Prospective

Song Dan

Rm 601, Esther Lee Building, the Nethersole School of Nursing, the Chinese University of Hong Kong

39439307

songdan@link.cuhk.edu.hk

The Nethersole School of Nursing, the Chinese University of Hong Kong

China

Song Dan

Rm 601, Esther Lee Building, the Nethersole School of Nursing, the Chinese University of Hong Kong

39439307

songdan@link.cuhk.edu.hk

The Nethersole School of Nursing, the Chinese University of Hong Kong

China

評估踏板運動對提高輕度認知障礙患者認知功能、改善抑鬱及生活質量的效果研究

Yes

2016-09-19

Joint CUHK-NTEC Clinical Research Ethics Committee

2016.287-T

Other

moderate-intensity aerobic stepping exercise

The proposed exercise intervention is a supervised, group-format, moderate- intensity aerobic stepping exercise located on the indoor area in the community healthcare center. The program is consistent with the current guidelines of exercises for the older adults which recommend at least 150 minutes moderate-intensity aerobic exercise per week . The program will be implemented three sessions per week, 60 minutes per session. Each session starts with a 10-minute warm-up period using self-paced walking and static stretching from head to toe, and followed by a session of moderate-intensity stepping exercise. The stepping exercise involves step-on and step-off using a 10–cm high step bench; the bench is specifically designed for stepping exercise which is stable, skid-proof and has a bearing capacity of 200 kilograms; the height of 10 cm is chosen because bench height is associated with mechanical load and this 10 cm high bench can reduce the risks of injury for the beginners and is suitable for elderly who are less physically active or have reduced joint flexibility . Upper limb movement will be added concurrently to facilitate overall body exercise. To enhance adherence and avoid injury risks, the exercise program will be introduced in a progressive manner with the duration gradually increasing from 20 minutes to the targeted 40 minutes in four weeks’ time. Subjects will perform the bench stepping exercise in multiple bouts of at least 10 minutes each rather than in a single continuous bout to reach the targeted duration . Moderate-intensity exercise will be monitored by a combination of the Borg Rate of Perceived Exertion (Borg RPE) and talk test. Borg RPE is a 15-point scale with scores ranging from 6-20, with higher scores indicating more perceived exertion. Physical activity that results in a rating of 12-14 (descriptor: “somewhat hard”) on the Borg RPE is identified as reaching a moderate intensity. The investigator will explain the Borg RPE scale to the subjects and instruct them to adjust their pace in order to achieve a feeling of ‘somewhat hard’ at the Borg RPE rating of 12-14. In addition to the Borg RPE, talk test will also be employed to monitor exercise intensity, by which subjects being able to talk with some slight effort during the training indicates that the intensity is appropriate, if talking is very difficult, the intensity would be too high. RPE combined with the talk test is recommended as effective and practical method to monitor aerobic intensity. The training session will end with a 10-minute cool down session with self-paced walking and static stretching. Vital signs including heart rate and blood pressure will be assessed before and after the training to detect those abnormal subjects for safety sake . Attendance and adverse events will be recorded. The PI (Register Nurse) and staff in the community healthcare center will manage any adverse events.

16-week program, with three 60-minute group sessions (group size: around 10) per week

16-week program, with three 60-minute group sessions (group size: around 10) per week

16 weeks

3 sessions/ week for 16 weeks

In order to enhance the internal validity of the study findings, an attention placebo will be administered to the participants in the control group to allow for a placebo effect. Control groups subjects will receive eight bi-weekly health education classes, which lasted about 45-60 minutes per session. The topics of education classes include health preservation of traditional Chinese medicine, self-management of chronic illness, fall prevention, oral health, skin health, constipation management, pain management, and cataract.

bi-weekly session for 16 weeks

eight 60-minute education sessions, once for two weeks

16 weeks

bi-weekly for 16 weeks

Chinese older adults aged over 60

individuals who are able to communicate

individuals who are detected with MCI. Diagnosis based on the criteria recommended by the international working group on Mild Cognitive Impairment

individuals who have a diagnosed psychiatric condition at enrollment except depression

individual who are taking anti-depressant agent which confounds the psychological outcomes

individuals who have severe neurological disorders(e.g. stroke, Parkinson's disease)

individuals who have contraindications to exercise training, including myocardial infarction or cardiac surgery within six months, unstable angina, uncontrolled arrhythmia, acute congestive heart failure, third degree heart block, and uncontrolled diabetes mellitus

individuals who have acute exacerbation of osteoarthritis

individuals who have impaired hearing or vision which hinders them from answering the questionnaires

individuals who have malignant conditions, such as cancer and HIV, which may be associated with response bias

individuals who have regular participation in more than 150 minutes /week of planned exercise of any kind

60

999

Both Male and Female

Randomized

Block randomisation with a block size of 20

Active

Single-blind

Investigator/research team

Parallel

1

To determine the effects of moderate-intensity stepping exercise program on cognitive function, depressive symptoms and health-related quality of life in MCI patients.

No