NCT07418762

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 30, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2026

Completed
Last Updated

February 18, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

February 11, 2026

Last Update Submit

February 11, 2026

Conditions

Frail Elderly

Keywords

FrailtyElderlyNurse Led Mind-Body

Outcome Measures

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

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

Secondary Outcomes (5)

  • Changes in Lower Extremity Physical Performance of the Elderly

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

  • Changes in Functional Mobility and Fall Risk of the Elderly

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

  • Changes in Pulmonary Function of the Elderly

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

  • Changes in Body Composition of the Elderly

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

  • Changes in Inflammatory Biomarkers Related to Frailty of the Elderly

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

Study Arms (3)

Control

NO INTERVENTION

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.

Nurse Led Mind-Body Exercise

EXPERIMENTAL

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)

Nurse Led Mind-Body Exercise and Nutritional Supplementation

EXPERIMENTAL

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)

Interventions

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

Nurse Led Mind-Body ExerciseNurse Led Mind-Body Exercise and Nutritional Supplementation

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitas Airlangga

Surabaya, East Java, 60115, Indonesia

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Rista Fauziningtyas, S.Kep., Ns., M.Kep., Ph.D

CONTACT

+6281330718027ristafauzinigtyas@fkp.unair.ac.id

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
Rista Fauziningtyas, S.Kep., Ns., M.Kep., Ph.D

Study Record Dates

First Submitted

February 11, 2026

First Posted

February 18, 2026

Study Start

March 30, 2026

Primary Completion

May 25, 2026

Study Completion

May 25, 2026

Last Updated

February 18, 2026

Record last verified: 2026-01

Locations

ID(1)