Clinical trial NCT06888544: Effects of High-Intensity Interval Training on Bone Health in Hong Kong Older Women
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteopenia
Keywords: Osteopenia
Older women
High-intensity interval training
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 48
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* • 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

Exclusion Criteria:

* • 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.

Primary outcomes:
measure: Bone mineral density
timeFrame: 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).
measure: Bone turnover markers
timeFrame: 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:
measure: Physical fitness_Body mass index
timeFrame: 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).
measure: Physical fitness_Lower limb muscle strength
timeFrame: 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).
measure: Physcal fitness_Upper limb muscle strength
timeFrame: 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)
measure: Physical fitness_Aerobic endurance
timeFrame: 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).
measure: Physical fitness_Lower body flexibility
timeFrame: 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).
measure: Physical fitness_Upper body flexibility
timeFrame: 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).
measure: Physical fitness_Mobility and dynamic balance
timeFrame: 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).
measure: Fear of falling
timeFrame: 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).
measure: Perceived quality of life
timeFrame: 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).
Other outcomes:
measure: Heart rate
timeFrame: Heart rate will be monitored from the start of warm-up to the end of cool-down at each exercise session during the 24-weeks exercise intervention.
measure: Self-reported Rate of Perceived Exertion (RPE)
timeFrame: RPE will be asked at the end of main exercise at each exercise session during the 24-weeks intervention
measure: Safety: adverse events
timeFrame: Adverse events will be asked at the end of each exercise session during the 24-weeks intervention program
measure: Exercise acceptability
timeFrame: The exercise acceptability will be evaluated after 24 weeks of intervention.
measure: Process evaluation of intervention program
timeFrame: Outcome evaluations will be conducted at the completion of 24-weeks intervention
measure: Retention rate
timeFrame: 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).
measure: Session attendance rate
timeFrame: Session attendance will be recorded during the 24-week intervention
Locations:
city: China
country: China
facility: Bliss District Elderly Community Centre
state: Hong Kong
Study officials:
affiliation: Hong Kong Baptist University; Department of Sport, Physical Education and Health
name: Yanping Duan
role: PRINCIPAL_INVESTIGATOR
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