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

NCT06888544 | Recruiting

• 1 other identifier: HMRF07220048
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteopenia

Keywords

Osteopenia; Older women; High-intensity interval training

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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

  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

  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

  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 (7)

• Heart rate

  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.

• Self-reported Rate of Perceived Exertion (RPE)

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

• Safety: adverse events

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

Study Arms (2)

High-intensity interval training (HIIT)

EXPERIMENTAL

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

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.

Behavioral: Non-exercise control

Interventions

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.

High-intensity interval training (HIIT)

Non-exercise control BEHAVIORAL

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

Non-exercise control

Eligibility Criteria

• Age: 60 Years - 74 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hong Kong Baptist University: lead

Study Sites (1)

Bliss District Elderly Community Centre

China, Hong Kong, 999077, China

RECRUITING

Related Publications (9)

• 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

  BACKGROUND

• 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.

  PMID: 23311722 BACKGROUND

• Kwan 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.

  PMID: 23116978 BACKGROUND

• Marriott 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.

  PMID: 34279765 BACKGROUND

• Carlson 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.

  PMID: 20837280 BACKGROUND

• Zitzmann 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.

  PMID: 34624560 BACKGROUND

• Lin 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.

  PMID: 30413089 BACKGROUND

• Pinheiro 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.

  PMID: 33239014 BACKGROUND

• Nguyen 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.

  PMID: 30775499 BACKGROUND

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Yanping Duan

  Hong Kong Baptist University; Department of Sport, Physical Education and Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanping Duan

CONTACT

34115638; duanyp@hkbu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: March 21, 2025
• Study Start: October 16, 2024
• Primary Completion: February 28, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: March 21, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)