The purpose of this study is to learn how exercise affects sleep and memory in adults who have Parkinson’s disease.
We want to learn how two different workout programs affect sleep and memory in adults with Parkinson’s disease. One program is called progressive resistance training. In this program, you do five exercises for three sets of 8 to 12 repetitions, along with trunk exercises, and three to four bodyweight exercises. The second program is called the delayed exercise group. In this program, you do not change your physical activity or diet for the first 12 weeks. After that, you take part in 12 weeks of progressive resistance training.
If you decide to join the study, your first visit will be to see if you are a good fit for the study. You will answer questions about yourself and your life, have a physical exam, and get an electrocardiogram. The researchers will also check if it is safe for you to take part in an exercise program. You will be asked to complete an overnight sleep test at home so we can check your oxygen levels while you sleep. If you are a woman, you may be asked to give a urine sample for a pregnancy test. If you qualify for the study, you will complete a baseline visit. During this visit, you will be asked about your health information and the medications you take. You will fill out questionnaires about your mood, lifestyle, memory, and sleep. You will keep a diary to track your sleep habits and wear a watch that measures your activity. At this visit, you will also be randomly placed in either the progressive resistance training group or the delayed exercise group, kind of like a flipping a coin. You will also have extra tests, such as an MRI to look at your brain activity and a DEXA scan to measure your muscle, fat, and bone strength. There is also an optional blood draw that can be used for future research. You do not have to pay to be in the study.
There are many in-person study visits. Depending on which exercise program you are randomly placed in, the exercise part will last 12 to 24 weeks. During this time, you will need to come in three times a week. There are also some virtual visits. You will be in the study for about 33 weeks in total.
You may be able to join this study if you are 45 years of age or older, have Parkinson's disease, have no limits on exercise, and are not currently following an exercise routine. You must not have any uncontrolled health problems, such as untreated sleep apnea or narcolepsy.
You also need a study partner who spends at least 10 hours a week with you. If you are a healthy adult healthy without Parkinson's disease and are 45 years or older, you may also qualify to join the study as a healthy volunteer.
Protocol Number: 22-1685
More information available at ClinicalTrials.gov: NCT04796506
Principal Investigator