Topic: Neurological disorders
Conditions
Interventions
Participants will be randomly allocated to either group 1 (immediate start intervention) or group 2 (delayed start to intervention), with stratification to ensure groups are broadly matched for age an
Sponsors
Northumbria Healthcare NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or over 2. Idiopathic Parkinson’s disease by the UK PD Society Brain Bank Criteria 3. Hoehn and Yahr Stage IIII 4. Ability to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Have been enrolled in a study of an exercise intervention in the last 12 months 2. Other forms of Parkinsonism, e.g. drug induced, 3. Significant medical conditions which would preclude cardiac or lung function testing, 4. Significant medical comorbidity which would preclude exercise or cardiac and lung function testing (e.g. recent blood clot, deep vein thrombosis, pulmonary embolism or myocardial infarction, unstable cardiac or respiratory function, recent major surgery)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Greater than 85% of predicted maximal heart rate achieved during each exercise session in over 50% of patients as determined using a heart rate monitor worn around the chest at baseline, post exercise and 6 weeks for group one, and at baseline, end of group 1 exercise, post-exercise and 6 week follow-up for group two. | — |
Secondary
| Measure | Time frame |
|---|---|
| Group 1 will have 3 assessments (baseline, post-exercise and 6 week follow-up) and group 2 will have 4 assessments (baseline, end of group 1 exercise, post-exercise and 6 week follow-up). 1. Adverse events (e.g. cardiac events, feeling unwell, slips, trips and falls) are recorded during each exercise session 2. Attendance at sessions is determined using a register at each session 3. Brain derived neurotrophic factor levels (BDNF) are measured using a standard assay of blood samples taken Immediately before the first exercise session, immediately after (5 minutes maximum) first exercise session, immediately before last exercise session, immediately after (5 minutes maximum) last exercise session, at 6-week follow-up assessment. In addition, the delayed start group (group II) will have two extra samples taken at the time of the start and finish of the exercise intervention for group I 4. Cardiac stroke volume is measured using a four-lead Cheetah-NICOM monitor at all assessment point 5. Carer (close family member) quality of life is measured using the validated PDQ-carer assessment at all assessment points 6. Cognitive function is measured using the Montreal Cognitive Assessment (MoCA) at all assessment points. 7. Lung function is determined by measuring forced expiratory volume in 1 second (FEV1) using spirometry at all assessment points 8. Total forced vital capacity is measured using spirometry at all assessment point 9. Gait and balance are measured using the Tinetti scale at all assessment points 10. Physical function is measured using the Barthel Index at all assessment points 11. Quadriceps muscle strength is measured using a hand-held dynamometer at all assessment point 12. Attitudes towards exercise are assessed at baseline and post-intervention via focus group discussions led by a health psychologist 13. Quality of life is measured using the PDQ-39 questionnaire at all assessment points 14. Walking distance is measured using the six minute walk test at all | — |
Countries
United Kingdom
Outcome results
None listed