Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00473

2 Trial Registration Date

2015-08-28

i Registration Status

Prospective

3 Secondary IDs

NTWC/CREC/15087

4 Source(s) of Funding

Physiotherapy Department

5 Primary Sponsor

Tuen Mun Hospital

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Leung Wan Chi

ii Address

Tuen Mun Hospital

iii Phone

2468 5216

iv Email

lwc652@ha.org.hk

v Affiliation

Physiotherapy Department, Tuen Mun Hospital

vi Country

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

i Name

Lee Yin Tak

ii Address

Tuen Mun Hospital

iii Phone

2468 5216

iv Email

lyt849@ha.org.hk

v Affiliation

Physiotherapy Department, Tuen Mun Hospital

vi Country

9 Official Scientific Title of the Study

Effects of exercise training on the fatigue level, physical fitness and functional performance in prostate cancer survivors: A randomized control study

10 Public Title

Effects of exercise training on the fatigue level, physical fitness and functional performance in prostate cancer survivors: A randomized control study

i Public Title in Chinese 研究名稱

運動訓練對改善前列腺癌康復者之疲倦、肌肉力量、耐力及生活質素的效益

11 Short Title (Optional)

Exercise management for cancer

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?

2015-08-24

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Cancer

15 Intervention

i Types of intervention

Other

Please specify

Exercise

ii Description/ name of Intervention/article

Exercise training program

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Exercise training program once per week for 2 months (total of 8 sessions). Each session will last f

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

The exercise program was specifically designed by physiotherapists including the components of warm up, stretching, aerobic, strengthening, core stabilization, pelvic floor training and cool down.

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

Diagnosis of localized prostate cancer
No regular exercise (undertaking structured aerobic or resistance training less than two times per week) within the past 6 months
Ambulatory without aid and able to complete self-report measures

ii Exclusion Criteria

Major health problems (uncontrolled hypertension, i.e., seated systolic blood pressure >160mmHg or seated diastolic blood pressure >90mmHg, uncontrolled insulin-dependent diabetes mellitus, severe arthritis, and obvious cognitive dysfunction)
Recent history of sudden onset of shortness of breath on exertion or a recent history of dizziness, blurred vision, or fainting spells
Recent history of unstable angina, coronary artery disease, myocardial infarction, or cardiac failure
Bone, back, or neck pain of recent onset, or inability to exercise

iii Age Minimum

18

iv Age Maximum

100

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2015-09-30

21 Target Sample Size

48

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

1. Fatigue level with numeric rating scale with 0-10
2. Resting BP/P
3. Handgrip & Quadriceps strength
4. 30 second sit to stand test
5. Functional reach in standing
6. Personal Wellbeing Index
7. Urinary incontinence questionnaires

24 Secondary Outcome

N/A

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-04-05

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2015-08-28