EpilepsyNCT05066880
Yoga and Aerobic Exercise in Epilepsy
A study testing Exercise training in people with Epilepsy and Epilepsy; Seizure, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy, Epilepsy; Seizure, Epilepsy Idiopathic
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Oct 2021to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Yoga and Aerobic Exercise Training on Physical and Mental Health in People With Epilepsy
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.
- Conditions
- Epilepsy, Epilepsy; Seizure, Epilepsy Idiopathic
- Being tested
- Exercise training
- Keywords
- epilepsy, yoga, aerobic, exercise
- Medical subject headings
- Epilepsy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
Exercise training for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity in daily life
Physical activity will be objectively monitored with an accelerometer.
Measured: change from baseline to 8 weeks
Seizure
Participants will be given a seizure diary and requested to record the number of their seizure.
Measured: change from baseline to 8 weeks
Secondary outcomes (16)
Six-Minute Walk test
The Six-Minute Walk test will be used to determine functional capacity.
Measured: change from baseline to 8 weeks
30-second Chair Stand test
Lower body strength will be determined using the 30-second Chair Stand test.
Measured: change from baseline to 8 weeks
Biodex Balance System
Balance evaluation will be performed with Biodex Balance System.
Measured: change from baseline to 8 weeks
Bioelectrical impedance analyzer
Body composition measurements will be performed with bioelectrical impedance analyzer.
Measured: change from baseline to 8 weeks
Waist and hip circumference
For the anthropometric measurements, waist and hip circumference will be taken.
Measured: change from baseline to 8 weeks
Trail Making test and Digit Span test
The Trail Making test and Digit Span test will be used to evaluate for attention.
Measured: change from baseline to 8 weeks
Stroop test and Verbal Fluency
The Stroop test and Verbal Fluency will be used to evaluate for executive functions.
Measured: change from baseline to 8 weeks
Weschler Memory Scale-Revised Visual Reproduction subtest
The Weschler Memory Scale-Revised Visual Reproduction subtest will be used to evaluate for visual memory.
Measured: change from baseline to 8 weeks
Clock Drawing test
The Clock Drawing test will be used to evaluate for visual perception and visual-spatial functions.
Measured: change from baseline to 8 weeks
Oktem Verbal Memory Processes test
The Oktem Verbal Memory Processes test will be used to evaluate for verbal memory performance.
Measured: change from baseline to 8 weeks
Neurological Disorders Depression Inventory for Epilepsy
The Neurological Disorders Depression Inventory for Epilepsy will be used to evaluate for depression.
Measured: change from baseline to 8 weeks
Generalized Anxiety Disorder-7
Anxiety will be determined by the Generalized Anxiety Disorder-7.
Measured: change from baseline to 8 weeks
10-item Perceived Stress Scale
The 10-item Perceived Stress Scale will be used to assess subjective stress.
Measured: change from baseline to 8 weeks
Fatigue Impact Scale
Fatigue will be assessed with the Fatigue Impact Scale.
Measured: change from baseline to 8 weeks
Pittsburg Sleep Quality Index
Sleep quality will be measured using the Pittsburg Sleep Quality Index.
Measured: change from baseline to 8 weeks
Quality of Life in Epilepsy Inventory-31
It will be used to determine health-related quality of life for epilepsy.
Measured: change from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start7 Oct 2021
- Primary completion1 Jan 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcin Aktar, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066880
- Sponsor's protocol ID
- 5258-GOA
- Status last verified
- Dec 2022
- First submitted
- 23 Sep 2021
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37151132
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Yoga and Aerobic Exercise Training on Physical and Mental Health in People With Epilepsy
- ClinicalTrials.gov ID
- NCT05066880
- Acronym / sponsor ID
- 5258-GOA
- Conditions
- Epilepsy, Epilepsy; Seizure, Epilepsy Idiopathic
- Keywords
- epilepsy, yoga, aerobic, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Other: Exercise trainingParticipants 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. |
| Aerobic exercise | Experimental | Other: Exercise trainingParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingExercise training for 8 weeks | Other | Aerobic exercise, Yoga |
Primary outcome
Physical activity in daily life
Time frame: change from baseline to 8 weeks
Physical activity will be objectively monitored with an accelerometer.
Seizure
Time frame: change from baseline to 8 weeks
Participants will be given a seizure diary and requested to record the number of their seizure.
16 secondary outcomes
Six-Minute Walk test
Time frame: change from baseline to 8 weeks
30-second Chair Stand test
Time frame: change from baseline to 8 weeks
Biodex Balance System
Time frame: change from baseline to 8 weeks
Bioelectrical impedance analyzer
Time frame: change from baseline to 8 weeks
Waist and hip circumference
Time frame: change from baseline to 8 weeks
Trail Making test and Digit Span test
Time frame: change from baseline to 8 weeks
Stroop test and Verbal Fluency
Time frame: change from baseline to 8 weeks
Weschler Memory Scale-Revised Visual Reproduction subtest
Time frame: change from baseline to 8 weeks
Clock Drawing test
Time frame: change from baseline to 8 weeks
Oktem Verbal Memory Processes test
Time frame: change from baseline to 8 weeks
Neurological Disorders Depression Inventory for Epilepsy
Time frame: change from baseline to 8 weeks
Generalized Anxiety Disorder-7
Time frame: change from baseline to 8 weeks
10-item Perceived Stress Scale
Time frame: change from baseline to 8 weeks
Fatigue Impact Scale
Time frame: change from baseline to 8 weeks
Pittsburg Sleep Quality Index
Time frame: change from baseline to 8 weeks
Quality of Life in Epilepsy Inventory-31
Time frame: change from baseline to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Derived from this study: PubMed 37151132Aktar 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Epilepsy and Epilepsy; Seizure, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity in daily life (time frame: change from baseline to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05066880, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.