The Effects of Intelligent Intervention Programs on Hospitalized Elderly People With Frailty.

NCT06875024 | Not Yet Recruiting

• 1 other identifier: CJHsieh
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

Background: As the aging population grows, hospitalized elderly individuals with frailty have become a major concern. Frailty is a complex syndrome linked to aging, marked by dependency and vulnerability. Elderly patients often face chronic diseases, making them more susceptible to frailty. Studies show frailty prevalence in hospitalized elderly patients is 88.7%, and 75.3% among kidney disease patients. Frailty is associated with advanced age, female gender, low body mass index, comorbidities, and poor nutrition, increasing the risks of falls, hospitalization, and mortality. Frail kidney disease patients face worse outcomes. However, frailty is reversible with early intervention. Current treatments, based on comprehensive geriatric assessment (CGA), require significant resources. This study aims to explore frailty prevention and care through research and intervention development. Purpose: To explore the effectiveness of an intelligent intervention program in improving frailty among hospitalized elderly individuals. Methods: An experimental research design was adopted. A total of 156 hospitalized elderly patients with kidney disease who met the inclusion criteria were recruited through convenience sampling. Participants were randomly assigned to either the experimental group (n = 78) or the control group (n = 78). The experimental group received a 12-week intelligent intervention program, while the control group received routine care.Subsequently, data on frailty level, daily living function 30 days after discharge, and unexpected readmission rate 30 days after discharge will be collected by researchers and analyzed using SPSS 22.0, including chi-square tests, repeated measures ANOVA, and Generalized Estimating Equations (GEE) for intra-group and inter-group comparisons of each outcome variable. Expected research results: This study aims to understand the current status and influencing factors of frailty among hospitalized elderly patients with kidney disease and to develop an intelligent intervention program. The goal is to provide clinical nursing staff with a frailty care strategy for hospitalized patients, effectively reducing frailty among elderly inpatients, improving their daily functional ability after discharge, and decreasing hospital readmission rates. Condition or disease: frailty Intervention/treatment: intelligent intervention program

Conditions

Frailty in Older Adults

Outcome Measures

Primary Outcomes (12)

• Fried frailty phenotype

  Number of Participants Classified as Frail or Pre-Frail Based on the Fried Frailty Phenotype Criteria: Unintentional Weight Loss, Exhaustion, Weak Grip Strength, Slow Walking Speed, and Low Physical Activity

  pre-intervention, baseline (T0)

• Fried frailty phenotype

  Number of Participants Classified as Frail or Pre-Frail Based on the Fried Frailty Phenotype Criteria: Unintentional Weight Loss, Exhaustion, Weak Grip Strength, Slow Walking Speed, and Low Physical Activity

  4 weeks after intervention, discharge(T1)

• Fried frailty phenotype

  Number of Participants Classified as Frail or Pre-Frail Based on the Fried Frailty Phenotype Criteria: Unintentional Weight Loss, Exhaustion, Weak Grip Strength, Slow Walking Speed, and Low Physical Activity

  8 weeks after intervention(T2)

• Fried frailty phenotype

  Number of Participants Classified as Frail or Pre-Frail Based on the Fried Frailty Phenotype Criteria: Unintentional Weight Loss, Exhaustion, Weak Grip Strength, Slow Walking Speed, and Low Physical Activity

  12 weeks after intervention(T3)

• physical activity function- Activities of daily living(ADL)

  This tool evaluates an individual's ability to perform self-care activities in daily life, including eating, mobility, personal hygiene, toileting, bathing, walking, stair climbing, dressing, bowel control, and bladder control. Each activity is scored based on the individual's level of independence, with total scores ranging from 0 to 100, where higher scores indicate better daily functioning . The Cronbach's α of the scale is 0.82, test-retest reliability is 0.89, and inter-rater reliability is 0.95 (0.91-0.97) .

  pre-intervention, baseline (T0)

• physical activity function- Activities of daily living(ADL)

  This tool evaluates an individual's ability to perform self-care activities in daily life, including eating, mobility, personal hygiene, toileting, bathing, walking, stair climbing, dressing, bowel control, and bladder control. Each activity is scored based on the individual's level of independence, with total scores ranging from 0 to 100, where higher scores indicate better daily functioning. The Cronbach's α of the scale is 0.82, test-retest reliability is 0.89, and inter-rater reliability is 0.95 (0.91-0.97).

  4 weeks after intervention, discharge(T1)

• physical activity function- Activities of daily living(ADL)

  This tool evaluates an individual's ability to perform self-care activities in daily life, including eating, mobility, personal hygiene, toileting, bathing, walking, stair climbing, dressing, bowel control, and bladder control. Each activity is scored based on the individual's level of independence, with total scores ranging from 0 to 100, where higher scores indicate better daily functioning . The Cronbach's α of the scale is 0.82, test-retest reliability is 0.89, and inter-rater reliability is 0.95 (0.91-0.97) .

  8 weeks after intervention(T2)

• physical activity function- Activities of daily living(ADL)

  This tool evaluates an individual's ability to perform self-care activities in daily life, including eating, mobility, personal hygiene, toileting, bathing, walking, stair climbing, dressing, bowel control, and bladder control. Each activity is scored based on the individual's level of independence, with total scores ranging from 0 to 100, where higher scores indicate better daily functioning . The Cronbach's α of the scale is 0.82, test-retest reliability is 0.89, and inter-rater reliability is 0.95 (0.91-0.97) .

  12 weeks after intervention(T3)

• physical activity function-Chair Stand Test

  A tool for assessing lower limb muscular endurance in older adults, as part of the Senior Fitness Test developed by the Sports Administration, Ministry of Education, Taiwan . The test involves the participant sitting on a chair with their arms crossed over their chest. They are instructed to stand up and sit down once, which is counted as one repetition. The total number of repetitions completed within 30 seconds is recorded. The performance is classified into five levels-poor, below average, average, above average, and excellent-based on gender- and age-specific standards. This study follows the normative fitness standards for older adults established by the Sports Administration, Ministry of Education .

  pre-intervention, baseline (T0)

• physical activity function-Chair Stand Test

  A tool for assessing lower limb muscular endurance in older adults, as part of the Senior Fitness Test developed by the Sports Administration, Ministry of Education, Taiwan. The test involves the participant sitting on a chair with their arms crossed over their chest. They are instructed to stand up and sit down once, which is counted as one repetition. The total number of repetitions completed within 30 seconds is recorded. The performance is classified into five levels-poor, below average, average, above average, and excellent-based on gender- and age-specific standards. This study follows the normative fitness standards for older adults established by the Sports Administration, Ministry of Education.

  4 weeks after intervention, discharge(T1)

• physical activity function-Chair Stand Test

  A tool for assessing lower limb muscular endurance in older adults, as part of the Senior Fitness Test developed by the Sports Administration, Ministry of Education, Taiwan. The test involves the participant sitting on a chair with their arms crossed over their chest. They are instructed to stand up and sit down once, which is counted as one repetition. The total number of repetitions completed within 30 seconds is recorded. The performance is classified into five levels-poor, below average, average, above average, and excellent-based on gender- and age-specific standards. This study follows the normative fitness standards for older adults established by the Sports Administration, Ministry of Education.

  8 Weeks after intervention(T2)

• physical activity function-Chair Stand Test

  A tool for assessing lower limb muscular endurance in older adults, as part of the Senior Fitness Test developed by the Sports Administration, Ministry of Education, Taiwan. The test involves the participant sitting on a chair with their arms crossed over their chest. They are instructed to stand up and sit down once, which is counted as one repetition. The total number of repetitions completed within 30 seconds is recorded. The performance is classified into five levels-poor, below average, average, above average, and excellent-based on gender- and age-specific standards. This study follows the normative fitness standards for older adults established by the Sports Administration, Ministry of Education.

  12 Weeks after intervention(T3)

Secondary Outcomes (16)

• 15-item geriatric depression scale(GDS-15)

  pre-intervention, baseline (T0)

• 15-item geriatric depression scale(GDS-15)

  4 weeks after intervention, discharge(T1)

• 15-item geriatric depression scale(GDS-15)

  8 Weeks after intervention(T2)

• 15-item geriatric depression scale(GDS-15)

  12 Weeks after intervention(T3)

• the Chinese version of the Pittsburgh Sleep Quality Index(CPSQI)

  pre-intervention, baseline (T0)

Study Arms (2)

Control group

NO INTERVENTION

The control group received usual care.

Experimental group

EXPERIMENTAL

The experimental group will receive an intelligent intervention program, which includes cycling training during hospitalization and daily walking training after discharge, supplemented by monitoring and tracking using a smart wristband.

Behavioral: Intelligent intervention programs

Interventions

Intelligent intervention programs BEHAVIORAL

The intervention involves a structured exercise program, with participants in the experimental group engaging in cycling exercises three times per week, each session lasting 30 minutes during hospitalization. After discharge, they will follow a walking program, increasing their daily step count by 1,000 steps above the average recorded during hospitalization, for a total of 12 weeks. Structured questionnaires and medical records will be used for data collection at four time points: the first week of enrollment (T0), hospital discharge (T1), the eighth week post-enrollment (T2), and the twelfth week post-enrollment (T3). Additionally, a tri-axial accelerometer-equipped smart wristband will be used to monitor and record participants' heart rate, respiration, blood pressure, daily step count, and sleep quality.

Experimental group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Hospitalized patients aged 65 years and older. (、
• Admitted to the nephrology department or undergoing dialysis.
• Conscious, able to express themselves independently, follow instructions, and communicate in Mandarin or Taiwanese.
• Expected hospital stay of at least six days.
• Assessed using the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) and deemed to have no immediate risk for exercise participation, with normal capability for physical activity.

You may not qualify if:

• Severe visual or hearing impairments that hinder communication or assessments.
• Significant cognitive impairment, defined as a Montreal Cognitive Assessment (MoCA) score \< 24.
• Patients who do not consent to participate in the study.
• Individuals unable to personally complete the consent form.
• Patients receiving palliative care.
• Regular participants in rehabilitation therapy.
• Charlson Comorbidity Index (CCI) score ≥ 5.

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead

Study Sites (1)

National Taipei University of Nursing and Health Sciences, Taipei,

Taipei, Taiwan

Location

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Central Study Contacts

Chia Jung Hsieh

CONTACT

886 2 28227101 ex 3109; chiajung@gm.ntunhs.edu.tw

Hsuan Ju Peng

CONTACT

886 953625708; jiazi1230@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 13, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)