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

Not Applicable

Completed

• Conditions: Pre-Frailty; Sarcopenia in Elderly

• Registration Number: NCT06882720
• Lead Sponsor: Gdansk University of Physical Education and Sport

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-12
• Study First Posted: 2025-03-18
• Study Start: 2025-03-27
• Primary Completion: 2025-06-27
• Study Completion: 2025-06-28
• Last Update Submitted: 2025-06-30
• Last Update Posted: 2025-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Gait Speed	From enrollment to the end of treatment at 2 weeks	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.
Skeletal muscle index	From enrollment to the end of treatment at 2 weeks	The formula for calculating SMI in InBody is as follows: SMI= sum of segmental muscle mass (two arms and two legs) ÷ square of height.
Hand Strength	From enrollment to the end of treatment at 2 weeks	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.
Skeletal Muscle Mass	From enrollment to the end of treatment at 2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
ArmCurl	From enrollment to the end of treatment at 2 weeks	Participants were asked to sit in a chair holding a 2KG weight with one arm and complete the maximum number of arm curls within 30 seconds. The greater the number of bends, the better the upper body strength may prove.
Body Fat Mass	From enrollment to the end of treatment at 2 weeks	Using the Octupole Bioimpedance InBody 770 analyzer (InBody Co. Seoul, Korea), participants wore light clothing and no shoes.The higher the value of this index, the higher the body fat content.
TUG	From enrollment to the end of treatment at 2 weeks	Time up and go.The TUG test measures the time(s) required for a subject to rise from a chair, walk 3 m, turn around, walk back to the chair, and sit down. It has been shown to be a predictor of sarcopenia in hospitalized patients with a mean age of 70.4±7.7 years.The smaller the value, the shorter the completion time, and the better the physical function.
Skeletal Lean Mass	From enrollment to the end of treatment at 2 weeks	Using the Octupole Bioimpedance InBody 770 analyzer (InBody Co. Seoul, Korea), participants wore light clothing and no shoes. The calculation method of SLM is different from that of SMM. The SLM in InBody report paper is the sum of protein, body water, and extracosseous inorganic salts. The ideal SLM for men is 80% of standard body weight and 72% of standard body weight for women. A 10% move up or down is considered normal.
Fat-Free Mass	From enrollment to the end of treatment at 2 weeks	Using the Octupole Bioimpedance InBody 770 analyzer (InBody Co. Seoul, Korea), participants wore light clothing and no shoes. The higher the value of this index, the heavier the body weight without fat.
6MWT	From enrollment to the end of treatment at 2 weeks	6MWT is used to assess an individual's cardiopulmonary function, exercise tolerance, and overall functional status. It measures the distance patients walk at maximum capacity in six minutes, reflecting their daily activity endurance and the adaptability of their cardiorespiratory system. For a round trip walk in a 50-meter long corridor, the recorder records the exact distance (meters) in 6 minutes. The reference value for healthy elderly people is 400-500 meters for men and 350-450 meters for women. The reference value for the elderly in the early stage of frailty is: men: 300-400 meters, women: 250-350 meters.
5 STS	From enrollment to the end of treatment at 2 weeks	First sit in a chair of the appropriate height, complete 5 consecutive standing and sitting movements, and finally finish in a sitting position, during which no chair is allowed to be held by hand. Record how long it takes to complete the action. The completion time of Pre-Frailty Older Adults is ≥12-15 seconds, if it is greater than 15 seconds, it means that there is a risk of falling, and the risk of limited activity is higher.
TandemBalance	From enrollment to the end of treatment at 2 weeks	Participants used the "toe" stick to the "heel" in a straight line walking way, with the fastest speed to complete 2 meters. The smaller the value, the faster the walking speed, which may represent better balance ability.

Trial Locations

Locations (1)

Kunming Medical University; 🇨🇳 KunMing, Yunnan, China