Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00375

2 Trial Registration Date

2013-07-24

i Registration Status

Prospective

3 Secondary IDs

CRE-2013.358-T

4 Source(s) of Funding

Nil/ a self funded study

5 Primary Sponsor

Dr. CHEUNG Lap Kei, the principal investigator, who is a resident in the Department of Psychiatry, Tai Po Hospital

6 Secondary Sponsor

N/A

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Dr. CHEUNG LAP KEI

ii Address

Department of Psychiatry, Tai Po Hospital, 9 Chuen On Road, Tai Po, Hong Kong

iii Phone

26076111

iv Email

clk965@ha.org.hk

v Affiliation

Tai Po Hospital

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Dr. CHEUNG LAP KEI

ii Address

Department of Psychiatry, Tai Po Hospital, 9 Chuen On Road, Tai Po, Hong Kong

iii Phone

26076111

iv Email

clk965@ha.org.hk

v Affiliation

Tai Po Hospital

vi Country

9 Official Scientific Title of the Study

A controlled study of the benefits of an aerobic exercise programme in psychiatric outpatients on treatment for depression in Hong Kong

10 Public Title

A study on aerobic exercise as treatment for depression

i Public Title in Chinese 研究名稱

運動對治療抑鬱症之學術研究

11 Short Title (Optional)

A study on aerobic exercise as adjunct treatment for depression

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2013-07-18

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Depression

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

An aerobic exercise programme consists of jogging, fast walking and cycling, as adjunct treatment to treatment as usual

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

12 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Treatment as usual in the psychiatric outpatient clinics

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

patients with major depressive disorder as diagnosed by the Structured Clinical Interview for DSM-IV with the Hamilton Depression Rating Scale score >= 14 and self reported to be physically inactive at the time of the study (with <2 times of exercise per week)

ii Exclusion Criteria

Patients will be excluded if they are 1) suffering from depressive symptoms in other mental illnesses e.g. bipolar affective disorder, psychotic disorders including schizophrenia and schizoaffective disorder, and obsessive-compulsive disorder, 2) taking substance(s), and 3) suffering from physical conditions that prevent them from doing jogging, cycling or brisk walking. These conditions include untreated hypertension, ischaemic heart disease, cardiomyopathy, arrhythmia, moderate to severe respiratory diseases, history of cerebrovascular accident, severe liver and renal problems, musculoskeletal conditions that hinder the patients from doing aerobic exercise, and any other physical condition or severity of a physical condition that in the opinion of the patient’s physician or the principal investigator that the patient is unfit to participate in the exercise programme. And for women, patients who are currently pregnant or who plan to get pregnant in the next 3 months will also be excluded.

iii Age Minimum

18

iv Age Maximum

65

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2013-08-15

21 Target Sample Size

60

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Depression severity to be measured at baseline and 12 weeks by Hamilton Depression Rating Scale.

24 Secondary Outcome

Secondary outcome measures will assess somatic distress (by PHQ-15), anxiety (by STAI), quality of life (by SF-36), sleep quality (by Pittsburg Sleep Quality Index), certain cognitive performance (the Trail-making test, the Hong Kong List Learning Test, and the verbal fluency test) and body composition (body weight and waist circumference). All measures will be performed at baseline and 12 weeks after randomization.
For the intervention group, the Hospital Anxiety and Depression Scale and PHQ-15 will be administered weekly during the intervention session.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-06-18

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-13003358

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

No

ii Link to Recruitment Information

not available

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Trial History Detail on 2013-08-05