Parkinson's disease Nervous System Diseases
Conditions
Interventions
Participants will be randomised (stratified according to Hoehn & Yahr stage 1-3) to either a) an 8-week community based participant-led sub-maximal aerobic exercise programme e.g. community walking, c
or b) usual care / physical activity (control).
Participants will record on a daily diary sheet the time they have spent exercising and the type of exercise they have done. This diary
Sponsors
Keele University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults (male and female) aged over 18 years old, diagnosed with Parkinson’s according to the UK Brain Bank Criteria. 2. Disease severity classified between I-III according to the Hoehn and Yahr scale. Patients with I-III scores on Hoehn and Yahr are able to walk independently without assistance. Participants will be requested to do a sub-maximal CPET, therefore they need to be walking independently. 3. Ability to stand and walk for at least 10 meters without assistance. 4. Ability to understand instructions, with Mini-Mental State Examination score (MMSE) =24 (scores <24 reflect cognitive impairment).
Exclusion criteria
Exclusion criteria: 1. Pre-existing diagnosis of lung disease, e.g. chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis, emphysema, lung cancer. 2. Current smoker. 3. Participants with a history of heart disease that would present a risk of adverse cardiac event in response to the sub-maximal exercise tests (in accordance with the American Heart Association/ American College of Sport Medicine guidelines) as identified using the American Heart Association/ American College of Sport Medicine (AHA/ACSM) Health/Fitness Facility Pre-Participation Questionnaire. 4. Any other previously diagnosed musculoskeletal or neurological disorder that may prevent participation in physical activity. 5. Inability to understand English language (for the purpose of understanding instructions and information related to the study, as no interpreter is available). 6. Participants are required to sign a consent form, understand the instructions of the tests, the interventions and answer questionnaires. Thus, participants will be excluded from the study if they have dementia (as indicated by a MMSE score <24), or any other neurological or psychiatric disorder that would mean participants were unable to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment, refusal and attrition rates. 2. Measures of pulmonary function: Lung volumes using spirometry - recorded at baseline (week 0), post-intervention (week 8) and at follow-up (week 12) 2.1 Forced expiratory volume in one second (FEV1) (the maximum amount of air that a person can forcibly breath out in one second). 2.2 Forced vital capacity (FVC) (the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible). 2.3 Ratio of FEV1/FVC to identify any airflow limitation compared to established normative values. 3. Cardiovascular response to sub-maximal exercise, measured by cycle cardiopulmonary exercise test (CPET) recorded at baseline (week 0), post-intervention (week 8) and at follow-up (week 12): 3.1 Predicted peak oxygen uptake (VO2peak %pred) to identify the predicted maximum amount of oxygen a person can utilise during exercise, a measure of cardiorespiratory fitness. 3.2 Heart rate (HR) during the CPET. 3.3 Blood pressure (systolic (SBP) and diastolic (DBP)). 3.4 Maximum workload (power of the cycle) achieved. 3.5 Test duration (how many minutes of exercise could the participant manage before stopping). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective measure of daily physical activity levels, by using a physical activity monitor (ActiGraph; Pensacola, FL) - recorded post-intervention (week 8) 1.1 Level of physical activity while walking measured by counts (count is the unit of movement in accelerometer in the three axes X, Y and Z) per minute. 1.2 Metabolic equivalents (METs) spent while walking (metabolic equivalent is a physiological measure expressing the energy cost of physical activities and is defined as the ratio of metabolic rate (and therefore the rate of energy consumption) during a specific physical activity), as a measure of intensity of exercise. METs=calories/(weight x time). 1.3 Steps/minute. 1.4 METs spent in different daily activities during the study period. 1.5 The activity monitors will be programmed only to detect physical activity measures, and will not record any GPS or location date. 1.6 In addition to the actigraph, an exercise diary will be provided for participants to record the duration and type of the additional aerobic exercise they have undertaken each day 2. Quality of life: Parkinson’s quality of life questionnaire (PDQ-39) - recorded at weeks 0 and 8. 3. Depression: The Geriatric Depression Screening Questionnaire - recorded at weeks 0 and 8. 4. Independence in activities of daily living: Barthel Index - recorded at weeks 0 and 8. 5. Non-motor symptoms: Parkinson’s non-motor symptoms questionnaire - recorded at weeks 0 and 8. 6. Memory: Prospective-Retrospective Memory Questionnaire - recorded at weeks 0 and 8 | — |
Countries
England, United Kingdom
Outcome results
None listed