Effects of High-Intensity Interval Training on Bone Health in Hong Kong Older Women

ConditionOsteopenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age60-74
SponsorHong Kong Baptist University

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

• 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

Disqualifiers

• 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

Trial design

Design model

Parallel

Treatments tested in this trial

  • HIIT program for 24 weeks with a frequency of 2 times per week.

    Behavioral

    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 control

    Behavioral

    Workshop participants in the non-exercise control group will receive a series of workshops related to daily recreation.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: High-intensity interval training (HIIT)Experimental treatment 1 intervention
Group B: Non-exercise controlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

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).
2

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.

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).

Secondary outcomes

1

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.

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).
2

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.

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).
3

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.

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)
4

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.

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).

Other outcomes

1

Heart rate

Participants will be monitored by Polar verity sensor during exercise and their heart rate will be monitored to ensure their safety and intensity adherence of exercise protocol.

Time frame
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.
2

Self-reported Rate of Perceived Exertion (RPE)

Older women will be asked about the self-reported Rate of Perceived Exertion (RPE Borg CR-10 category scale) after they complete the main exercise training in each session. A higher score (closer to 10) means the individual feels they are working much harder, while a lower score (closer to 0) suggests a much easier level of activity.

Time frame
RPE will be asked at the end of main exercise at each exercise session during the 24-weeks intervention
3

Safety: adverse events

All adverse events will be recorded as safety endpoints.

Time frame
Adverse events will be asked at the end of each exercise session during the 24-weeks intervention program
4

Exercise acceptability

Exercise acceptability will be assessed post-intervention using ten questionnaire items responding to a 5-point Likert scale (strongly disagree, disagree, neither agree nor disagree, agree, and strongly agree). The score on this scale ranges from 9 to 40, the higher score shows better acceptability to the exercise intervention.

Time frame
The exercise acceptability will be evaluated after 24 weeks of intervention.

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Bliss District Elderly Community CentreRecruiting999077, China, Hong KongChinaChina

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