Parkinson DiseaseSTEPNCT02622737
Study of the Effects of Three Exercise Programs in Parkinson's Disease
A study testing Functional training, Stationary bike and Exergaming in people with Parkinson Disease, run by Federal University of Bahia at 1 site in Brazil.
Trial summary
Introduction: Population aging is associated with increased prevalence of chronic diseases. Parkinson's disease (PD) is the second most common neurodegenerative disease in the world population, affecting motor function and functional independence progressively. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Functional training, Stationary bike and Exergaming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Dec 2015to Mar 2018
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Regular use of medication for PD;
- Age greater than or equal to 60 years;
- Stage 2, 2.5 or 3 according to the modified Hoehn and Yahr classification;
- Signed informed consent.
Who cannot join
- neurodegenerative diseases other than Parkinson disease; dementia; muscle diseases that preclude the practice of physical activity; chronic uncontrolled disease (hypertension, diabetes mellitus, chronic pain); unstable cardiovascular disease (acute heart failure, myocardial recent infarction, unstable angina and uncontrolled arrhythmia); using alcohol and other toxic substances; contraindications for performing exercise according the criteria of the American College of Sports Medicine; to practice or have practiced physical exercise program in the last six months; to participate or have participated in regular resistance training (eg, 2-3 times per week) in the previous 12 months.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro de Referencia Estadual de Atencao a Saude do Idoso (CREASI)
Salvador, Estado de Bahia, 41820000
About this study
Official title: Comparison of the Effects of Exercise by Functional Training, Stationary Bicycle and Exergame in Parkinson Disease
Introduction: Population aging is associated with increased prevalence of chronic diseases. Parkinson's disease (PD) is the second most common neurodegenerative disease in the world population, affecting motor function and functional independence progressively. The physiological aging promotes the gradual reduction of body weight, lung function, peripheral muscle strength, cardiopulmonary endurance and physical capacity, which increase the debilitating effects. Aging, when associated with PD, can induce loss of functionality, postural changes, further affecting the nutritional status, worsening the quality of life and functional independence of the individual. Although physical therapy is commonly applied with a variety of methodologies to PD patients, evidence for the effectiveness of these interventions is lacking.
Objective: The primary objective of the study is to compare the effects of Functional Training, Stationary Bike and Exergaming Exercises on proportion of fallers in elderly participants with PD. In addition, the secondary objectives are to compare the effects on cardiopulmonary endurance, posture, postural control, executive function, quality of life and functionality of individuals with PD.
Methodology: This is an interventional, randomized, blinded, longitudinal and prospective study. This research will be conducted in the State Reference Center for Health Care of the Elderly (CREASI). The sample will consist of 63 individuals with PD per group. The Experimental Group 1 will be submitted to Functional Training, the Experimental Group 2 with undergo training with Stationary Bike and the Experimental Group 3 will be submitted to exergame training using Xbox360 with KinectTM sensor. All the interventions will be performed three times per week, with 50 minutes per session, during 8 weeks.
Read the detailed description
The original study goal was to recruit 210 subjects based on the assumption of a fall risk of 70% in the Bicycle group and 40% in either Exergaming or Functional Training groups, with 80% power and alpha=0.05.
GROUPS:
G1-Functional Training
The intensity was increased by progressive resistance with dumbbells, ankle weights, elastic bands and manual resistance.
- Gait with obstacles: To perform this exercise hula hoops, rubber cones, plastic sticks, wood steps and mattresses were used.
- Up and down stairs and ramp: The participant went up and down 3 steps and 1 ramp until completing 3 minutes.
- Sitting and standing exercises: To increase the difficulty level were used manual resistance, dumbbell and unstable bases (swiss ball).
- Side gear and shin guards: The participant performed side gait according to the physical therapist's commands.
- Balance exercise: The participant performed balance exercises in proprioceptive platforms: balance discs, jumping beds proprioceptive tables.
- Activities with ball: Kicking balls of different sizes and weights, alternating each foot.
- Step exercises: Going up and down steps with the right or left foot according to cognitive commands of the physical therapist.
- Foot tip exercises: The participant performed the exercise on flat and sloped surface with one or two feet maintaining sural triceps contraction for 5 seconds.
- Graded reaching exercises: The exercise was performed standing and sitting. Dual task activities were performed.
- Gait training: The participant walked around the gym following verbal commands to stop and change direction. Gait reeducation consisted of working scapular and pelvic girdle dissociation.
G2-Bicycle
Aerobic training on a stationary bicycle: The training intensity was 50% of maximum heart rate (adjusted for age - Karvonen formula) in the first week, increasing gradually to 75% in the eighth week.
First week: 50% of maximum heart rate. Second and Third weeks: 55% of maximum heart rate. Fourth and Fifth weeks: 65% of maximum heart rate. Sixth and Seventh weeks: 70% of maximum heart rate. Eighth week: 75% of maximum heart rate. The intensity was increased progressively by bike endurance (resistance) and speed.
G3-Exergaming
Physical components involved in Exergames (Virtual Reality Exposure Therapy): strength and muscular endurance, cardiorespiratory fitness, postural balance, executive function and emotional demands.
The participants did not use weights to perform the exercises in the Exergame Group. A physical therapist guided the participants to explore the correct posture and the articular range of motion using both tactile and assistive stimulus and/or verbal command during the games. Each mini-game lasts about 3-minutes, and to complete 30-minutes training, the same one or two mini-games were repeated in different levels of intensity and speed in each session. Mini-games of Kinect Advenctures! game:
- River Rush: One or two players must control the raft using their body, moving from side to side, and jumping in front of the Kinect sensor. Players must work as a team to earn as many points as possible.
- Reflex Ridge: One or two players can move freely on platforms (rollercoaster-like tracks), allowing them to dodge left and right, duck and jump over hazards as they spring forward. Jumping in place makes the platform move faster along its rail.
- 20,000 Leaks: The characters are positioned in a rectangular glass tank underwater, and each of the tank's four walls can crack and begin to leak water at any time. One or two players stand in front of the Kinect sensor and use their arms and legs - or any other body parts - to stop leaking water.
- Conditions
- Parkinson Disease
- Being tested
- Functional training, Stationary bike, Exergaming
- Keywords
- Parkinson disease, Accidental Falls, Exercise therapy, Virtual Reality Exposure Therapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional trainingOther
Three times per week, with 50 minutes per session, during 8 weeks of training activities involving 10 minutes of muscle stretching, 5 minutes of warm-up exercise, 30 minutes of a functional training and 5 minutes of respiratory exercises.
Stationary bikeDevice
Three times per week, with 50 minutes per session, during 8 weeks of training activities involving 10 minutes of muscle stretching, 5 minutes of warm-up exercise, 30 minutes of a Stationary Bike exercise and 5 minutes of respiratory exercises.
ExergamingDevice
Also called Virtual Reality Exposure Therapy
Three times per week, with 50 minutes per session, during 8 weeks of training activities involving 10 minutes of muscle stretching, 5 minutes of warm-up exercise, 30 minutes of a Virtual Reality exercise (performed by Xbox360 with KinectTM sensor) and 5 minutes of respiratory exercises.
| Study group | Role | What they receive |
|---|---|---|
| Functional Training | Experimental | Functional exercise training program Receives: Other: Functional training |
| Stationary Bike | Experimental | Stationary bike training program Receives: Device: Stationary bike |
| Exergaming | Experimental | Virtual Reality Exposure Therapy Receives: Device: Exergaming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of recurrent fallers (2 or more falls over the study period)
Measured: 6 months after completion of the exercise training
Secondary outcomes (10)
Proportion of recurrent fallers (2 or more falls over the study period)
Measured: 3 months
Number of falls
Measured: 6 months
6-Minute Walk Test (cardiovascular endurance)
Measured: 8 weeks
Get Up and Down Test
Measured: 8 weeks
10 meters test (gait speed)
Measured: 8 weeks
Photometry-measured posture
Measured: 8 weeks
Balance Evaluation Systems Test - BESTEST
Measured: 8 weeks
Frontal Assessment Battery - FAB
Measured: 8 weeks
Quality of life on the Parkinson's Disease Questionnaire-39 - PDQ39
Measured: 8 weeks
World Health Organization Disability Assessment Schedule 2.0 - WHODAS 2.0
Measured: 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 Dec 2015 (estimated)
- Study start14 Dec 2015
- Primary completionMar 2018
- Study completionMar 2018
Why it stopped: The recruitment site changed their admission policy to only more severely affected patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Bahia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamary Oliveira-Filho, Federal University of Bahia
- Investigators
- Jamary Oliveira-Filho, MD, Principal investigator, Federal University of Bahia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622737
- Sponsor's protocol ID
- CAAE # 41228415.5.0000.5662
- Acronym
- STEP
- Status last verified
- Oct 2019
- First submitted
- 26 Nov 2015
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
PubMed 38588457Duarte GP, Ferraz DD, Trippo KV, Novais MCM, Sales M, Ribeiro NMDS, Oliveira Filho J. Effects of three physical exercise modalities on respiratory function of older adults with Parkinson's disease: A randomized clinical trial. J Bodyw Mov Ther. 2023 Oct;36:425-431. doi: 10.1016/j.jbmt.2023.05.014. Epub 2023 Aug 23.
PubMed 37949595Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
PubMed 36602886Ferraz DD, Trippo KV, Duarte GP, Neto MG, Bernardes Santos KO, Filho JO. The Effects of Functional Training, Bicycle Exercise, and Exergaming on Walking Capacity of Elderly Patients With Parkinson Disease: A Pilot Randomized Controlled Single-blinded Trial. Arch Phys Med Rehabil. 2018 May;99(5):826-833. doi: 10.1016/j.apmr.2017.12.014. Epub 2018 Jan 11.
PubMed 29337023
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Exercise by Functional Training, Stationary Bicycle and Exergame in Parkinson Disease
- ClinicalTrials.gov ID
- NCT02622737
- Acronym / sponsor ID
- STEP / CAAE # 41228415.5.0000.5662
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, Accidental Falls, Exercise therapy, Virtual Reality Exposure Therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The recruitment site changed their admission policy to only more severely affected patients.
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Federal University of BahiaUniversity, hospital or other
- Study start
- 14 Dec 2015 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 4 Dec 2015 (estimated)
- 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.
Introduction: Population aging is associated with increased prevalence of chronic diseases. Parkinson's disease (PD) is the second most common neurodegenerative disease in the world population, affecting motor function and functional independence progressively. The physiological aging promotes the gradual reduction of body weight, lung function, peripheral muscle strength, cardiopulmonary endurance and physical capacity, which increase the debilitating effects. Aging, when associated with PD, can induce loss of functionality, postural changes, further affecting the nutritional status, worsening the quality of life and functional independence of the individual. Although physical therapy is commonly applied with a variety of methodologies to PD patients, evidence for the effectiveness of these interventions is lacking.
Objective: The primary objective of the study is to compare the effects of Functional Training, Stationary Bike and Exergaming Exercises on proportion of fallers in elderly participants with PD. In addition, the secondary objectives are to compare the effects on cardiopulmonary endurance, posture, postural control, executive function, quality of life and functionality of individuals with PD.
Methodology: This is an interventional, randomized, blinded, longitudinal and prospective study. This research will be conducted in the State Reference Center for Health Care of the Elderly (CREASI). The sample will consist of 63 individuals with PD per group. The Experimental Group 1 will be submitted to Functional Training, the Experimental Group 2 with undergo training with Stationary Bike and the Experimental Group 3 will be submitted to exergame training using Xbox360 with KinectTM sensor. All the interventions will be performed three times per week, with 50 minutes per session, during 8 weeks.
Detailed description
The original study goal was to recruit 210 subjects based on the assumption of a fall risk of 70% in the Bicycle group and 40% in either Exergaming or Functional Training groups, with 80% power and alpha=0.05.
GROUPS:
G1-Functional Training
The intensity was increased by progressive resistance with dumbbells, ankle weights, elastic bands and manual resistance.
- Gait with obstacles: To perform this exercise hula hoops, rubber cones, plastic sticks, wood steps and mattresses were used.
- Up and down stairs and ramp: The participant went up and down 3 steps and 1 ramp until completing 3 minutes.
- Sitting and standing exercises: To increase the difficulty level were used manual resistance, dumbbell and unstable bases (swiss ball).
- Side gear and shin guards: The participant performed side gait according to the physical therapist's commands.
- Balance exercise: The participant performed balance exercises in proprioceptive platforms: balance discs, jumping beds proprioceptive tables.
- Activities with ball: Kicking balls of different sizes and weights, alternating each foot.
- Step exercises: Going up and down steps with the right or left foot according to cognitive commands of the physical therapist.
- Foot tip exercises: The participant performed the exercise on flat and sloped surface with one or two feet maintaining sural triceps contraction for 5 seconds.
- Graded reaching exercises: The exercise was performed standing and sitting. Dual task activities were performed.
- Gait training: The participant walked around the gym following verbal commands to stop and change direction. Gait reeducation consisted of working scapular and pelvic girdle dissociation.
G2-Bicycle
Aerobic training on a stationary bicycle: The training intensity was 50% of maximum heart rate (adjusted for age - Karvonen formula) in the first week, increasing gradually to 75% in the eighth week.
First week: 50% of maximum heart rate. Second and Third weeks: 55% of maximum heart rate. Fourth and Fifth weeks: 65% of maximum heart rate. Sixth and Seventh weeks: 70% of maximum heart rate. Eighth week: 75% of maximum heart rate. The intensity was increased progressively by bike endurance (resistance) and speed.
G3-Exergaming
Physical components involved in Exergames (Virtual Reality Exposure Therapy): strength and muscular endurance, cardiorespiratory fitness, postural balance, executive function and emotional demands.
The participants did not use weights to perform the exercises in the Exergame Group. A physical therapist guided the participants to explore the correct posture and the articular range of motion using both tactile and assistive stimulus and/or verbal command during the games. Each mini-game lasts about 3-minutes, and to complete 30-minutes training, the same one or two mini-games were repeated in different levels of intensity and speed in each session. Mini-games of Kinect Advenctures! game:
- River Rush: One or two players must control the raft using their body, moving from side to side, and jumping in front of the Kinect sensor. Players must work as a team to earn as many points as possible.
- Reflex Ridge: One or two players can move freely on platforms (rollercoaster-like tracks), allowing them to dodge left and right, duck and jump over hazards as they spring forward. Jumping in place makes the platform move faster along its rail.
- 20,000 Leaks: The characters are positioned in a rectangular glass tank underwater, and each of the tank's four walls can crack and begin to leak water at any time. One or two players stand in front of the Kinect sensor and use their arms and legs - or any other body parts - to stop leaking water.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Functional Training | Experimental | Other: Functional trainingFunctional exercise training program |
| Stationary Bike | Experimental | Device: Stationary bikeStationary bike training program |
| Exergaming | Experimental | Device: ExergamingVirtual Reality Exposure Therapy |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Regular use of medication for PD;
- Age greater than or equal to 60 years;
- Stage 2, 2.5 or 3 according to the modified Hoehn and Yahr classification;
- Signed informed consent.
Key exclusion criteria (1 listed)
- neurodegenerative diseases other than Parkinson disease; dementia; muscle diseases that preclude the practice of physical activity; chronic uncontrolled disease (hypertension, diabetes mellitus, chronic pain); unstable cardiovascular disease (acute heart failure, myocardial recent infarction, unstable angina and uncontrolled arrhythmia); using alcohol and other toxic substances; contraindications for performing exercise according the criteria of the American College of Sports Medicine; to practice or have practiced physical exercise program in the last six months; to participate or have participated in regular resistance training (eg, 2-3 times per week) in the previous 12 months.
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 |
|---|---|---|
| Functional trainingThree times per week, with 50 minutes per session, during 8 weeks of training activities involving 10 minutes of muscle stretching, 5 minutes of warm-up exercise, 30 minutes of a functional training and 5 minutes of respiratory exercises. | Other | Functional Training |
| Stationary bikeThree times per week, with 50 minutes per session, during 8 weeks of training activities involving 10 minutes of muscle stretching, 5 minutes of warm-up exercise, 30 minutes of a Stationary Bike exercise and 5 minutes of respiratory exercises. | Device | Stationary Bike |
| ExergamingAlso: Virtual Reality Exposure TherapyThree times per week, with 50 minutes per session, during 8 weeks of training activities involving 10 minutes of muscle stretching, 5 minutes of warm-up exercise, 30 minutes of a Virtual Reality exercise (performed by Xbox360 with KinectTM sensor) and 5 minutes of respiratory exercises. | Device | Exergaming |
Primary outcome
Proportion of recurrent fallers (2 or more falls over the study period)
Time frame: 6 months after completion of the exercise training
10 secondary outcomes
Proportion of recurrent fallers (2 or more falls over the study period)
Time frame: 3 months
Number of falls
Time frame: 6 months
6-Minute Walk Test (cardiovascular endurance)
Time frame: 8 weeks
Get Up and Down Test
Time frame: 8 weeks
10 meters test (gait speed)
Time frame: 8 weeks
Photometry-measured posture
Time frame: 8 weeks
Balance Evaluation Systems Test - BESTEST
Time frame: 8 weeks
Frontal Assessment Battery - FAB
Time frame: 8 weeks
Quality of life on the Parkinson's Disease Questionnaire-39 - PDQ39
Time frame: 8 weeks
World Health Organization Disability Assessment Schedule 2.0 - WHODAS 2.0
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: The recruitment site changed their admission policy to only more severely affected patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Derived from this study: PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
- Derived from this study: PubMed 37949595Duarte GP, Ferraz DD, Trippo KV, Novais MCM, Sales M, Ribeiro NMDS, Oliveira Filho J. Effects of three physical exercise modalities on respiratory function of older adults with Parkinson's disease: A randomized clinical trial. J Bodyw Mov Ther. 2023 Oct;36:425-431. doi: 10.1016/j.jbmt.2023.05.014. Epub 2023 Aug 23.
- Derived from this study: PubMed 36602886Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
- Derived from this study: PubMed 29337023Ferraz DD, Trippo KV, Duarte GP, Neto MG, Bernardes Santos KO, Filho JO. The Effects of Functional Training, Bicycle Exercise, and Exergaming on Walking Capacity of Elderly Patients With Parkinson Disease: A Pilot Randomized Controlled Single-blinded Trial. Arch Phys Med Rehabil. 2018 May;99(5):826-833. doi: 10.1016/j.apmr.2017.12.014. Epub 2018 Jan 11.
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
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.
Jamary Oliveira-Filho, MD principal investigator
Federal University of Bahia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional training, Stationary bike and Exergaming in people with Parkinson Disease, run by Federal University of Bahia at 1 site in Brazil.
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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 10 Oct 2019. 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 Brazil. 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 was stopped early (reason given: The recruitment site changed their admission policy to only more severely affected patients.). Results are not available in the source record.
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?
Proportion of recurrent fallers (2 or more falls over the study period) (time frame: 6 months after completion of the exercise training). 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 NCT02622737, which also lists 4 linked publications.
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 10 Oct 2019.