Physical therapy, Quality Of Life, and Activity of Daily Living in patients with Parkinson's Disease: a randomised trial

ISRCTN	ISRCTN98825027
DOI	https://doi.org/10.1186/ISRCTN98825027
Secondary identifying numbers	N/A

Submission date: 10/07/2008
Registration date: 21/07/2008
Last edited: 20/08/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Ali Montazeri
Scientific

Iranian Institute for Health Sciences Research
P.O. Box 13185-1488
Tehran
-
Iran

Phone	+98 (0)21 66480804
Email	montazeri@acecr.ac.ir

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Quality of life
Scientific title
Study acronym	QOLADLPD
Study objectives	Physical therapy would be effective in improving quality of life and activity of daily living in patients with Parkinson's disease.
Ethics approval(s)	Ethics approval received from the Ethics Committee of Razi University in December 2006.
Health condition(s) or problem(s) studied	Parkinson's disease
Intervention	After randomisation, both groups continued to receive their routine pharmacological treatment. The pharmacological treatment for both groups were the same. The intervention group received physical therapy. The physical therapy duration was 10 weeks. Patients in intervention group came to the clinic 4 days a week. Each physical therapy session lasted 1 hour beginning with 10 minutes warm-up, and 45 minutes postural, stretching, and strengthening exercises recommended for PD patients. The session was ended with 5 minutes relaxation and breathing training.
Intervention type	Other
Primary outcome measure	Quality of life (QOL) measured using the Parkinson's Disease Quality of Life (PDQL) questionnaire at baseline (after randomisation) and follow-up (after physical therapy - 12 weeks after randomisation).
Secondary outcome measures	Activity of Daily Living (ADL) measured using the ADL subscale of the Short Parkinson's Evaluation Scale/Scales for Outcomes in Parkinson's disease (SPES/SCOPA) at baseline (after randomisation) and follow-up (after physical therapy - 12 weeks after randomisation).
Overall study start date	01/01/2007
Completion date	01/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	24
Key inclusion criteria	1. Confirmed diagnosis of Parkinson's disease 2. Aged equal to or less than 65 years (male only) 3. Stage 2 or 3 Hoehn and Yahr scale 4. No cardiovascular, orthopaedic or other neurological disease 5. No cognitive impairment
Key exclusion criteria	Does not comply with the above inclusion criteria
Date of first enrolment	01/01/2007
Date of final enrolment	01/12/2007

Locations

Countries of recruitment

Iran

Study participating centre

Iranian Institute for Health Sciences Research

Tehran
-
Iran

Sponsor information

Razi University (Iran)
University/education

Faculty of Physical Education
Kermanshah
-
Iran

Phone	+98 (0)831 4279265
Email	info@razi.ac.ir
Website	http://www.razi.ac.ir/
"ROR"	https://ror.org/02ynb0474

Funders

Funder type

University/education

Razi University (Iran)
Government organisation / Local government

Location: Iran

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	11/08/2009		Yes	No