Osteosarcopenia; Frailty; Older AdultsNCT07845656
A Home-based Multicomponent Exercise Intervention Program Based on the Fogg Behavior Model (FBM) for Older Adults With Osteosarcopenia and Frailty
A study testing Multi-component home-based exercise intervention based on the Fogg Behavior Model and routine health education and standard nursing care for osteoporosis and regular outpatient follow-up, without extra exercise and nutritional intervention. in people with Osteosarcopenia; Frailty; Older Adults, run by Jiawei Jiang at 2 sites in China.
Trial summary
This study aims to construct and evaluate a home-based multicomponent exercise intervention program based on the Fogg Behavior Model for older adults with osteosarcopenia and frailty. Eligible participants will be randomly divided into two groups. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Osteosarcopenia; Frailty; Older Adults
- What is being tested?
- Multi-component home-based exercise intervention based on the Fogg Behavior Model and routine health education and standard nursing care for osteoporosis and regular outpatient follow-up, without extra exercise and nutritional intervention.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The disease is in stable condition.
- Aged 60-85 years or older.
- Meet the diagnostic criteria in the 2022 Expert Consensus on Sarcopenia-Osteoporosis.
- The score of frailty scale is ≥1, indicating patients are in pre-frailty or frailty status.
- Clear consciousness, normal communication, capable of cooperating with exercise intervention; not living alone and will not leave the residence within half a year.
- Own a smartphone and voluntarily participate in this study.
Who cannot join
- Severe cardiopulmonary, hepatic or renal dysfunction.
- Uncontrolled severe neurological or psychiatric diseases.
- Recent fracture or unable to perform exercise training.
- Malignant tumor, severe infectious disease.
- Participate in other exercise intervention studies simultaneously.
- Cognitive impairment and cannot cooperate with follow-up.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Nantong First People's Hospital
Nantong, Jiangsu, 226000
Yan Hai Gu, Bachelor's degree, 8613862938568, guhaiyan.2009@163.com
- Recruiting
Nantong First People's Hospital
Nantong, Jiangsu, 226001
Li Sun, Master' degree, 8615896264283, sunliborntowin@126.com
Yan Hai Gu, Bachelor
About this study
Official title: Construction and Application of a Home-based Multicomponent Exercise Intervention Program for Older Adults With Osteosarcopenia Complicated by Frailty Based on the Fogg Behavior Model（FBM）
This study aims to construct and evaluate a home-based multicomponent exercise intervention program based on the Fogg Behavior Model for older adults with osteosarcopenia and frailty. Eligible participants will be randomly divided into two groups. The intervention group will receive the home multicomponent exercise guidance built on Fogg Behavior Model, while the control group will get routine health education. We will compare frailty status, muscle strength, physical function,bone mineral density and quality of life between the two groups at baseline, 3 months and 6 months, to explore whether this intervention can improve physical function and reduce frailty in elderly patients with osteosarcopenia.
- Conditions
- Osteosarcopenia; Frailty; Older Adults
- Being tested
- Multi-component home-based exercise intervention based on the Fogg Behavior Model, routine health education and standard nursing care for osteoporosis and regular outpatient follow-up, without extra exercise and nutritional intervention.
- Keywords
- Osteosarcopenia, Frailty, Older adults, Exercise intervention, Fogg Behavior Model, Randomized controlled trial
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-component home-based exercise intervention based on the Fogg Behavior ModelBehavioural
Participants receive a 6-month multi-component home-based exercise intervention based on the Fogg Behavior Model, divided into 3 stages. Stage 1 (Weeks 1-2): motivation cultivation, health assessment, risk screening and health education. Stage 2 (Weeks 3-12): personalized exercise prescription including warm-up, aerobic, resistance, balance and flexibility training, with progressive intensity and regular follow-up. Stage 3 (Months 4-6): habit formation, self-management reinforcement and incentive strategies. The intervention aims to improve muscle mass, physical function and frailty status in older adults with sarcopenia-osteoporosis.
routine health education and standard nursing care for osteoporosis and regular outpatient follow-up, without extra exercise and nutritional intervention.Behavioural
Participants receive routine osteoporosis health education and standard nursing care. General advice on diet, fall prevention and daily activity is provided, without the multi-component staged exercise intervention based on the Fogg Behavior Model. Regular outpatient follow-up is arranged.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Home-based multi-component exercise intervention guided by Fogg Behavior Model, including resistance training, balance training and aerobic exercise for 6 months. Regular follow-up and behavior reminder will be provided. Receives: Behavioral: Multi-component home-based exercise intervention based on the Fogg Behavior Model |
| Control group | Active comparator | Routine health education about osteoporosis and sarcopenia. No systematic supervised exercise intervention. Receives: Behavioral: routine health education and standard nursing care for osteoporosis and regular outpatient follow-up, without extra exercise and nutritional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frailty phenotype score at 6 months
The change of Fried frailty phenotype score from baseline to 6-month follow-up. Fried frailty scale ranges from 0 to 5, higher score means worse frailty status.
Measured: Baseline, 3 months, 6 months
Secondary outcomes (6)
Change in handgrip strength at 6 months
The change of handgrip strength (kg) from baseline to 6-month follow-up
Measured: Baseline, 3 months,6 months
Change in Short Physical Performance Battery (SPPB) score at 6 months
The change of SPPB score from baseline to 6-month follow-up. SPPB ranges from 0 to 12, higher score indicates better physical performance.
Measured: Baseline,3 months, 6 months
Change in skeletal muscle mass index (SMI) at 6 months
The change of skeletal muscle mass index (kg/m²) from baseline to 6-month follow-up, assessed by bioelectrical impedance analysis.
Measured: Baseline,3 months, 6 months
Change in bone mineral density (BMD) at 6 months
The change of lumbar spine bone mineral density (g/cm²) from baseline to 6-month follow-up, measured by dual-energy X-ray absorptiometry (DXA).
Measured: Baseline,6 months
Change in quality of life at 6 months
The change of quality of life measured by the 12-item Short Form Health Survey (SF-12) from baseline to 6-month follow-up.
Measured: Baseline,3 months, 6 months
Incidence of falls within 6 months
The number of participants who experienced fall events during the 6-month intervention period.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteosarcopenia; Frailty; Older AdultsStudies 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
- Model description
- A single-center, two-arm parallel randomized controlled trial. Participants will be randomly assigned to intervention group or control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiawei Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiawei Jiang, Affiliated 2 Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845656
- Sponsor's protocol ID
- 2025LY056
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Application of a Home-based Multicomponent Exercise Intervention Program for Older Adults With Osteosarcopenia Complicated by Frailty Based on the Fogg Behavior Model（FBM）
- ClinicalTrials.gov ID
- NCT07845656
- Acronym / sponsor ID
- 2025LY056
- Conditions
- Osteosarcopenia; Frailty; Older Adults
- Keywords
- Osteosarcopenia, Frailty, Older adults, Exercise intervention, Fogg Behavior Model, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Jiawei JiangUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 Sep 2026 (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.
This study aims to construct and evaluate a home-based multicomponent exercise intervention program based on the Fogg Behavior Model for older adults with osteosarcopenia and frailty. Eligible participants will be randomly divided into two groups. The intervention group will receive the home multicomponent exercise guidance built on Fogg Behavior Model, while the control group will get routine health education. We will compare frailty status, muscle strength, physical function,bone mineral density and quality of life between the two groups at baseline, 3 months and 6 months, to explore whether this intervention can improve physical function and reduce frailty in elderly patients with osteosarcopenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A single-center, two-arm parallel randomized controlled trial. Participants will be randomly assigned to intervention group or control group
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Multi-component home-based exercise intervention based on the Fogg Behavior ModelHome-based multi-component exercise intervention guided by Fogg Behavior Model, including resistance training, balance training and aerobic exercise for 6 months. Regular follow-up and behavior reminder will be provided. |
| Control group | Active comparator | Behavioral: routine health education and standard nursing care for osteoporosis and regular outpatient follow-up, without extra exercise and nutritional intervention.Routine health education about osteoporosis and sarcopenia. No systematic supervised exercise intervention. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The disease is in stable condition.
- Aged 60-85 years or older.
- Meet the diagnostic criteria in the 2022 Expert Consensus on Sarcopenia-Osteoporosis.
- The score of frailty scale is ≥1, indicating patients are in pre-frailty or frailty status.
- Clear consciousness, normal communication, capable of cooperating with exercise intervention; not living alone and will not leave the residence within half a year.
Key exclusion criteria (6 listed)
- Severe cardiopulmonary, hepatic or renal dysfunction.
- Uncontrolled severe neurological or psychiatric diseases.
- Recent fracture or unable to perform exercise training.
- Malignant tumor, severe infectious disease.
- Participate in other exercise intervention studies simultaneously.
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 |
|---|---|---|
| Multi-component home-based exercise intervention based on the Fogg Behavior ModelParticipants receive a 6-month multi-component home-based exercise intervention based on the Fogg Behavior Model, divided into 3 stages. Stage 1 (Weeks 1-2): motivation cultivation, health assessment, risk screening and health education. Stage 2 (Weeks 3-12): personalized exercise prescription including warm-up, aerobic, resistance, balance and flexibility training, with progressive intensity and regular follow-up. Stage 3 (Months 4-6): habit formation, self-management reinforcement and incentive strategies. The intervention aims to improve muscle mass, physical function and frailty status in older adults with sarcopenia-osteoporosis. | Behavioural | Intervention group |
| routine health education and standard nursing care for osteoporosis and regular outpatient follow-up, without extra exercise and nutritional intervention.Participants receive routine osteoporosis health education and standard nursing care. General advice on diet, fall prevention and daily activity is provided, without the multi-component staged exercise intervention based on the Fogg Behavior Model. Regular outpatient follow-up is arranged. | Behavioural | Control group |
Primary outcome
Change in frailty phenotype score at 6 months
Time frame: Baseline, 3 months, 6 months
The change of Fried frailty phenotype score from baseline to 6-month follow-up. Fried frailty scale ranges from 0 to 5, higher score means worse frailty status.
6 secondary outcomes
Change in handgrip strength at 6 months
Time frame: Baseline, 3 months,6 months
Change in Short Physical Performance Battery (SPPB) score at 6 months
Time frame: Baseline,3 months, 6 months
Change in skeletal muscle mass index (SMI) at 6 months
Time frame: Baseline,3 months, 6 months
Change in bone mineral density (BMD) at 6 months
Time frame: Baseline,6 months
Change in quality of life at 6 months
Time frame: Baseline,3 months, 6 months
Incidence of falls within 6 months
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-component home-based exercise intervention based on the Fogg Behavior Model and routine health education and standard nursing care for osteoporosis and regular outpatient follow-up, without extra exercise and nutritional intervention. in people with Osteosarcopenia; Frailty; Older Adults, run by Jiawei Jiang at 2 sites 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Sun, Master' degree (8615896264283, sunliborntowin@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frailty phenotype score at 6 months (time frame: Baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2026.