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 |
| Protocol serial number | N/A |
| Sponsor | Razi University (Iran) |
| Funder | Razi University (Iran) |
- 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
Scientific
Iranian Institute for Health Sciences Research
P.O. Box 13185-1488
Tehran
-
Iran
| Phone | +98 (0)21 66480804 |
|---|---|
| montazeri@acecr.ac.ir |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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). |
| Key secondary outcome measure(s) |
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). |
| Completion date | 01/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 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
-
Iran
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
