Improve walking stability with exercise
- Trial ID
- NCT07618728
- Official Title
- Feasibility and Preliminary Effectiveness of an Individualized Multimodal Group-Based Exercise Programme for People With Parkinson's Disease: A Non-Randomized Feasibility Study
- Goal
- Improve walking stability with exercise
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Universidad Rey Juan Carlos
- Study Type
- INTERVENTIONAL
- Enrollment
- 64 participants
- Conditions
- PARKINSON DISEASE (Disorder)
- Interventions
- Exercise Group
Summary For Families
A team is testing whether a tailored, multimodal group exercise program can be safely delivered and help improve balance, strength, walking and daily function in people with early to mid-stage Parkinson's. Participants do small, supervised group classes with individualized strength, aerobic, balance and flexibility exercises, designed to boost muscle power, endurance and motor control and to complement medications like levodopa rather than replace them. Adults 18 and older with idiopathic Parkinson's at Hoehn and Yahr stages 1 to 3 who can follow instructions are eligible, while people with other neurological or serious medical conditions, significant cognitive impairment (MoCA < 21), recent hospitalization or recent structured exercise are excluded. About 64 people will enroll, with control participants matched to the exercise group by age, sex and disease stage in a sequential recruitment plan to check feasibility and early benefits.
Locations
- Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Exercise Group. A team is testing whether a tailored, multimodal group exercise program can be safely delivered and help improve balance, strength, walking and daily function in people with early to mid-stage Parkinson's. Participants do small, supervised group classes with individualized strength, aerobic, balance and flexibility exercises, designed to boost muscle power, endurance and motor control and to complement medications like levodopa rather than replace them. Adults 18 and older with idiopathic Parkinson's at Hoehn and Yahr stages 1 to 3 who can follow instructions are eligible, while people with other neurological or serious medical conditions, significant cognitive impairment (MoCA < 21), recent hospitalization or recent structured exercise are excluded. About 64 people will enroll, with control participants matched to the exercise group by age, sex and disease stage in a sequential recruitment plan to check feasibility and early benefits.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 9 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.