Community-Based Program Integrating Nurse-Led Mind-Body Exercise and Nutrition for Frailty (N-CARE Frailty)

Community-Based Rehabilitation Integrating Nurse-Led Mind-Body Exercise and Nutritional Supplementation for Frailty: A Three-Arm Randomized Controlled Trial

This study aims to develop and evaluate a community-based rehabilitation program integrating nurse-led mind-body exercises and nutritional supplementation for frail older adults in Indonesia. This study uses a Randomized Controlled Trial (RCT) with three parallel groups and assessor blinding. The intervention was conducted for 8 weeks in community-dwelling older adults aged ≥ 65 years who live within the working area of a Community Health Center in Surabaya City. The sample size is 48 elderly. Participants will be divided into 3 groups: the control group, the Nurse-Led Mind-Body Exercise group, and the MBE + Nutritional Supplementation (MBE + Nutrition) group. The procedure is carried out after respondents provide voluntary consent. Confidentiality and anonymity of data will be strictly maintained throughout the research process. Data analysis between groups and within groups will be conducted using repeated-measures ANOVA and Intention-to-treat (ITT) analysis.

Study Overview

• Status: Not yet recruiting
• Conditions: Frail Elderly
• Intervention / Treatment: Behavioral: Nurse-Led Mind-Body Exercise (MBE)

Detailed Description

The sample was selected based on inclusion and exclusion criteria. Inclusion criteria were age ≥ 65 years, FRAIL scale score of 0 (robust), 1-3 (pre-frail), and 4-5 (frail), able to stand and walk independently without permanent aids, willing to participate in the 8-week program (three sessions per week), and provide written consent. Exclusion criteria included severe heart or respiratory conditions that would contraindicate exercise, moderate to severe cognitive impairment (MoCA-InaMSE <18), recent stroke or severe musculoskeletal disorder, and known allergies or intolerances to protein supplements. 48 respondents were randomly assigned (stratified by gender and level of frailty) into one of three groups. Respondents who meet the criteria will be given a complete explanation of the research objectives, procedures, potential benefits, minimal risks, and the right to withdraw at any time without consequence. After understanding all this information, respondents will be asked to provide voluntary consent by signing an informed consent form. Once consent is granted, researchers will conduct direct data collection. In this study, subjects will undergo a series of research processes over several weeks. In week 1, direct data collection was conducted through physical examinations and measurements prior to the intervention. This process included measuring physical function using the Short Physical Performance Battery (SPPB) and the Time Up and Go Test (TUGT), measuring respiratory function using a peak flow meter, and examining body composition using Bioelectrical Impedance Analysis (BIA). In addition, blood samples were taken to analyze the levels of inflammatory biomarkers, namely Interleukin-6 (IL-6) and Tumor Necrosis Factor-α. addition, blood samples were taken to analyze the levels of inflammatory biomarkers, namely Interleukin-6 (IL-6) and Tumor Necrosis Factor-α. taken to analyze the levels of inflammatory biomarkers, namely Interleukin-6 (IL-6) and Tumor Necrosis Factor-α.

Respondents in the control group in weeks 2, 3, and 4 will receive education about physical changes in the elderly, healthy lifestyle habits for healthy aging, and participate in integrated health service post (Posyandu) activities. In the following weeks, namely weeks 5, 6, 7, and 8, education will be provided about physical problems that occur in the elderly, activities carried out to prevent frailty, nutrition that helps prevent frailty, and participation in Posyandu activities. The implementation of education and Posyandu will be adjusted to the Posyandu schedule in the region. Respondents in the mind-body exercise group will follow an exercise program aimed at improving muscle strength, balance, body composition, and respiratory function through gentle, integrated movements, focusing on slow resistance, breath control, and relaxation. Exercises are carried out three times per week for 8 weeks, with assistance at each session to ensure safety and correct technique. The program consists of three components: Warm-up (5 minutes): stretching the head, shoulders, hips, and knees, Main exercise (30 minutes): slow resistance training using resistance band tubing and balance and coordination exercises from Otago exercise, Cooling down (10 minutes): static stretching and breathing meditation with chair yoga. In the combination group, respondents follow the entire mind-body exercise program as in the previous group and receive additional protein nutritional supplementation in the form of Ensure Gold Strength Pro milk of 1.2 grams/kgBW/day during the 8-week intervention period, consumed daily after breakfast or after the exercise session. In addition, respondents will also receive an educational session on how to consume Ensure Gold Strength Pro milk. A sample of 16 participants per group was used as a reference because it is appropriate for detecting early trends in effectiveness in a community-based pilot study. Data analysis will include descriptive statistics related to the baseline characteristics of participants. Between-group and within-group comparisons will be conducted using mixed-effect models or repeated-measures ANOVA to assess changes over time and differences between intervention groups. Intention-to-treat (ITT) analysis will be applied to handle missing data, ensuring the reliability of the results. To control for potential type I error due to multiple comparisons, a Bonferroni correction will be applied. Statistical significance will be determined at a threshold of p < 0.05. This study will be reviewed and approved by the Ethics Committee of the Faculty of Nursing, Airlangga University. All participants will receive a detailed explanation of the study procedures and provide written informed consent before participating. Data confidentiality and anonymity will be strictly maintained throughout the study. This study carries minimal risk to participants, as all activities are performed at a low intensity, and continuous monitoring will be conducted during each session to ensure participant safety.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rista Fauziningtyas, S.Kep., Ns., M.Kep., Ph.D; Phone Number: +6281330718027; Email: ristafauzinigtyas@fkp.unair.ac.id

Study Locations

• Indonesia
  • East Java
    • Surabaya, East Java, Indonesia, 60115
      • Universitas Airlangga
      • Contact: Rista Fauziningtyas, S.Kep., Ns., M.Kep., Ph.D; Phone Number: +6281330718027; Email: ristafauzinigtyas@fkp.unair.ac.id

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Eligibility criteria included age ≥65 years, a Frail Scale score of 1-3 (pre-frail) or 4-5 (frail), ability to stand and walk independently without permanent assistive devices, willingness to participate for eight weeks (three sessions per week), and provision of written informed consent.

Exclusion Criteria:

• Exclusion criteria included severe cardiac or respiratory conditions (contraindications to exercise), moderate to severe cognitive impairment (MoCA-Ina), recent stroke or severe musculoskeletal disorders, and known allergies or intolerance to protein supplements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Participants in the control group received general health education on physical changes in older adults, healthy lifestyles for older adults, common physical problems in aging, frailty prevention activities, and appropriate nutrition to prevent frailty for eight weeks.
Experimental: Nurse Led Mind-Body Exercise; The mind-body exercise intervention group received a structured program led by trained nurses. The exercise sessions consisted of warm-up activities, strength training (resistance band/tubing), balance training (Otago Exercise), and cool-down activities (chair yoga). Sessions were conducted three times per week, 45 minutes per session, over an eight-week period.	Behavioral: Nurse-Led Mind-Body Exercise (MBE); The study will be conducted for 8 weeks. Respondents in the mind-body exercise group will follow an exercise program aimed at improving muscle strength, balance, body composition, and respiratory function through gentle, integrated movements, focusing on gentle resistance, breath control, and relaxation. The exercises will be conducted three times a week for 8 weeks, with assistance at each session to ensure safety and correct technique. The program consists of three components: Warm-up (5 minutes): stretching the head, shoulders, hips, and knees, Main exercise (30 minutes): gentle resistance training using resistance band tubing and balance and coordination exercises from Otago exercise Cool-down (10 minutes): static stretching and breathing meditation with chair yoga. Meanwhile, in the combination group, respondents follow the entire mind-body exercise program as in the previous group and receive additional protein nutritional supplementation in the form of Ensure Gold Strength Pro
Experimental: Nurse Led Mind-Body Exercise and Nutritional Supplementation; The mind-body exercise plus nutritional supplementation group received the same structured exercise intervention combined with daily protein supplementation in the form of Ensure Gold Strength Pro milk at a dose of 1.25 g/kg body weight per day for eight weeks, administered orally.	Behavioral: Nurse-Led Mind-Body Exercise (MBE); The study will be conducted for 8 weeks. Respondents in the mind-body exercise group will follow an exercise program aimed at improving muscle strength, balance, body composition, and respiratory function through gentle, integrated movements, focusing on gentle resistance, breath control, and relaxation. The exercises will be conducted three times a week for 8 weeks, with assistance at each session to ensure safety and correct technique. The program consists of three components: Warm-up (5 minutes): stretching the head, shoulders, hips, and knees, Main exercise (30 minutes): gentle resistance training using resistance band tubing and balance and coordination exercises from Otago exercise Cool-down (10 minutes): static stretching and breathing meditation with chair yoga. Meanwhile, in the combination group, respondents follow the entire mind-body exercise program as in the previous group and receive additional protein nutritional supplementation in the form of Ensure Gold Strength Pro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in frailty status of the elderly	Frailty status of the elderly will be measured using the Indonesian version of the FRAIL scale (Ina-FRAIL). Changes in frailty status will be evaluated by comparing Ina-FRAIL scores at baseline and after the intervention period	Baseline (Week 0) and post-intervention at Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Lower Extremity Physical Performance of the Elderly	Lower extremity physical performance will be assessed using the Short Physical Performance Battery (SPPB), which evaluates balance, gait speed, and standing from a chair. Changes in the total SPPB score will indicate improvement or decline in physical function related to mobility and frailty status.	Baseline (Week 0) and post-intervention at Week 8
Changes in Functional Mobility and Fall Risk of the Elderly	Functional mobility and fall risk will be measured using the Timed Up and Go Test (TUGT). The test will be used to assess changes in dynamic balance, mobility, and fall risk.	Baseline (Week 0) and post-intervention at Week 8
Changes in Pulmonary Function of the Elderly	Pulmonary function will be evaluated using a peak flow meter to measure Peak Expiratory Flow (PEF). Changes in PEF values will indicate alterations in respiratory capacity associated with physical conditioning.	Baseline (Week 0) and post-intervention at Week 8
Changes in Body Composition of the Elderly	Body composition, including muscle mass, fat mass, and body mass index (BMI), will be assessed using Bioelectrical Impedance Analysis (BIA). Changes in these parameters will be used to evaluate the effects of the intervention on nutritional and physical status.	Baseline (Week 0) and post-intervention at Week 8
Changes in Inflammatory Biomarkers Related to Frailty of the Elderly	Levels of inflammatory biomarkers, including Interleukin-6 (IL-6) and Tumor Necrosis Factor-alpha (TNF-α), will be measured using ELISA assays. Changes in biomarker concentrations will reflect inflammatory and metabolic responses related to frailty.	Baseline (Week 0) and post-intervention at Week 8

Collaborators and Investigators

• Sponsor: Universitas Airlangga
• Collaborators: Universiti Sultan Zainal Abidin; Caritas Institute of Higher Education

Study record dates

Study Major Dates

• Study Start (Estimated): March 30, 2026
• Primary Completion (Estimated): May 25, 2026
• Study Completion (Estimated): May 25, 2026

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Elderly; Frailty; Nurse Led Mind-Body
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Frailty
• Other Study ID Numbers: Number: 4027-KEPK; 5461/B/UN3.LPPM/PT.01.03/2025 (Other Grant/Funding Number: Indonesia Endowment Fund for Education Agency (LPDP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No