Effects of Otago-based Multicomponent Exercise on Sarcopenia in Pre-Frailty Older Adults in Nursing Homes: A Randomized Controlled Trial

NCT ID: NCT06882720

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-27

Study Completion Date

2025-06-28

Brief Summary

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The objective of this clinical trial is to understand the efficacy of a targeted exercise program (Otago exercise program+Strength training) in elderly people with prefrailty and sarcopenia. The trial aims to answer the following main questions:

* Is OEP+ST effective in elderly people with prefrailty and sarcopenia?
* In what areas did participants improve during the OEP+ST intervention?

Researchers will randomly assign participants to an experimental group (OEP+ST) and a control group (daily care only) for comparison to see the effects of this intervention.

Participants in the EG group will:

* Exercise 3 times a week for 1 hour each time (including 10 minutes of warm-up, 40 minutes of exercise and 10 minutes of stretching) At the same time, it is necessary to walk for 30-40 minutes three times a week. It lasts for three months.
* Test and record their condition (including frailty, body composition, physical function, quality of life) before and after the experiment.

Detailed Description

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Conditions

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Pre-Frailty Sarcopenia in Elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Otago-based Multicomponent Exercise

The intervention is based on the Otago Exercise program, which includes cardiopulmonary exercises, resistance exercises, and balance training, with an additional eight resistance exercises.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Cardiorespiratory exercises include walking at a normal pace for 30 minutes three times a week, or three 10-minute sessions. The resistance exercises involve five leg muscle strengthening exercises, including knee extensors, knee flexors, hip adductors, ankle plantar flexors, and ankle dorsolflexors, performed 8-10 times, 1-2 sets, 3 times a week, with 1 day intervals in between. Balance training includes 12 exercises such as kneeling, walking backwards, walking and turning, walking sideways, tandem standing (heel-toe standing), tandem walking (heel-toe walking), standing on one leg, walking on the heel, and walking on the tip of the foot. Only 1 set of 1 exercise, 3 times a week, 1 day interval in between. Add 4 upper body strength exercises and 4 lower body strength exercises to the OEP, using water bottles and elastic bands as AIDS. Each movement is completed 8-12 times, 1-3 sets, 3 times a week, 1 day apart.

Control group

Give only the physical activity necessary for daily living.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

Cardiorespiratory exercises include walking at a normal pace for 30 minutes three times a week, or three 10-minute sessions. The resistance exercises involve five leg muscle strengthening exercises, including knee extensors, knee flexors, hip adductors, ankle plantar flexors, and ankle dorsolflexors, performed 8-10 times, 1-2 sets, 3 times a week, with 1 day intervals in between. Balance training includes 12 exercises such as kneeling, walking backwards, walking and turning, walking sideways, tandem standing (heel-toe standing), tandem walking (heel-toe walking), standing on one leg, walking on the heel, and walking on the tip of the foot. Only 1 set of 1 exercise, 3 times a week, 1 day interval in between. Add 4 upper body strength exercises and 4 lower body strength exercises to the OEP, using water bottles and elastic bands as AIDS. Each movement is completed 8-12 times, 1-3 sets, 3 times a week, 1 day apart.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Participants were diagnosed with pre-existing frailty (Fried score 1-2); At the same time, they were also diagnosed with sarcopenia (according to AWGS Asian Sarcopenia Diagnostic Criteria 2019 edition: Grip strength: male \< 28kg, female \< 18kg; SMI: Male \< 7.0kg/m2, female \< 5.4kg/m2; Walking speed ≤1.0 m/s; 5 sit-up test times ≥12s); Simple mental status examination (MMSE score ≥21); There are no absolute contraindications to physical exercise (chest pain, chest tightness, palpitations, dyspnea, syncope, high fever, severe cough, severe diarrhea, gross hematuria, radiating pain in waist and legs, fracture, etc.).

Exclusion Criteria

* Uncontrolled high blood pressure. Coronary artery disease. Rheumatoid arthritis. Type 2 diabetes. Respiratory diseases and lung diseases. Are taking or have used antibiotics and/or antifungal therapy in the past 4 weeks.

Unwillingness to stick to a prescribed schedule.
Minimum Eligible Age

65 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kunming Medical University

OTHER

Sponsor Role collaborator

Gdansk University of Physical Education and Sport

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kunming Medical University

Kunming, Yunnan, China

Site Status

Countries

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China

References

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Saez de Asteasu ML, Martinez-Velilla N, Zambom-Ferraresi F, Garcia-Alonso Y, Galbete A, Ramirez-Velez R, Cadore EL, Izquierdo M. Short-Term Multicomponent Exercise Impact on Muscle Function and Structure in Hospitalized Older at Risk of Acute Sarcopenia. J Cachexia Sarcopenia Muscle. 2024 Dec;15(6):2586-2594. doi: 10.1002/jcsm.13602. Epub 2024 Oct 13.

Reference Type BACKGROUND
PMID: 39400535 (View on PubMed)

Zou Z, Chen Z, Ni Z, Hou Y, Zhang Q. The effect of group-based Otago exercise program on fear of falling and physical function among older adults living in nursing homes: A pilot trial. Geriatr Nurs. 2022 Jan-Feb;43:288-292. doi: 10.1016/j.gerinurse.2021.12.011. Epub 2021 Dec 30.

Reference Type BACKGROUND
PMID: 34974397 (View on PubMed)

Other Identifiers

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AWFiS/2025_3_ZO

Identifier Type: -

Identifier Source: org_study_id

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