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

NCT06882720 | Completed

• 1 other identifier: AWFiS/2025_3_ZO
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Frailty; Sarcopenia in Elderly

Keywords

Pre-Frailty; Sarcopenia; Multicomponent Exercise; Elderly People

Outcome Measures

Primary Outcomes (4)

• Gait Speed

  In order to harmonize the pace measurement method, the 2019 Asian Sarcopenia Working Group recommends the time it takes to walk 6 meters at a normal pace from moving as a measure of average pace. The test is carried out in an inspection room that is more than 8 meters long. Crutches that participants normally use can also be used. The start and end of the 6-meter distance are clearly marked. Subjects stand with their toes touching the starting line, and after being instructed to move forward at their usual speed, subjects start walking, inspectors start timing, and when subjects fully cross the 6-meter mark with one foot, inspectors stop timing. The test is performed twice, recording the shortest time (in seconds) required to complete each distance. The smaller the value, the faster the walking speed, the better the physical ability.

  From enrollment to the end of treatment at 2 weeks

• Skeletal muscle index

  The formula for calculating SMI in InBody is as follows: SMI= sum of segmental muscle mass (two arms and two legs) ÷ square of height.

  From enrollment to the end of treatment at 2 weeks

• Hand Strength

  HS was measured to estimate muscle strength and was performed with a hand dynamometer (Jamar Plus Digital Hand Dynamometer, Sammons Preston, USA). During the HS test, participants had to hold the dynamometer in their hand with the arm stretched parallel to the body while being instructed to stand upright. This measure was performed three times on the dominant hand with a rest interval of 1 min between measurements; finally, the best performance was used as the maximum peak (PK) of HS (in kg). The statistical analysis also included mean peak (mean PK).The higher the grip strength value, the greater the muscle strength, the better the physical ability.

  From enrollment to the end of treatment at 2 weeks

• Skeletal Muscle Mass

  Using the Octupole Bioimpedance InBody 770 analyzer (InBody Co. Seoul, Korea), participants wore light clothing and no shoes.The higher the number, the more muscle the human body has.The ideal skeletal muscle content for men is 47% of standard body weight and 42% of standard body weight for women. A 10% move up or down is considered normal.

  From enrollment to the end of treatment at 2 weeks

Secondary Outcomes (8)

• Body Fat Mass

  From enrollment to the end of treatment at 2 weeks

• Skeletal Lean Mass

  From enrollment to the end of treatment at 2 weeks

• Fat-Free Mass

  From enrollment to the end of treatment at 2 weeks

• TUG

  From enrollment to the end of treatment at 2 weeks

• ArmCurl

  From enrollment to the end of treatment at 2 weeks

Other Outcomes (4)

• Body Mass Index

  From enrollment to the end of treatment at 2 weeks

• EQ-5D-5L

  From enrollment to the end of treatment at 2 weeks

• SPPB（Short Physical Performance Battery）

  From enrollment to the end of treatment at 2 weeks

Study Arms (2)

Otago-based Multicomponent Exercise

EXPERIMENTAL

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

Behavioral: Exercise

Control group

NO INTERVENTION

Give only the physical activity necessary for daily living.

Interventions

Exercise 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.

Otago-based Multicomponent Exercise

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gdansk University of Physical Education and Sport: lead
• Kunming Medical University: collaborator

Study Sites (1)

Kunming Medical University

Kunming, Yunnan, 650000, China

Location

Related Publications (2)

• 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.

  PMID: 39400535 BACKGROUND

• 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.

  PMID: 34974397 BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 18, 2025
• Study Start: March 27, 2025
• Primary Completion: June 27, 2025
• Study Completion: June 28, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)