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Distinctive Effects of Combined Physical Cognitive Training and Physical Training on Fall and Fall-Related Outcomes in Institutionalized Older Adults with Mild Cognitive Impairment

Distinctive Effects of Combined Physical Cognitive Training and Physical Training on Fall and Fall-Related Outcomes in Institutionalized Older Adults with Mild Cognitive Impairment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001154594
Acronym
PCT (Physical Cognitive Training)
Enrollment
68
Registered
2024-09-23
Start date
2024-09-05
Completion date
2024-09-09
Last updated
2024-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 particip

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.

Sponsors

.Dwi Nurviyandari Kusuma Wati - National Cheng Kung University
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No

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).

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).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026