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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06444685
Other study ID # 2023CRINDESTABC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2023
Est. completion date June 30, 2026

Study information

Verified date May 2024
Source Universitat de Lleida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Quasi-experimental, controlled, non-randomised two-arm pilot, with an experimental group (table tennis exercise) and an active control group (cognitive training based on board games).


Description:

Quasi-experimental, controlled, non-randomised two-arm pilot, with an experimental group (table tennis exercise) and an active control group (cognitive training based on board games). Interventions in both groups will take place twice a week for 6 weeks (12 sessions in total). The main variables to be assessed will be motor and cognitive. As secondary variables, clinical and daily life aspects will be assessed. As results, it is expected that the experimental group will obtain improvements in motor variables compared to the control group after receiving the interventions. However, improvements in cognitive variables and secondary variables are expected to be similar in both groups.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date June 30, 2026
Est. primary completion date June 30, 2025
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria: - Diagnosis of Parkinson's Disease based on the UK PD Society Brain Bank Criteria - Stage I to III on the Hoehn and Yahr scale - Ability to walk for 10 minutes unassisted Exclusion Criteria: - Score of under 23 on the Mini-Mental State Examination - Severe Visual or Auditory deficits - Cardiovascular conditions that impede physical activity - Brain surgery

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise and cognitive training interventino
Exercise and cognitive training based on Table tennis and Tabletop games.

Locations

Country Name City State
Spain Institut de Recerca Biomèdica de Lleida Lleida

Sponsors (3)

Lead Sponsor Collaborator
Universitat de Lleida Asociació de Parkinson de les Terres de Lleida, Club Tennis Taula Borges Blanques

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Alexander GE, Crutcher MD, DeLong MR. Basal ganglia-thalamocortical circuits: parallel substrates for motor, oculomotor, "prefrontal" and "limbic" functions. Prog Brain Res. 1990;85:119-46. — View Citation

Estrada-Plana V, Montanera R, Ibarz-Estruga A, March-Llanes J, Vita-Barrull N, Guzman N, Ros-Morente A, Ayesa Arriola R, Moya-Higueras J. Cognitive training with modern board and card games in healthy older adults: two randomized controlled trials. Int J Geriatr Psychiatry. 2021 Jun;36(6):839-850. doi: 10.1002/gps.5484. Epub 2021 Jan 8. — View Citation

Inoue K, Fujioka S, Nagaki K, Suenaga M, Kimura K, Yonekura Y, Yamaguchi Y, Kitano K, Imamura R, Uehara Y, Kikuchi H, Matsunaga Y, Tsuboi Y. Table tennis for patients with Parkinson's disease: A single-center, prospective pilot study. Clin Park Relat Disord. 2020 Dec 30;4:100086. doi: 10.1016/j.prdoa.2020.100086. eCollection 2021. — View Citation

Olsson K, Franzen E, Johansson A. A Pilot Study of the Feasibility and Effects of Table Tennis Training in Parkinson Disease. Arch Rehabil Res Clin Transl. 2020 Jun 2;2(3):100064. doi: 10.1016/j.arrct.2020.100064. eCollection 2020 Sep. — View Citation

Shahed J, Jankovic J. Motor symptoms in Parkinson's disease. Handb Clin Neurol. 2007;83:329-42. doi: 10.1016/S0072-9752(07)83013-2. No abstract available. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Amplitude of Center of Pressure under simple conditions Assessment of amplitude of Center of Pressure (in mm) during balance testing using OPAL Sensors (APDM, Oregon, USA). Assessed before starting the intervention (T0) and 6 weeks later (T0 + 6 weeks).
Primary Amplitude of Center of Pressure under Dual Task conditions (Motor) Assessment of amplitude of Center of Pressure (in mm) during balance testing under concurrent cognitive tasks (Motor, by holding a glass of water on a tray) using OPAL Sensors (APDM, Oregon, USA). Assessed before starting the intervention (T0) and 6 weeks later (T0 + 6 weeks).
Primary Amplitude of Center of Pressure under Dual Task conditions (Arithmetic) Assessment of amplitude of Center of Pressure (in mm) during balance testing under concurrent cognitive tasks (Arithmetic, by concurrently substracting 7 from a random number) using OPAL Sensors (APDM, Oregon, USA). Assessed before starting the intervention (T0) and 6 weeks later (T0 + 6 weeks).
Primary Amplitude of Center of Pressure under Dual Task conditions (Verbal) Assessment of amplitude of Center of Pressure (in mm) during balance testing under concurrent cognitive tasks (Verbal, by naming words starting by a random letter) using OPAL Sensors (APDM, Oregon, USA). Assessed before starting the intervention (T0) and 6 weeks later (T0 + 6 weeks).
Primary Trail-Making Test Assessment of Trail-Making Test parts A and B Assessed before starting the intervention (T0) and 6 weeks later (T0 + 6 weeks).
Secondary United Parkinson's Disease Rating Scale - Part III Assessment of Motor symptoms of Parkinson's Disease with a predetermined assessment Assessed before starting the intervention (T0) and 6 weeks later (T0 + 6 weeks).
Secondary Montreal Cognitive Assessment Assessment of cognitive status to detect Mild Cognitive Impairment with a preset questionnaire. Assessed before starting the intervention (T0) and 6 weeks later (T0 + 6 weeks).
Secondary Parkinson's Disease Questionnaire - 8 Assessment of Quality of Life for people with Parkinson's Disease through a self-administered questionnaire Assessed before starting the intervention (T0) and 6 weeks later (T0 + 6 weeks).
Secondary Timed Up and Go test Assessment of gait mobility and fall risk by getting up from a chair, walking 3 meters, turning back and sitting again. Assessed before starting the intervention (T0) and 6 weeks later (T0 + 6 weeks).
Secondary Falls Efficacy Scale International Assessment of perceived fall risk with a predetermined questionnaire. Assessed before starting the intervention (T0) and 6 weeks later (T0 + 6 weeks).
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