Community-Based Program Integrating Nurse-Led Mind-Body Exercise and Nutrition for Frailty

ConditionFrail Elderly
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-75
SponsorUniversitas Airlangga

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nurse-Led Mind-Body Exercise (MBE)

    Behavioral

    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

Treatment groups

48 Participants
are divided into 3 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: Nurse Led Mind-Body ExerciseExperimental treatment 1 intervention
Group C: Nurse Led Mind-Body Exercise and Nutritional SupplementationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline (Week 0) and post-intervention at Week 8

Secondary outcomes

1

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.

Time frame
Baseline (Week 0) and post-intervention at Week 8
2

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.

Time frame
Baseline (Week 0) and post-intervention at Week 8
3

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.

Time frame
Baseline (Week 0) and post-intervention at Week 8
4

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.

Time frame
Baseline (Week 0) and post-intervention at Week 8

Other outcomes

Sponsors and contacts

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Universitas Airlangga

Lead sponsor

Universiti Sultan Zainal Abidin

Collaborator

Caritas Institute of Higher Education

Collaborator

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