Randomised controlled trial of a home-based exercise programme to reduce fall frequency among people with Parkinson's disease (PD)
| ISRCTN | ISRCTN63503875 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63503875 |
| Protocol serial number | AP0888 |
| Sponsor | Action Medical Research (UK) |
| Funder | Action Medical Research (UK) |
- Submission date
- 08/12/2003
- Registration date
- 05/01/2004
- Last edited
- 21/01/2009
- 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 Ann Ashburn
Scientific
Scientific
Health & Rehabilitation Research Unit
Level E, Centre Block, Mail Point 886
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)2380 796 469 |
|---|---|
| a.m.ashburn@soton.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To evaluate the effectiveness of a personalised home programme of exercises and strategies for repeat fallers with Parkinson's disease (PD). |
| Ethics approval(s) | East Dorset Local Research Ethics Committee gave approval in March 2001 (ref: 13/00/S) |
| Health condition(s) or problem(s) studied | Parkinson's disease |
| Intervention | Intervention: A home-based exercise programme, supervised by a physiotherapist. Appropriate exercises will be chosen from a menu of: 1. Balance training exercises in sitting and standing 2. Stretches 3. A programme of walking and moderate intensity strengthening exercises for hip, knee and ankle 4. Control: Usual care. |
| Intervention type | Other |
| Primary outcome measure(s) |
Rates of falling at 8 weeks and 6 months. |
| Key secondary outcome measure(s) |
1. Repeat fallen, nearly fallen or experienced injurious falls |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 140 |
| Key inclusion criteria | 1. Diagnosed with PD living in the community 2. Independently mobile 3. Have experienced two or more falls in the previous 12 months 4. Have passed a screen test for confusion 5. Aged 44 - 91 years, both sexes |
| Key exclusion criteria | 1. Did not meet inclusion criteria 2. Unable to participate in assessments because of pain and acute medical condition 3. In receipt of, or soon to receive, treatment |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Health & Rehabilitation Research Unit,
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2007 | Yes | No |
