NCT07907302 Strength and Dual-Task on Sarcopenia in People With Parkinson's Disease
| NCT ID | NCT07907302 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Valencia |
| Condition | PARKINSON DISEASE (Disorder) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2027-01-11 |
| Primary Completion | 2027-01-29 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2027-01-11 with a primary completion date of 2027-01-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Parkinson´s disease and parkinsonian syndromes are associated with progressive motor and non-motor impairments that may compromise functional independence and quality of life. Sarcopenia, characterized by reduced muscle strength, muscle mass, and physical performance, is highly prevalent in these populations and may contribute to an increased risk of falls, frailty, and disability. This prospective, parallel-group, three-arm randomized controlled trial aims to compare the effects of three levels of physiotherapy intervention on sarcopenia-related parameters and physical function in adults with Parkinson´s disease or parkinsonian syndromes. The Education Group will receive standarized nutritional education and general physical exercise recommendations through structed educational materials, without supervised exercise training. The Progressive Resistance Training (PRT) Group will receive standarized nutritional education and participate in supervised progressive resistance trained combined with cognitive dual-task exercises. The PRT plus Instability Group will receive the same nutritional education, progressive resistance training, and cognitive dual-task training, with additional instability and postural control components. Participants in the two supervised exercise groups will complete two physiotherapy sessions per week for 12 weeks. Assessments will be conducted at baseline (T0), immediately after the 12-week intervention (T1), and four weeks after completion of the intervention (T2). Outcomes will include clinical and functional status, muscle strength, body composition and other sarcopenia-related measures, physical performance, nutritional status, neurocognitive status, number of falls, and Parkinson's disease-related clinical characteristics. The study will evaluate the effects of supervised progressive resistance training compared with an educational intervention and will explore whether adding instability and postural control demands to progressive resistance training provides additional effects on physical function, sarcopenia-related outcomes, and fall-related functional risk in people with Parkinson's disease and parkinsonian syndromes.
Eligibility Criteria
Inclusion Criteria: * Clinical diagnosis of Parkinson's disease or parkinsonism confirmed by a neurologist. * Hoehn and Yahr stage 1-3. * Age ≥18 years. * Stable antiparkinsonian drug treatment for at least the previous 4 weeks. * Ability to ambulate independently, with or without assistive devices. * Ability to understand and follow basic safety instructions. Exclusion Criteria: * Severe or uncontrolled additional pathology. * Other neurological diseases that interfere with the assessment. * Recent fractures. * Severe dyskinesias or unpredictable motor fluctuations that compromise safety. * Any medical condition that contraindicates supervised physical exercise
Contact & Investigator
Anna Arnal Gómez, PhD
PRINCIPAL INVESTIGATOR
Department of Physiotherapy, University of Valencia
Frequently Asked Questions
Who can join the NCT07907302 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying PARKINSON DISEASE (Disorder). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07907302 currently recruiting?
Yes, NCT07907302 is actively recruiting participants. Contact the research team at anna.arnal@uv.es for enrollment information.
Where is the NCT07907302 trial being conducted?
This trial is being conducted at Valencia, Spain.
Who is sponsoring the NCT07907302 clinical trial?
NCT07907302 is sponsored by University of Valencia. The principal investigator is Anna Arnal Gómez, PhD at Department of Physiotherapy, University of Valencia. The trial plans to enroll 60 participants.
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