Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06124456 |
| Other study ID # |
HKU-NFI |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2024 |
| Est. completion date |
January 2027 |
Study information
| Verified date |
December 2023 |
| Source |
The University of Hong Kong |
| Contact |
Parco M Siu, PhD |
| Phone |
28315262 |
| Email |
pmsiu[@]hku.hk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Non-alcoholic fatty liver disease (NAFLD) arising from obesity has become a global health
concern. Although exercise is a cornerstone approach for managing NAFLD, detailed exercise
prescription guidelines are unavailable. According to World Health Organization (WHO)
recommendations, 1 minute of vigorous-intensity physical activity can achieve equivalent
health benefits to 2 minutes of moderate-intensity physical activity. It is not known whether
this relationship is applicable to exercise prescribed as an adjunct therapy in NAFLD
treatment. The answer has public health implications because people living with NAFLD can
potentially opt for safe higher-intensity exercise requiring less of a time commitment,
whereas those in older age groups or with comorbidities, for whom vigorous exercise is
unsuitable, can adopt a moderate-intensity regimen of longer duration to acquire equivalent
therapeutic outcomes. Adults with obesity and NAFLD will be randomly allocated to a
supervised vigorous- or moderate-intensity walking group or usual care control group. Each
exercise group will receive a 16-week intervention comprising three walking sessions weekly,
whereas the usual care group will receive general health education as the attention control.
The per-session walking time will be 25 minutes for the vigorous group and 50 minutes for the
moderate group, equating to the same weekly exercise volume and caloric expenditure for each
group according to the WHO's minimum physical activity recommendation. Outcome measures,
including liver fat, visceral and body fat, body anthropometry, intervention adherence,
psychological measures, health-related quality of life, medication usage, adverse events,
habitual physical activity, and diet, will be examined by assessors blinded to the group
allocation at baseline, 16 weeks (post-intervention), and 42 weeks (26-week post-intervention
follow-up). Data will be analyzed by generalized estimating equations and linear contrasts.
The proposed study will provide evidence on the presumed equivalent benefits of vigorous- and
moderate-intensity exercise, with a follow-up period allowing assessment of the efficacy,
safety, adherence, and sustainability of each. The findings will inform practitioners of the
role of exercise intensity in reducing liver fat and refine the exercise guidelines for NAFLD
patients.
Description:
Non-alcoholic fatty liver disease (NAFLD) arising from obesity has become a global health
concern. As well as being a risk factor for cardiovascular disease, diabetes, and chronic
kidney disease, it has also been identified as a precursor to severe liver disease. Given
that there is no available licensed drug for the treatment of NAFLD, the proposed research
seeks to contribute to the treatment and management of NAFLD by comparing two walking
exercise regimens as a lifestyle intervention. Using a robust randomized controlled
equivalence trial design, it will seek an answer to this research question: Does
vigorous-intensity exercise induce equivalent benefits in reducing liver fat relative to
moderate-intensity exercise at matched weekly exercise volumes aligned with the World Health
Organization's (WHO) minimum physical activity recommendation, and can the two regimens
improve NAFLD to a similar degree? Our results are expected to provide scientific
evidence-based conclusions revealing the optimal exercise intensity for NAFLD treatment in
patients with obesity. The proposed study is novel, with worldwide implications for NAFLD
management. The walking programs will be delivered in accordance with the WHO's minimal
physical activity recommendations, thereby putting into practice the standardized WHO
physical activity guidelines, even for unfit beginners for whom minimal exercise is a more
feasible goal. The project thus has two objectives:
1. To examine the therapeutic efficacy of a walking exercise intervention, at either
moderate- or vigorous-intensity, for reducing liver fat in adults with obesity and
NAFLD. The two exercise intensities to be tested are based on the operational definition
of the WHO, and the weekly exercise volumes are aligned with the WHO's minimum physical
activity recommendation.
It is important to elucidate the practical value of the therapeutic efficacy of the
walking exercise intervention, at either moderate- or vigorous-intensity, because
inactive patients with obesity begin exercise training programs with lower, more
achievable goals to learn how to train safely and then adapt progressively, thereby
building a sense of self-efficacy and self-confidence to continue adherence. Hence, the
proposed research has practical value, as it will provide research evidence on the WHO's
minimum exercise guidelines, ultimately contributing to the management and treatment of
NAFLD among obese adults.
2. To compare the equivalence of the head-to-head therapeutic efficacy of
moderate-intensity exercise versus vigorous-intensity exercise with matched weekly
exercise volumes for reducing liver fat in adults with obesity and NAFLD.
This study has important scientific and practical value because it will address an unanswered
scientific question: Does vigorous-intensity exercise induce equivalent benefits for reducing
liver fat in comparison with moderate-intensity exercise at matched weekly exercise volumes?
Its findings will be of practical public health significance to people living with obesity
and NAFLD, as they will have the option to engage in vigorous-intensity exercise for a
shorter duration or moderate-intensity exercise for a longer duration, following the WHO's
physical activity recommendation (75 minutes of vigorous-intensity or 150 minutes of
moderate-intensity exercise weekly). This flexibility aligns with the concept of
"personalized medicine" and is likely to facilitate patient adherence to an exercise program.
If the results show a moderate-intensity exercise regimen with a longer per-session exercise
duration to demonstrate an equivalent therapeutic response, the study will also be of
important clinical value, especially for patients in older age groups or those with
comorbidities, who may be frail and unable to participate in vigorous-intensity exercise. The
proposed research is thus expected to provide new evidence to refine the exercise guidelines
for NAFLD patients, thereby guiding these patients and their healthcare professionals as to
the intensity of weekly exercise that is most suited to their personal circumstances and
lifestyles.
The investigators will test two hypotheses: 1) a 16-week moderate- or vigorous-intensity
walking intervention, when delivered at the minimum amount of physical activity recommended
by the WHO, significantly reduces liver fat in adults with obesity and NAFLD compared with a
usual care control group (to be tested through designed superiority comparisons between the
moderate/vigorous groups and control group), and 2) the therapeutic efficacy of
vigorous-intensity exercise for reducing liver fat is equivalent to that of
moderate-intensity exercise at matched weekly exercise volumes (i.e., 75 minutes of
vigorous-intensity physical activity versus 150 minutes of moderate-intensity physical
activity weekly) (to be tested through designed equivalence comparison between the vigorous
and moderate groups).
