Objectives: The purpose of this study is to evaluate the effect of physical and psychological intervention on quality of sleep and quality of life in people with Parkinson aged 45 to 70 years old. Design: Participants are selected from people with parkinson in hospitals and occupational Therapy clinics in Tehran. 40 participants are randomly assigned into control or intervention group by coded envelop. Setting and conduct: Evaluations are done two times before and after the intervention by a trained Occupational Therapist who is blind to type of group. Participants: Subjects must be in level 1 to 4 from Hoehn and Yahr Scale. Intervention: After the baseline assessments, treatment sessions are given for 6 weeks. Each session of Treatment includes: physical and psychological interventions. Main outcome measures: Parkinson's disease sleep scale (PDSS), Parkinson's Disease Questionnaire (PDQ), Depression and Anxiety and Stress (DASS) and Goniometry for shoulder, hip, knee, and ankle joints.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201710083551N7
Registration date:2017-10-09, 1396/07/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-09, 1396/07/17
Registrant information
Name
Parvin Raji
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 8798
Email address
praji@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for education,Tehran University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of physical and psychological intervention on quality of sleep and quality of life
in people with Parkinson
Public title
The effect of physical and psychological intervention on quality of sleep and quality of life
in people with Parkinson
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: The age range is 45-70 years; Having Level 1-4 by Hoehn and Yahr Scale; Having a sleep disorder using the PDSS score test (score less than 71); not having severe depression (score less than 29) based on Beck depression inventory; Having a cognitive level above 24 in MMSE exam; Do not take sleep medications; absence of other diseases (cardiovascular disorders, other orthopedic and neurological disorders, etc.). Exclusion criteria: Lack of patient collaboration; Failure to go on time for tests.
Age
From 45 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Poursina St, Ghods St, Keshavarz Blvd