CompletedNot Applicable

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

China61 participantsStarted 2025-03-27

Plain-language summary

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.

Who can participate

Age range

65 Years – 89 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Gait Speed

Timeframe: From enrollment to the end of treatment at 2 weeks

Skeletal muscle index

Timeframe: From enrollment to the end of treatment at 2 weeks

Hand Strength

Timeframe: From enrollment to the end of treatment at 2 weeks

Skeletal Muscle Mass

Timeframe: From enrollment to the end of treatment at 2 weeks

Trial details

NCT IDNCT06882720

SponsorGdansk University of Physical Education and Sport

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-27

View on ClinicalTrials.gov More Pre-Frailty trials

Plain-language summary

Who can participate

Age range

65 Years – 89 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Gait Speed

Timeframe: From enrollment to the end of treatment at 2 weeks

Skeletal muscle index

Timeframe: From enrollment to the end of treatment at 2 weeks

Hand Strength

Timeframe: From enrollment to the end of treatment at 2 weeks

Skeletal Muscle Mass

Timeframe: From enrollment to the end of treatment at 2 weeks