Clinical trial NCT06882720: Effects of Otago-based Multicomponent Exercise on Sarcopenia in Pre-Frailty Older Adults in Nursing Homes: a Randomized Controlled Trial
Official title: Effects of Otago-based Multicomponent Exercise on Sarcopenia in Pre-Frailty Older Adults in Nursing Homes: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pre-Frailty
Sarcopenia in Elderly
Keywords: Pre-Frailty
Sarcopenia
Multicomponent Exercise
Elderly People
Lead sponsor: Gdansk University of Physical Education and Sport
Sponsor class: OTHER
Collaborators: name: Kunming Medical University
First posted: 2025-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Gait Speed
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Skeletal muscle index
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Hand Strength
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Skeletal Muscle Mass
timeFrame: From enrollment to the end of treatment at 2 weeks
Secondary outcomes:
measure: Body Fat Mass
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Skeletal Lean Mass
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Fat-Free Mass
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: TUG
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: ArmCurl
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: 6MWT
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: 5 STS
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: TandemBalance
timeFrame: From enrollment to the end of treatment at 2 weeks
Other outcomes:
measure: Body Mass Index
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: EQ-5D-5L
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: SPPB（Short Physical Performance Battery）
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Fried
timeFrame: From enrollment to the end of treatment at 2 weeks
Locations:
city: KunMing
country: China
facility: Kunming Medical University
state: Yunnan
Study officials:
References:
citation: 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.
citation: 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.