adults with Mild Cognitive Impairment
Secondary ID [1] 312623 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PCT (Physical Cognitive Training)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment 334566 0
Condition category
Condition code
Mental Health 331169 331169 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Cognitive Physical Training (PCT) intervention will be conducted in groups of 8-9 participants, led by an instructor and assisted by a facilitator, typically a local nurse. The PCT program will run for 12 weeks, with sessions held twice weekly, totaling 24 sessions, each lasting 50 minutes. Before each session, participants will submit a notebook to the facilitator, who will use it to record attendance, vital signs at the start of the session, and any complaints or falls reported by participants. The instructor will demonstrate the exercises while the facilitator ensures that all participants follow the movements and instructions correctly. The principal investigator will be present at each session to observe and provide feedback to the instructor to correct any deviations from the procedure.

The physical exercise focuses on improving muscle strength and balance in the lower extremities. It includes a sequence of exercises such as range of motion movements (e.g., head, shoulder, arm, back, waist, and leg stretches), strength training (e.g., leg lifts, squats, heel raises, step-ups), and balance exercises (e.g., standing on one foot, sit-to-stand, and heel-to-toe walking). Each exercise segment is timed, with warm-up, strength, balance, and breathing exercises lasting 30 minutes. All exercises will be standardized across participants, ensuring a similar level of physical ability among them. However, the facilitator will assist those with limitations, and specific movements can be modified to be performed in a seated position if necessary.

Cognitive Stimulation Therapy (CST) will follow the physical exercise session, consisting of three phases: introduction, the main activity, and a final activity. The same instructor and facilitator will guide the CST sessions, utilizing various tools according to each session's topic. Essential items such as a large desk calendar for time orientation and a small whiteboard will be used in all sessions. For instance, in the first session, a rubber ball will be provided for a ball-throwing activity, and in the second session, recorded sounds (e.g., birds chirping or motorbike noises) will be played for a listening activity. Other tools include songbooks, old-fashioned toys, grocery replicas, photographs, maps, playing cards, and quiz books to stimulate cognitive engagement.
Intervention code [1] 329141 0
Treatment: Other
Intervention code [2] 329266 0
Rehabilitation
Comparator / control treatment
The physical exercise regimen for the control group is identical to the physical exercises conducted with the PCT intervention group. The Physical Training (PT) intervention involves participants engaging in a 30-minute structured exercise program designed to enhance muscle strength, balance, and range of motion, which is crucial for fall prevention. Conducted in small peer groups and led by trained leaders with the assistance of facilitators, the exercises include range of motion activities (five minutes), balance exercises (ten minutes), muscle strength training (ten minutes), and deep breathing exercises (five minutes). Sessions are held indoors with participants seated in a circle, and each session begins with assessing vital signs to ensure participants' readiness. The PT intervention focuses solely on physical exercises, with leaders and facilitators encouraging active participation.
Control group
Active

Outcomes
Primary outcome [1] 338932 0
Balance
Timepoint [1] 338932 0
Baseline: 12 weeks after the intervention and three months after the follow-up phase.
Primary outcome [2] 338933 0
Muscle strength
Timepoint [2] 338933 0
The baseline is 12 weeks after intervention and three months after follow-up.
Primary outcome [3] 338934 0
Fear of fall
Timepoint [3] 338934 0
The baseline is 12 weeks after intervention and three months after follow-up.
Secondary outcome [1] 437948 0
Fall incidence
Timepoint [1] 437948 0
The baseline is 12 weeks after intervention and three months after follow-up.

Eligibility
Key inclusion criteria
Inclusion criteria consist of age of 60 years old or above, ability to walk with or without an assistive device, score Mini-Mental State Exam (MMSE) 13= score = 24 (indicating moderate-mild cognitive impairment), and proficiency in Bahasa Indonesia. A score of 13 on the MMSE was used as the lowest cutoff point for inclusion criteria considering the educational background (Fagundes et al., 2021).
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include participation in another trial, lower limb orthopedic surgery, and comorbidities such as cancer, neurological or physiatric disorders, and significant visual or auditory impairments (Liu-Ambrose et al., 2019; Sipilä et al., 2018).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using procedures like coin-tossing and dice-rolling
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The statistical analysis for this study will be conducted using IBM SPSS for Windows version 25 and will include univariate, bivariate, and multivariate analyses. The Intention-to-Treat (ITT) method will be used to maintain randomization integrity and reflect compliance and dropout in clinical practice. Data cleaning and initial Intraclass Correlation Coefficient (ICC) analysis will ensure internal and between-cluster variability is accounted for, confirming cluster homogeneity. Univariate analysis will detail variable characteristics, using central tendencies, standard deviations, and percentages for numeric and categorical data. Bivariate analysis will employ the Friedman test on binary-dependent data to assess intervention effects, ensuring group homogeneity via the Levene test. Multivariate analysis will use the Generalized Estimating Equation (GEE) with a binomial distribution and logit link to compare intervention effectiveness on dependent variables, accounting for demographic and participant characteristics. This approach aims to elucidate the relationships between independent variables, covariates, and outcomes.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
23/09/2024
Actual
5/09/2024
Date of last participant enrolment
Anticipated
28/09/2024
Actual
9/09/2024
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
68
Accrual to date
Final
68
Recruitment outside Australia
Country [1] 26474 0
Indonesia
State/province [1] 26474 0
Jakarta

Funding & Sponsors
Funding source category [1] 317058 0
University
Name [1] 317058 0
Universitas Indonesia
Country [1] 317058 0
Indonesia
Funding source category [2] 317060 0
University
Name [2] 317060 0
National Cheng Kung University
Country [2] 317060 0
Taiwan, Province Of China
Primary sponsor type
Individual
Name
.Dwi Nurviyandari Kusuma Wati - National Cheng Kung University
Address
Country
Indonesia
Secondary sponsor category [1] 319307 0
None
Name [1] 319307 0
Address [1] 319307 0
Country [1] 319307 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315808 0
Faculty of Nursing, Universitas Indonesia Ethics Committee
Ethics committee address [1] 315808 0
https://nursing.ui.ac.id/kepk-fikui/
Ethics committee country [1] 315808 0
Indonesia
Date submitted for ethics approval [1] 315808 0
26/07/2024
Approval date [1] 315808 0
15/08/2024
Ethics approval number [1] 315808 0
KET-206/UN2.F12.D1.2.1/PPM.00.02/2024

Summary
Brief summary
This study aims to evaluate the effectiveness of combined physical and cognitive training versus physical training alone in reducing falls and improving balance, muscle strength, and fear of falling among older adults with mild cognitive impairment in Jakarta, Indonesia. The study will involve 68 participants, randomly assigned to either the combined intervention or physical training alone, with assessments conducted at baseline, 12 weeks post-intervention, and 12 weeks follow-up. Using a Cluster Randomized Controlled Trial (CRCT) design, the study will employ various validated instruments and apply Intention-to-Treat (ITT) analysis with Generalized Estimating Equation (GEE) for statistical analysis. The hypothesis is that the combined intervention will be more effective in reducing falls and improving related outcomes compared to physical training alone. This research could provide a valuable solution for fall prevention among older adults in care institutions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135866 0
Ms Dwi Nurviyandari Kusuma Wati
Address 135866 0
Building A, 2nd Floor, Rumpun Ilmu Kesehatan (RIK), UI Depok Campus, West Java 16424
Country 135866 0
Indonesia
Phone 135866 0
+62 21 78849120
Fax 135866 0
Email 135866 0
[email protected]
Contact person for public queries
Name 135867 0
Dwi Nurviyandari Kusuma Wati
Address 135867 0
Building A, 2nd Floor, Rumpun Ilmu Kesehatan (RIK), UI Depok Campus, West Java 16424
Country 135867 0
Indonesia
Phone 135867 0
+62 21 78849120
Fax 135867 0
Email 135867 0
[email protected]
Contact person for scientific queries
Name 135868 0
Dwi Nurviyandari Kusuma Wati
Address 135868 0
Building A, 2nd Floor, Rumpun Ilmu Kesehatan (RIK), UI Depok Campus, West Java 16424
Country 135868 0
Indonesia
Phone 135868 0
+62 21 78849120
Fax 135868 0
Email 135868 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Informed Consent Restrictions:
Participants may not have given explicit consent to share their data beyond the specific study. Data sharing without appropriate consent can violate ethical standards and legal regulations.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24038Study protocol    388202-(Uploaded-25-07-2024-18-26-50)-Proposal_DwiNurviyandari.pdf



Results publications and other study-related documents

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