NCT05066880

Brief Summary

In recent years, there is growing interest in illustrating the health benefits of exercise among epilepsy. Although exercise is recommended for patients with epilepsy, there is uncertainty concerning the effects of yoga and aerobic exercise on multiple health outcomes in epilepsy. The aim of this trial is to examine the effects of yoga and aerobic exercise training on physical activity, health-related physical fitness, mental, emotional, and psychological health status, seizure frequency and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 23, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

October 7, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

May 16, 2024

Status Verified

December 1, 2022

Enrollment Period

2.2 years

First QC Date

September 23, 2021

Last Update Submit

May 15, 2024

Conditions

EpilepsyEpilepsy; SeizureEpilepsy Idiopathic

Keywords

epilepsyyogaaerobicexercise

Outcome Measures

Primary Outcomes (2)

  • Physical activity in daily life

    Physical activity will be objectively monitored with an accelerometer.

    change from baseline to 8 weeks

  • Seizure

    Participants will be given a seizure diary and requested to record the number of their seizure.

    change from baseline to 8 weeks

Secondary Outcomes (16)

  • Six-Minute Walk test

    change from baseline to 8 weeks

  • 30-second Chair Stand test

    change from baseline to 8 weeks

  • Biodex Balance System

    change from baseline to 8 weeks

  • Bioelectrical impedance analyzer

    change from baseline to 8 weeks

  • Waist and hip circumference

    change from baseline to 8 weeks

  • +11 more secondary outcomes

Study Arms (3)

Yoga

EXPERIMENTAL

Participants allocated to the yoga group will receive the yoga-based intervention through an internet-based video conference remotely in real-time. Each class will accommodate a maximum of 5 subjects. A qualified physiotherapist who was a certificated yoga instructor will teach in these classrooms. The 8-week exercise intervention consists of three times per week sessions of yoga.

Other: Exercise training

Aerobic exercise

EXPERIMENTAL

Participants of the aerobic exercise group will be requested to perform unsupervised aerobic training in the home environment (e.g., at home, park, backyard, or in the local gym). The 8-week exercise intervention consists of three times per week sessions of aerobic exercise. Training will consist of a 10-min warm-up period, aerobic activity, and 5-min cool-down period.

Other: Exercise training

Wait-list

NO INTERVENTION

Participants in the wait-list group will be advised to continue their habitual physical activity next to usual medical care. A yoga or aerobic exercise program of 8 weeks will be offered after the ending of the study period.

Interventions

Exercise trainingOTHER

Exercise training for 8 weeks

Aerobic exerciseYoga

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with epilepsy diagnosed by a neurologist using the International League Against Epilepsy (ILAE) criteria,
  • Having access to the internet at least three per week.

You may not qualify if:

  • Any history of neurological disorders other than epilepsy,
  • Significant physical and cognitive impairments,
  • Musculoskeletal comorbid conditions,
  • Contraindications for an exercise intervention including diagnosed cardiovascular, pulmonary, or endocrine diseases,
  • Pregnancy,
  • Mental deficiency or low education level to understand the questionnaires,
  • Currently participating in an exercise program,
  • Volunteers who miss 3 consecutive intervention sessions, and do not participate in 10% of sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University

Izmir, Turkey (Türkiye)

Location

Related Publications (1)

  • Aktar B, Balci B, Eraslan Boz H, Oztura I, Baklan B. Yoga and aerobic exercise in epilepsy: Study protocol for a randomized controlled trial. Physiother Res Int. 2023 Oct;28(4):e2013. doi: 10.1002/pri.2013. Epub 2023 May 7.

    PMID: 37151132DERIVED

MeSH Terms

Conditions

EpilepsyMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Institute of Health Sciences

Study Record Dates

First Submitted

September 23, 2021

First Posted

October 4, 2021

Study Start

October 7, 2021

Primary Completion

January 1, 2024

Study Completion

May 1, 2024

Last Updated

May 16, 2024

Record last verified: 2022-12

Locations

TU(1)