An interventional study of Physical activity and usual clinical practice in Parkinson's Disease, sponsored by University Ramon Llull. Active, not recruiting at 1 site in Spain. Open to participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-02-25.
Sponsored by University Ramon Llull · Not applicable, Interventional, and Supportive care
The aim of this study is to investigate the effect of physical activity on mitochondrial function in skin fibroblasts in patients with Parkinson's disease.
A randomized double-blind clinical trial will be conducted to study the effects of physical activity on mitochondrial function in skin fibroblasts in patients with Parkinson's disease. It is an intervention study, and twenty-four patients will be needed. Once the subjects have been selected, they will be randomly assigned into three groups (eight patients in each group). The first group will perform basic physical training (BPT) based on strength and resistance, the second group will perform BPT combined with functional exercises (BPTFE) with cognitive and motor training, and the third group will not carry out any activity program, serving as control. The interventions will last 60 minutes, with a frequency of 3 times a week, during 16 weeks. The control group will receive 4 months of PA from the program that has obtained the best results,in terms of symptoms and quality of life, after the last evaluation.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 24 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University Ramon Llull is the lead sponsor of 19 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Exercises will target the large muscle groups, with a component/emphasis on the eccentric phase of concentration. The kBox4 Platform (Exxentric AB), a device designed to maximize performance and training outcomes, will be used to enhance the eccentric phase of the exercises. kBox4 is controlled by a specific program, Kmeter, which records and stores all the information (duration, intensity, repetitions, etc.) of each movement. Exxentric kBox4 will be adapted with special harnesses, insurances on the wall and in front of support bars, according to the needs of the patients. In addition to the major muscle groups, specific attention will be given to the key muscles involved in the gait cycle, such as the tibialis anterior, medial gastrocnemius, rectus femoris, and hamstrings, from a biomechanical perspective.
Other: Physical activity
In addition to the BPT program (which includes the transverse focus on strength and resistance exercises), this intervention group will incorporate functional exercises that involve dual task training. The dual task training can encompass both motor-motor and motor-cognitive activities. This means that coordinated exercises will be performed, with cognitive activities introduced at the extremes of the movement. This approach ensures engagement of both physical and cognitive abilities during the PA sessions.
Other: Physical activity
Participants in the control group will maintain their regular daily routines throughout the study period.
Other: usual clinical practice
This physical activity program will be based only on the work of basic physical training, in which specifically and mainly the strength and resistance will be worked, but also flexibility
Also known as: Exercise
usual clinical practice
Change in oxygen consumption rate
Oxygen uptake (VO2, mlkg-1min-1) measured by Seahorse XFe96
Time frame: Beginning of the study and after 4 months
Change in ATPmax levels
Maximal mitochondrial ATP production rates measured by Seahorse XFe96
Time frame: Beginning of the study and after 4 months
Non-motor and motor function
non-motor and motor experiences of daily living and motor complications measured by the MDS-Sponsored Revision of the UPDRS (MDS-UPDRS) questionnaire
Time frame: Beginning of the study, first visit
Sleepiness
Self-administered questionnaire with 8 questions measured by the Epworth Sleepiness Scale (ESS) questionnaire
Time frame: Beginning of the study, first visit
Mobility
clinical performance-based measure of lower extremity function, mobility and fall risk, measured by the Timed Up and Go Test (TUG) questionnaire
Time frame: Beginning of the study, first visit
Cognitive aspects
Cognitive aspects measured by the Montreal Cognitive Assessment scale (MoCA)
Time frame: Beginning of the study, first visit
Mood
Intensity of depression in clinical and normal patients measured by the Beck Depression Inventory (BDI) questionnaire
Time frame: Beginning of the study, first visit
Non-motor and motor function
non-motor and motor experiences of daily living and motor complications measured by the MDS-Sponsored Revision of the UPDRS (MDS-UPDRS) questionnaire
Time frame: End of the study (4 Months)
Sleepiness
Self-administered questionnaire with 8 questions measured by the Epworth Sleepiness Scale (ESS) questionnaire
Time frame: End of the study (4 Months)
Mobility
clinical performance-based measure of lower extremity function, mobility and fall risk, measured by the Timed Up and Go Test (TUG) questionnaire
Time frame: End of the study (4 Months)
Cognitive aspects
Cognitive aspects measured by the Montreal Cognitive Assessment scale (MoCA)
Time frame: End of the study (4 Months)
Mood
Intensity of depression in clinical and normal patients measured by the Beck Depression Inventory (BDI) questionnaire
Time frame: End of the study (4 Months)
Plan to share: No
This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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University Ramon Llull