OsteopeniaNCT06888544
Effects of High-Intensity Interval Training on Bone Health in Hong Kong Older Women
A study testing HIIT program for 24 weeks with a frequency of 2 times per week. in people with Osteopenia, run by Hong Kong Baptist University at 1 site in China.
Trial summary
Osteoporosis is an age-related disease, characterized by a decreased bone mass and an increased risk of fragility fractures. Osteoporosis leads to increasing mortality, disabilities, morbidity of chronic pain, and the cost of health and social care, as well as decreasing the quality of life from reduced independence… Read more about this study
- Who is it for?
- Ages 60 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteopenia
- What is being tested?
- HIIT program for 24 weeks with a frequency of 2 times per week.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2024to 15 Oct 2026
- 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 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 60 to 74 years at the start date of the project
- diagnosed with osteopenia by DXA scan screening with a BMD at the femoral neck or total hip or lumbar spine between -1 and -2.5 SD T-score below the average values
- Passing the PAR-Q plus screening or with the physician's approval for readiness to participate in high-intensity exercise
- Above the average level of 2-mins stepping showing competent aerobic fitness
- No restriction on physical mobility
- No cognitive impairment, as determined by the Chinese version of the Mini-Mental Status Examination (i.e., score < 24)
- No previous substantial experiences in practicing HIIT. The written informed consent form will be collected from each participant
Who cannot join
- • Severe chronic disease restricting high-intensity exercise
- Having cognition impairment regarded by specialists
- checked through medical records at HA Go app platform in the past 6 months, have concurrent medical conditions (e.g., thyrotoxicosis or hyperparathyroidism, Paget's disease, renal disease, diabetes, knee or hip osteoarthritis) and use medications (e.g., corticosteroids, estrogen, thyroxine, thiazide diuretics, or antiretroviral agents) known to affect bone metabolism during past 2 years
- any condition with osteoporosis, osteoporotic fractures
- current smoker
- alcohol 3 or more units per day.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Bliss District Elderly Community Centre
China, Hong Kong, 999077
Nathan, 852+66879851, boplus@hkcs.org
About this study
Official title: Effects of High-Intensity Interval Training on Bone Health, Physical Fitness and Quality of Life in Elderly Women With Osteopenia: A Pilot Randomized Controlled Trial
Osteoporosis is an age-related disease, characterized by a decreased bone mass and an increased risk of fragility fractures. Osteoporosis leads to increasing mortality, disabilities, morbidity of chronic pain, and the cost of health and social care, as well as decreasing the quality of life from reduced independence and hindered physical, mental, and social well-being.
A recent review and meta-analysis, investigating the association between physical activity and osteoporosis prevention in elderly people, indicated that the traditional exercise interventions (i.e., resistance training) were undertaken for 60+ mins, 2-3 times/week for 7+ months. However, participation rates remain low in these exercise programs among older adults, in part due to a need for specialized equipment and correct techniques to prevent injury. In addition, low motivation and associated compliance with such conventional exercise is problematic among older adults.
Considering there is little evidence of HIIT benefits related to older women with osteopenia, the current study aims to evaluate the effectiveness of a 24-week HIIT intervention on bone mineral density, bone turnover markers and other health-related outcomes among Hong Kong Chinese older women.
Read the detailed description
The study will be a randomized controlled trial (RCT) with two groups and three times repeated measures. Data will be collected in a pretest, post-test, and six months after the intervention. The eligible participants will be randomly distributed into one of two groups in a ratio of 1:1. The participants recruited and meeting the screening criteria will receive a 24-week HIIT intervention or recreation workshop. The intervention effects will be evaluated on bone mineral density, bone turnover markers, physical fitness, fear of falling, and quality of life.
- Conditions
- Osteopenia
- Being tested
- HIIT program for 24 weeks with a frequency of 2 times per week., Non-exercise control
- Keywords
- Osteopenia, Older women, High-intensity interval training
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIT program for 24 weeks with a frequency of 2 times per week.Behavioural
Participants will receive a 24-week HIIT program, with 2 sessions per week. Each session will comprise three sections, including warm-up, main exercise and cool down. The time will be between 37 to 40 minutes with progression of training. Each HIIT section will include six high-impact weight-bearing exercise. For Weeks 1-4, the HIIT section will include 12 intervals of 30 seconds HIIT workout at corresponding intensity, separated by 11 intervals of 60 seconds of active recovery. To ensure the subjects' safety, a chair will be used for assistance during training in the first month. Additionally, a 3 kg weight will be incorporated for the training in the final two months.
Non-exercise controlBehavioural
Workshop participants in the non-exercise control group will receive a series of workshops related to daily recreation.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity interval training (HIIT) | Experimental | HIIT program for 24 weeks with a frequency of 2 times per week. Receives: Behavioral: HIIT program for 24 weeks with a frequency of 2 times per week. |
| Non-exercise control | Placebo comparator | Participants will not receive any exercise training but will attend 48 recreation workshops. Receives: Behavioral: Non-exercise control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
Bone mineral density at the non-dominant lumbar spine and femoral neck of hip will be measured by one registered technician using DXA (XR-46, Norland, Wisconsin, USA) at an assessment center in the Chinese University of Hong Kong.
Measured: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).
Bone turnover markers
The two bone turnover markers, P1NP (ng/ml) and CTX (ng/L) will be used to assess the subjects' bone formation and bone resorption. Participants must arrive at the elderly center between 08:30 and 09:30 a.m. after a 12-hour overnight fast and avoid intense physical activity the night before. A qualified nurse will collect 5 mL of venous blood from the antecubital vein, which will coagulate at room temperature for 20-30 minutes before being transported to the lab within one hour. The blood will then be centrifuged at 4 °C and 3000 rpm for 50 minutes, with the resulting sample stored at -80 °C for serum biochemical marker assays. Serum P1NP and CTX levels will be measured using ELISA kits from Immunodiagnostic Systems Inc., and analysis will be conducted by the Hong Kong Polytechnic University test lab.
Measured: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).
Secondary outcomes (9)
Physical fitness_Body mass index
BMI (kg/m²) was calculated by dividing weight in kilograms by the square of height in meters. Body weight was measured using a mobile scale that was accurate to 0.01 kg and calibrated before use. Participants were instructed to remain still until the digital display stabilized, at which point their weights were recorded. Height was measured using a mobile stadiometer accurate to 0.1 cm, and participants were asked to stand straight with their knees together during the measurement.
Measured: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).
Physical fitness_Lower limb muscle strength
30-Second Chair Stand will used to assess lower limb muscle strength. The required tools will include a straight-backed chair (43 cm seat height) and a timer. Participants will sit in the middle of the chair with their feet shoulder-width apart, crossing their arms at the wrists close to their chest. They will then stand fully and sit back down, counting this as one movement, which will be repeated for 30 seconds after the initial instruction.
Measured: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).
Physcal fitness_Upper limb muscle strength
30-second Arm Curl will be used to evaluate upper limb muscle strength. This test will measure upper body strength using a 5-pound dumbbell, a chair without armrests, and a timer. Conducted on the stronger arm, participants will curl their arm through a full range of motion, turning the palm upward. They will fully bend and straighten the arm at the elbow, repeating this as many times as possible within 30 seconds.
Measured: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test)
Physical fitness_Aerobic endurance
Aerobic endurance will be measured by a 2-Minute Step Test. A timer will be used for this procedure. Participants will stand straight next to a wall, where a mark will indicate the midpoint between the kneecap and hip bone. They will step for two minutes, lifting their knees to the mark's height.
Measured: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).
Physical fitness_Lower body flexibility
Lower body flexibility will be assessed by a Chair Sit-and-Reach Test. The required tools will include a ruler and a straight-backed chair about 43 cm high. Participants will sit on the edge of the chair, with one foot flat on the floor and the other leg extended forward, keeping the knee straight and the ankle at a 90° angle. They will reach forward toward their toes with overlapping hands, maintaining a straight back and keeping their heads up. The distance from their fingertips to their toes will be measured and held for a moment.
Measured: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).
Physical fitness_Upper body flexibility
Upper body flexibility will be assessed by the Back Scratch Test. The required tool will be a ruler. Participants will place one hand behind their head and over their shoulder, reaching as far as possible with the palm against the body and fingers pointing down. The other arm will be positioned behind the back, with the palm facing outward and fingers pointing up, reaching to overlap the fingertips of both hands. The distance between the tips of the middle fingers will be measured.
Measured: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).
Physical fitness_Mobility and dynamic balance
Mobility and dynamic balance will be measured by the 8-Foot Up-and-Go Test. The required tools will include a timer, a straight-backed chair about 43 cm high, a cone marker, and a measuring tape. The cone will be placed 2.4 m in front of the chair. Participants will start by sitting with their hands on their knees and feet flat on the ground. They will then stand up and walk quickly (without running) to round the cone and return to sit down. The time taken from standing to sitting will be measured.
Measured: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).
Fear of falling
Fear of falling (FOF) will be measured using the Chinese version of the Falls Efficacy Scale-International (FES-I). This scale includes questions adapted from the original 16-item FES-I questionnaire to evaluate FOF during specific daily activities. The total score of the questionnaire ranges from 16 to 64, and a higher score indicates that the individual perceives themselves as having a significant fear of falling, which can lead to reduced activity levels and an increased risk of social isolation. The Chinese version of SFES-I demonstrated good internal consistency and reliability, with a Cronbach's α of 0.88.
Measured: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).
Perceived quality of life
The quality of life will be assessed using the brief version of the Hong Kong Chinese WHO Quality of Life Scale (WHOQOL-BREF) (Cronbach's α = .73 - .84). The scale includes 28 items, covering four dimensions of how older adults perceive their quality of life. The total score of the questionnaire ranges from 28 to 140, and a higher score indicates that the individual feels they have a high quality of life.
Measured: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start16 Oct 2024
- Primary completion28 Feb 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for OsteopeniaStudies 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
- The present research follows a randomized controlled experimental design (RCT), parallel type with two groups in multi-centers, and is assessed in a pretest, posttest, and six months after the completion of the intervention. The participants will be randomly allocated to one experimental group, and one non-exercise control group. The non-exercise control group will be asked to attend a workshop. At the same time, the exercise group performs a HIIT program.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yanping Duan, Principal investigator, Hong Kong Baptist University; Department of Sport, Physical Education and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888544
- Sponsor's protocol ID
- HMRF07220048
- Status last verified
- Dec 2024
- First submitted
- 4 Feb 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chapman, J. J., Coombes, J. S., Brown, W. J., Khan, A., Chamoli, S., Pachana, N. A., & Burton, N. W. (2017). The feasibility and acceptability of high-intensity interval training for adults with mental illness: A pilot study. Mental Health and Physical Activity, 13, 40-48
Grant A, Treweek S, Dreischulte T, Foy R, Guthrie B. Process evaluations for cluster-randomised trials of complex interventions: a proposed framework for design and reporting. Trials. 2013 Jan 12;14:15. doi: 10.1186/1745-6215-14-15.
PubMed 23311722Kwan MM, Tsang WW, Close JC, Lord SR. Development and validation of a Chinese version of the Falls Efficacy Scale International. Arch Gerontol Geriatr. 2013 Jan-Feb;56(1):169-74. doi: 10.1016/j.archger.2012.10.007. Epub 2012 Oct 30.
PubMed 23116978Marriott CFS, Petrella AFM, Marriott ECS, Boa Sorte Silva NC, Petrella RJ. High-Intensity Interval Training in Older Adults: a Scoping Review. Sports Med Open. 2021 Jul 19;7(1):49. doi: 10.1186/s40798-021-00344-4.
PubMed 34279765Carlson SA, Fulton JE, Schoenborn CA, Loustalot F. Trend and prevalence estimates based on the 2008 Physical Activity Guidelines for Americans. Am J Prev Med. 2010 Oct;39(4):305-13. doi: 10.1016/j.amepre.2010.06.006.
PubMed 20837280Zitzmann AL, Shojaa M, Kast S, Kohl M, von Stengel S, Borucki D, Gosch M, Jakob F, Kerschan-Schindl K, Kladny B, Lange U, Middeldorf S, Peters S, Schoene D, Sieber C, Thomasius F, Uder M, Kemmler W. The effect of different training frequency on bone mineral density in older adults. A comparative systematic review and meta-analysis. Bone. 2022 Jan;154:116230. doi: 10.1016/j.bone.2021.116230. Epub 2021 Oct 5.
PubMed 34624560Lin CY, Park JH, Hsueh MC, Sun WJ, Liao Y. Prevalence of Total Physical Activity, Muscle-Strengthening Activities, and Excessive TV Viewing among Older Adults; and Their Association with Sociodemographic Factors. Int J Environ Res Public Health. 2018 Nov 8;15(11):2499. doi: 10.3390/ijerph15112499.
PubMed 30413089Pinheiro MB, Oliveira J, Bauman A, Fairhall N, Kwok W, Sherrington C. Evidence on physical activity and osteoporosis prevention for people aged 65+ years: a systematic review to inform the WHO guidelines on physical activity and sedentary behaviour. Int J Behav Nutr Phys Act. 2020 Nov 26;17(1):150. doi: 10.1186/s12966-020-01040-4.
PubMed 33239014Nguyen VH. Osteoporosis prevention and osteoporosis exercise in community-based public health programs. Osteoporos Sarcopenia. 2017 Mar;3(1):18-31. doi: 10.1016/j.afos.2016.11.004. Epub 2016 Dec 24.
PubMed 30775499
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-Intensity Interval Training on Bone Health, Physical Fitness and Quality of Life in Elderly Women With Osteopenia: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06888544
- Acronym / sponsor ID
- HMRF07220048
- Conditions
- Osteopenia
- Keywords
- Osteopenia, Older women, High-intensity interval training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 21 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.
Osteoporosis is an age-related disease, characterized by a decreased bone mass and an increased risk of fragility fractures. Osteoporosis leads to increasing mortality, disabilities, morbidity of chronic pain, and the cost of health and social care, as well as decreasing the quality of life from reduced independence and hindered physical, mental, and social well-being.
A recent review and meta-analysis, investigating the association between physical activity and osteoporosis prevention in elderly people, indicated that the traditional exercise interventions (i.e., resistance training) were undertaken for 60+ mins, 2-3 times/week for 7+ months. However, participation rates remain low in these exercise programs among older adults, in part due to a need for specialized equipment and correct techniques to prevent injury. In addition, low motivation and associated compliance with such conventional exercise is problematic among older adults.
Considering there is little evidence of HIIT benefits related to older women with osteopenia, the current study aims to evaluate the effectiveness of a 24-week HIIT intervention on bone mineral density, bone turnover markers and other health-related outcomes among Hong Kong Chinese older women.
Detailed description
The study will be a randomized controlled trial (RCT) with two groups and three times repeated measures. Data will be collected in a pretest, post-test, and six months after the intervention. The eligible participants will be randomly distributed into one of two groups in a ratio of 1:1. The participants recruited and meeting the screening criteria will receive a 24-week HIIT intervention or recreation workshop. The intervention effects will be evaluated on bone mineral density, bone turnover markers, physical fitness, fear of falling, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The present research follows a randomized controlled experimental design (RCT), parallel type with two groups in multi-centers, and is assessed in a pretest, posttest, and six months after the completion of the intervention. The participants will be randomly allocated to one experimental group, and one non-exercise control group. The non-exercise control group will be asked to attend a workshop. At the same time, the exercise group performs a HIIT program.
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training (HIIT) | Experimental | Behavioral: HIIT program for 24 weeks with a frequency of 2 times per week.HIIT program for 24 weeks with a frequency of 2 times per week. |
| Non-exercise control | Placebo comparator | Behavioral: Non-exercise controlParticipants will not receive any exercise training but will attend 48 recreation workshops. |
Who may qualify
- Ages
- 60 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • 60 to 74 years at the start date of the project
Key exclusion criteria (6 listed)
- • Severe chronic disease restricting high-intensity exercise
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 |
|---|---|---|
| HIIT program for 24 weeks with a frequency of 2 times per week.Participants will receive a 24-week HIIT program, with 2 sessions per week. Each session will comprise three sections, including warm-up, main exercise and cool down. The time will be between 37 to 40 minutes with progression of training. Each HIIT section will include six high-impact weight-bearing exercise. For Weeks 1-4, the HIIT section will include 12 intervals of 30 seconds HIIT workout at corresponding intensity, separated by 11 intervals of 60 seconds of active recovery. To ensure the subjects' safety, a chair will be used for assistance during training in the first month. Additionally, a 3 kg weight will be incorporated for the training in the final two months. | Behavioural | High-intensity interval training (HIIT) |
| Non-exercise controlWorkshop participants in the non-exercise control group will receive a series of workshops related to daily recreation. | Behavioural | Non-exercise control |
Primary outcome
Bone mineral density
Time frame: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).
Bone mineral density at the non-dominant lumbar spine and femoral neck of hip will be measured by one registered technician using DXA (XR-46, Norland, Wisconsin, USA) at an assessment center in the Chinese University of Hong Kong.
Bone turnover markers
Time frame: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).
The two bone turnover markers, P1NP (ng/ml) and CTX (ng/L) will be used to assess the subjects' bone formation and bone resorption. Participants must arrive at the elderly center between 08:30 and 09:30 a.m. after a 12-hour overnight fast and avoid intense physical activity the night before. A qualified nurse will collect 5 mL of venous blood from the antecubital vein, which will coagulate at room temperature for 20-30 minutes before being transported to the lab within one hour. The blood will then be centrifuged at 4 °C and 3000 rpm for 50 minutes, with the resulting sample stored at -80 °C for serum biochemical marker assays. Serum P1NP and CTX levels will be measured using ELISA kits from Immunodiagnostic Systems Inc., and analysis will be conducted by the Hong Kong Polytechnic University test lab.
9 secondary outcomes
Physical fitness_Body mass index
Time frame: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).
Physical fitness_Lower limb muscle strength
Time frame: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).
Physcal fitness_Upper limb muscle strength
Time frame: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test)
Physical fitness_Aerobic endurance
Time frame: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).
Physical fitness_Lower body flexibility
Time frame: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).
Physical fitness_Upper body flexibility
Time frame: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).
Physical fitness_Mobility and dynamic balance
Time frame: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).
Fear of falling
Time frame: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).
Perceived quality of life
Time frame: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).
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 21 Mar 2025.
- BackgroundChapman, J. J., Coombes, J. S., Brown, W. J., Khan, A., Chamoli, S., Pachana, N. A., & Burton, N. W. (2017). The feasibility and acceptability of high-intensity interval training for adults with mental illness: A pilot study. Mental Health and Physical Activity, 13, 40-48
- Background: PubMed 23311722Grant A, Treweek S, Dreischulte T, Foy R, Guthrie B. Process evaluations for cluster-randomised trials of complex interventions: a proposed framework for design and reporting. Trials. 2013 Jan 12;14:15. doi: 10.1186/1745-6215-14-15.
- Background: PubMed 23116978Kwan MM, Tsang WW, Close JC, Lord SR. Development and validation of a Chinese version of the Falls Efficacy Scale International. Arch Gerontol Geriatr. 2013 Jan-Feb;56(1):169-74. doi: 10.1016/j.archger.2012.10.007. Epub 2012 Oct 30.
- Background: PubMed 34279765Marriott CFS, Petrella AFM, Marriott ECS, Boa Sorte Silva NC, Petrella RJ. High-Intensity Interval Training in Older Adults: a Scoping Review. Sports Med Open. 2021 Jul 19;7(1):49. doi: 10.1186/s40798-021-00344-4.
- Background: PubMed 20837280Carlson SA, Fulton JE, Schoenborn CA, Loustalot F. Trend and prevalence estimates based on the 2008 Physical Activity Guidelines for Americans. Am J Prev Med. 2010 Oct;39(4):305-13. doi: 10.1016/j.amepre.2010.06.006.
- Background: PubMed 34624560Zitzmann AL, Shojaa M, Kast S, Kohl M, von Stengel S, Borucki D, Gosch M, Jakob F, Kerschan-Schindl K, Kladny B, Lange U, Middeldorf S, Peters S, Schoene D, Sieber C, Thomasius F, Uder M, Kemmler W. The effect of different training frequency on bone mineral density in older adults. A comparative systematic review and meta-analysis. Bone. 2022 Jan;154:116230. doi: 10.1016/j.bone.2021.116230. Epub 2021 Oct 5.
- Background: PubMed 30413089Lin CY, Park JH, Hsueh MC, Sun WJ, Liao Y. Prevalence of Total Physical Activity, Muscle-Strengthening Activities, and Excessive TV Viewing among Older Adults; and Their Association with Sociodemographic Factors. Int J Environ Res Public Health. 2018 Nov 8;15(11):2499. doi: 10.3390/ijerph15112499.
- Background: PubMed 33239014Pinheiro MB, Oliveira J, Bauman A, Fairhall N, Kwok W, Sherrington C. Evidence on physical activity and osteoporosis prevention for people aged 65+ years: a systematic review to inform the WHO guidelines on physical activity and sedentary behaviour. Int J Behav Nutr Phys Act. 2020 Nov 26;17(1):150. doi: 10.1186/s12966-020-01040-4.
- Background: PubMed 30775499Nguyen VH. Osteoporosis prevention and osteoporosis exercise in community-based public health programs. Osteoporos Sarcopenia. 2017 Mar;3(1):18-31. doi: 10.1016/j.afos.2016.11.004. Epub 2016 Dec 24.
- Individual participant dataSharing planned: No
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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.
Yanping Duan principal investigator
Hong Kong Baptist University; Department of Sport, Physical Education and Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT program for 24 weeks with a frequency of 2 times per week. in people with Osteopenia, run by Hong Kong Baptist University 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 7 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 21 Mar 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. Some participants in this study may receive a placebo. 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 Yanping Duan (34115638, duanyp@hkbu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (time frame: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).). The study lists 2 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 NCT06888544, which also lists 9 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 21 Mar 2025.