Condition category
Nervous System Diseases
Date applied
10/07/2008
Date assigned
21/07/2008
Last edited
20/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ali Montazeri

ORCID ID

Contact details

Iranian Institute for Health Sciences Research
P.O. Box 13185-1488
Tehran
-
Iran
+98 (0)21 66480804
montazeri@acecr.ac.ir

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

QOLADLPD

Study hypothesis

Physical therapy would be effective in improving quality of life and activity of daily living in patients with Parkinson's disease.

Ethics approval

Ethics approval received from the Ethics Committee of Razi University in December 2006.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/01/2007

Overall trial end date

01/12/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

24

Participant exclusion criteria

Does not comply with the above inclusion criteria

Recruitment start date

01/01/2007

Recruitment end date

01/12/2007

Locations

Countries of recruitment

Iran

Trial participating centre

Iranian Institute for Health Sciences Research
Tehran
-
Iran

Sponsor information

Organisation

Razi University (Iran)

Sponsor details

Faculty of Physical Education
Kermanshah
-
Iran
+98 (0)831 4279265
info@razi.ac.ir

Sponsor type

University/education

Website

http://www.razi.ac.ir/

Funders

Funder type

University/education

Funder name

Razi University (Iran)

Alternative name(s)

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Iran

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19671145

Publication citations

  1. Results

    Yousefi B, Tadibi V, Khoei AF, Montazeri A, Exercise therapy, quality of life, and activities of daily living in patients with Parkinson disease: a small scale quasi-randomised trial., Trials, 2009, 10, 67, doi: 10.1186/1745-6215-10-67.

Additional files

Editorial Notes