NCT06444685

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
1mo left

Started Oct 2023

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Oct 2023Jun 2026

Study Start

First participant enrolled

October 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 5, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

June 5, 2024

Status Verified

May 1, 2024

Enrollment Period

1.7 years

First QC Date

March 12, 2024

Last Update Submit

May 30, 2024

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (5)

  • 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).

  • 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).

  • 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).

  • 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).

  • 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 Outcomes (5)

  • United Parkinson's Disease Rating Scale - Part III

    Assessed before starting the intervention (T0) and 6 weeks later (T0 + 6 weeks).

  • Montreal Cognitive Assessment

    Assessed before starting the intervention (T0) and 6 weeks later (T0 + 6 weeks).

  • Parkinson's Disease Questionnaire - 8

    Assessed before starting the intervention (T0) and 6 weeks later (T0 + 6 weeks).

  • Timed Up and Go test

    Assessed before starting the intervention (T0) and 6 weeks later (T0 + 6 weeks).

  • Falls Efficacy Scale International

    Assessed before starting the intervention (T0) and 6 weeks later (T0 + 6 weeks).

Study Arms (2)

Table Tennis

EXPERIMENTAL

Participants will follow supervised Table Tennis sessions lasting 60 minutes during 6 weeks, for a total of 12 sessions.

Other: Exercise and cognitive training interventino

Tabletop Games

EXPERIMENTAL

Participants will follow supervised Tabletop Game sessions lasting 60 minutes during 6 weeks, for a total of 12 sessions.

Other: Exercise and cognitive training interventino

Interventions

Exercise and cognitive training interventinoOTHER

Exercise and cognitive training based on Table tennis and Tabletop games.

Table TennisTabletop Games

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Score of under 23 on the Mini-Mental State Examination
  • Severe Visual or Auditory deficits
  • Cardiovascular conditions that impede physical activity
  • Brain surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Recerca Biomèdica de Lleida

Lleida, 25006, Spain

RECRUITING

Related 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.

    PMID: 2094891BACKGROUND

  • 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.

    PMID: 18808920BACKGROUND

  • 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.

    PMID: 34316664BACKGROUND

  • 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.

    PMID: 33543090BACKGROUND

  • 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.

    PMID: 33275804BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 12, 2024

First Posted

June 5, 2024

Study Start

October 1, 2023

Primary Completion

June 30, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

June 5, 2024

Record last verified: 2024-05

Locations

ES(1)