Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00522

2 Trial Registration Date

2016-08-19

iRegistration Status

Prospective

3 Secondary IDs

2016.323-T

4 Source(s) of Funding

N/A

5 Primary Sponsor

The Nethersole School of Nursing

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

JoJo Kwok

ii Address

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

iii Phone

852-39434430

iv Email

jojokwok@link.cuhk.edu.hk

v Affiliation

The Nethersole School of Nursing, The Chinese Univeristy of Hong Kong

vi Country

Hong Kong SAR

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

i Name

Yan Yan Kwok

ii Address

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

iii Phone

852-39434430

iv Email

jojokwok@link.cuhk.edu.hk

v Affiliation

The Nethersole School of Nursing, The Chinese Univeristy of Hong Kong

vi Country

Hong Kong SAR

9 Official Scientific Title of the Study

The effect of yoga on psychological distress for people with Parkinson's disease: a randomized controled trial

10 Public Title

Exercise programme to enhance the physical and psychological wellbeing for people with Parkinson's disease

i Public Title in Chinese 研究名稱

探討有效改善柏金遜症患者身心健康的方法

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2016-07-27

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2016.323-T

14 Medical Condition Being Studied

People with Parkinson's disease

15Intervention

i Types of intervention

Other

Please specify

Yoga

ii Description/ name of Intervention/article

Twelve basic Hatha yoga poses (sun salutations)

iii Dosage form of the intervention

Yoga training class

iv Dosage of the intervention

60-minute per session, once a week

v Duration of the intervention

Eight weeks

vi Frequency of the intervention

Once a week for eight weeks, self practice for 20-minute twice a week

16Comparative Treatments

i Description/ name of comparative treatments

Stretching and resistance training

ii Dosage form of the comparative treatments

stretching and resistance training class

iii Dosage of the comparative treatments

60-minute per session, once a week

iv Duration of the comparative treatments

Eight weeks

v Frequency of the comparative treatments

Once a week for eight weeks, self practice for 20-minute twice a week

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1. a clinical diagnosis of PD, with a disease severity rating of stage I to III on the Hoehn and Yahr scale;

2. age above 18 years old

3. stable medication usage within recent three months

4. ability to stand unaided or walk with or without an assistive device

ii Exclusion Criteria

1. participants who are currently receiving treatment for mental disorders or with uncontrolled mood disorders

2. current participation in any other behavioural or pharmacological trial or instructor-led exercise programme

3. the Abbreviated Mental Test lower than 6

4. other debilitating conditions except PD, e.g. cognition or vision impairment, that would impede full participation in the study

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19Study Design

i Randomization

Randomized

Please specify

Permuted block randomization (Computer generated random numbers for block sizes)

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Investigator/research team

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

N/A

vi Study Objectives (Optional)

20 Anticipated trial start date

2016-09-01

21 Target Sample Size

160

22 Recruitment Status

Not Yet Recruiting

23Primary Outcome

iThe Name of the outcome

Psychological distress

iiThe metric or method of measurement used

Questionnaire