Pre-FrailtyPA&P-F&SPNCT06882720
Effects of Otago-based Multicomponent Exercise on Sarcopenia in Pre-Frailty Older Adults in Nursing Homes: A Randomized Controlled Trial
A study testing Exercise in people with Pre-Frailty and Sarcopenia in Elderly, run by Gdansk University of Physical Education and Sport at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-Frailty, Sarcopenia in Elderly
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2025to 28 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 89 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read more
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
- Being tested
- Exercise
- Keywords
- Pre-Frailty, Sarcopenia, Multicomponent Exercise, Elderly People
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Exercise |
| Control group | No intervention | Give only the physical activity necessary for daily living. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 2 weeks
Secondary outcomes (8)
Body Fat Mass
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.
Measured: From enrollment to the end of treatment at 2 weeks
Skeletal Lean Mass
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.
Measured: From enrollment to the end of treatment at 2 weeks
Fat-Free Mass
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.
Measured: From enrollment to the end of treatment at 2 weeks
TUG
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.
Measured: From enrollment to the end of treatment at 2 weeks
ArmCurl
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.
Measured: From enrollment to the end of treatment at 2 weeks
6MWT
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.
Measured: From enrollment to the end of treatment at 2 weeks
5 STS
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.
Measured: From enrollment to the end of treatment at 2 weeks
TandemBalance
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.
Measured: From enrollment to the end of treatment at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start27 Mar 2025
- Primary completion27 Jun 2025
- Study completion28 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pre-FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gdansk University of Physical Education and Sport
- Sponsor type
- University, hospital or other
- Collaborators
- Kunming Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882720
- Sponsor's protocol ID
- AWFiS/2025_3_ZO
- Acronym
- PA&P-F&SP
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study involves the privacy of the participants and therefore cannot be shared.
Publications
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.
PubMed 39400535Zou 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.
PubMed 34974397
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Otago-based Multicomponent Exercise on Sarcopenia in Pre-Frailty Older Adults in Nursing Homes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06882720
- Acronym / sponsor ID
- PA&P-F&SP / AWFiS/2025_3_ZO
- Conditions
- Pre-Frailty, Sarcopenia in Elderly
- Keywords
- Pre-Frailty, Sarcopenia, Multicomponent Exercise, Elderly People
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Gdansk University of Physical Education and SportUniversity, hospital or other
- Collaborators
- Kunming Medical University
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 28 Jun 2025 (actual)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Otago-based Multicomponent Exercise | Experimental | Behavioral: ExerciseThe intervention is based on the Otago Exercise program, which includes cardiopulmonary exercises, resistance exercises, and balance training, with an additional eight resistance exercises. |
| Control group | No intervention | –Give only the physical activity necessary for daily living. |
Who may qualify
- Ages
- 65 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseCardiorespiratory 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. | Behavioural | Otago-based Multicomponent Exercise |
Primary outcome
Gait Speed
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
8 secondary outcomes
Body Fat Mass
Time frame: From enrollment to the end of treatment at 2 weeks
Skeletal Lean Mass
Time frame: From enrollment to the end of treatment at 2 weeks
Fat-Free Mass
Time frame: From enrollment to the end of treatment at 2 weeks
TUG
Time frame: From enrollment to the end of treatment at 2 weeks
ArmCurl
Time frame: From enrollment to the end of treatment at 2 weeks
6MWT
Time frame: From enrollment to the end of treatment at 2 weeks
5 STS
Time frame: From enrollment to the end of treatment at 2 weeks
TandemBalance
Time frame: From enrollment to the end of treatment at 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Results publication: PubMed 39400535Saez 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.
- Results publication: PubMed 34974397Zou 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.
- Individual participant dataSharing planned: No. This study involves the privacy of the participants and therefore cannot be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Pre-Frailty and Sarcopenia in Elderly, run by Gdansk University of Physical Education and Sport at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Speed (time frame: From enrollment to the end of treatment at 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06882720, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.