Motor and Cognitive Exercise in Parkinson's Disease.

Официальное название

Motor and Cognitive Exercise in Parkinson's Disease. A Feasibility Randomized Clinical Trial

Обзор

The aim of this study is to examine the effects of a specialized multi-modal intervention in patients with moderate to advanced Parkinson's disease (PD). The hypothesis is that a specialized motor- and cognitive exercise program in addition to usual care can improve gait and balance better than usual care alone. 48 patients with PD and a symptom duration of 4 or more years will be randomized 1:1 to either a control arm or to an intervention arm. The control arm will have usual management of their PD. The intervention arm will receive exercises aimed at both motor and cognitive impairments of PD over the course of 12 weeks. The study has been designed in partnership with the Copenhagen Trial Unit (CTU), Copenhagen Univeristy Hospital, to ensure both internal and external validity. To increase reproducibility, detailed protocols for all training modalities will be shared along with the study results. This study is a feasibility study with the intention of a following international multi-center study to corroborate the results. Both feasibility outcomes for the intervention itself and clinical outcomes for the participants will be published.

Подробное описание

Intervention: The exercise program will consist of gait and balance training, lower body strength training and dual task training while treadmill walking. The program will include an individualized and progressive exercise program 3 times x 1 hour a week for 12 weeks with the following exercise modalities:

1. Treadmill training for gait and balance training combined with dual task motor cognitive training. 2. Progressive gait and motor-cognitive balance exercises 3. Progressive resistance training including leg press.

The program will be conducted under supervision by a physiotherapist or an exercise physiologist. Usual treatment is permitted during the trial, both pharmacological and non-pharmacological. The treatment is preferably stable during the intervention and follow-up, but necessary changes will be registered.

All participants will be examined at baseline, after 12 weeks and again 6 and 12 months after baseline.

Вмешательства

• Другое Motor-cognitive exercise
  3 weekly 1-hour sessions of motor-cognitive exercise. Each 1-hour session will be multi-modal with 20 minutes of dynamic balance training, 20 minutes of dual-task exercises while treadmill walking and 20 minutes of lower body strength training with leg press. Detailed protocols for the exercises will be published along with results.
• Другое Usual Care
  Best medical treatment: usual management of participants' PD and other potential comorbidities at the discretion of their regular physician and other health providers.

Первичные конечные точки

• Feasibility: Intervention adherence [Срок оценки: From allocation to the end of 12 weeks of intervention (T2)]
• Exploratory composite clinical outcome: Significant fall, all-cause hospitalization and all-cause mortality [Срок оценки: From enrollment to 1-year follow-up (T4)]

Вторичные конечные точки (5)

• Feasibility: Missing data (primary clinical outcome) [Срок оценки: From enrollment to 6-month follow-up (T3)]
• Feasibility: Missing data (secondary clinical outcomes) [Срок оценки: At baseline (T1), end of intervention at 12 weeks (T2), follow-up at 6 months (T3) and follow-up at 1 year (T4).]
• Feasibility: Randomization rate [Срок оценки: From screening to baseline, up to 1 year.]
• Feasibility: Drop-out rate [Срок оценки: Through study completion, an average of 1 year]
• Feasibility: Treatment fidelity [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

• Diagnosis of PD according to MDS-PD criteria
• Aged ≥ 18 years
• Informed consent
• PD symptoms ≥ 4 years
• Independent gait

Критерии исключения

• Diagnosis of PD Dementia according to the MDS-PD Dementia criteria

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Дания · 1 центр

• Department of Neurology, Bispebjerg and Frederiksberg Hospital — Copenhagen NV

Идентификаторы

NCT: NCT07465107 · H-25001087 · p-2025-18530

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗