Parkinson's DiseaseHYPDNCT02509611
Effects of Yoga on Parkinson's Disease
A study testing Hatha yoga in people with Parkinson's Disease, run by University of Minnesota at 1 site in United States.
Trial summary
The study's purpose is to assess the effect of yoga on measures of oxidative stress (i.e. reduction-oxidation [redox] status); motor function; and psychosocial well-being, and the feasibility and acceptability of implementing a Hatha yoga program in PD subjects. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Hatha yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Jun 2017
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals diagnosed with idiopathic PD;
- On optimized dopaminergic therapy for 4 weeks prior to enrollment; and
- Have not practiced any form of yoga regularly (more than 2 days a week) in the past 6 months; and
- Not currently participating in a supervised exercise program more than 2 days a week
Who cannot join
- Atypical Parkinsonism or other significant brain conditions such as a stroke;
- Fell more than once in the past 3 months;
- Moderate to severe cognitive impairment (scored <26) as indicated by the Montreal Cognitive Assessment;
- Decline in immune function such as pneumonia or systemic infection;
- Spinal fusion or other orthopedic surgery in the past 6 months;
- Unstable cardiovascular conditions;
- Significant mental disease or psychosis;
- Not able to ambulate 6 meters steadily without assistive device.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Effects of Yoga on Redox Status, Motor Function and Psychosocial Well-being in Individuals With Parkinson's Disease
The study's purpose is to assess the effect of yoga on measures of oxidative stress (i.e. reduction-oxidation [redox] status); motor function; and psychosocial well-being, and the feasibility and acceptability of implementing a Hatha yoga program in PD subjects.
Read the detailed description
The specific aims of this study are:
Aim 1: Determine the effect of a 12-week Hatha yoga program on redox status in individuals with PD.
Hypothesis 1a: Participants in the intervention group will have greater increases in total GSH levels and GSH: GSSG ratios from baseline than participants in the wait-list control group.
Hypothesis 1b: Compared to pre-intervention, wait-list participants will have higher total GSH levels and GSH: GSSG ratios after receiving the intervention.
Aim 2: Examine the effect of a 12-week Hatha yoga program on motor function (gait, balance, strength, flexibility, and physical activity level) and psychosocial well-being (mood, cognitive function, sleep quality, QoL) in individuals with PD.
Hypothesis 2a: Participants in the intervention group will have greater improved scores on the motor Unified Parkinson's Disease Rating Scale (UPDRS), range of motion (ROM), biomechanical force platforms tests, Beck Depression Inventory (BDI), Parkinson's Disease Sleep Scale (PDSS), Parkinson's Disease Quality of Life Questionnaire (PDQUALIF), and Montreal Cognitive Assessment than wait-list participants.
Hypothesis 2b: Compared to pre-intervention, wait-list participants will have improved scores on the motor UPDRS, ROM, biomechanical force platforms tests, BDI, PDSS, and PDQUALIF after receiving the intervention.
Aim 3: Determine the feasibility and acceptability of Hatha yoga program for PD subjects, and fidelity of the yoga program.
Hypothesis 3: The program retention rate will be > 70%, the average attendance rate will be > 70% per class, and no yoga related adverse events will be reported during the study. Most participants will react positively to the yoga program.
Methods Design and Sample A randomized controlled trial design with two groups will be used: a treatment group (n=10) and a wait-list control group (n=10). After randomization, participants in the treatment group will receive 60-minute biweekly Hatha yoga for 12 weeks, and participants in the wait-list group will receive no intervention. Wait-list participants will also serve as their own control and receive the same yoga intervention at the end of 12 weeks when the treatment group completed their program. Participants will be recruited from clinics via flyers, and through local and national PD networks.
Yoga programs that were used in previous PD studies will be incorporated into the design of the proposed intervention program. 19, 31, 32 Two yoga experts who are specialized in musculoskeletal/neurological disorders will review the program. The yoga intervention classes will be taught by a Registered Yoga Teacher. Classes will be held at a community center in St. Louis Park.
Resting blood samples will be collected at the Clinical Translational Science Institute (CTSI) facility by a trained phlebotomist and total GSH and redox status analyzed by a co-investigator. Biomechanical assessment and survey data will be collected in the Konczak laboratory by a trained graduate research assistant. All data will be collected at baseline and 12 weeks from both treatment and wait-list control groups. The 12 weeks data from the wait-list participants will serve as their second baseline before they began the intervention program. Their post intervention data will be collected at 24 weeks post randomization to increase power.
Study Endpoints:
- Primary endpoint: redox status at 12 weeks.
- Secondary endpoint: motor function (gait, balance, strength, flexibility, physical activity level) and psychosocial well-being (mood, cognitive function, sleep quality, QoL) at 12 weeks.
- Tertiary endpoint: yoga feasibility, acceptability, and program fidelity. The sample size of 20, with attrition rate of 20%, has 78% power to detect an effect size of 1.0 when comparing the change before and after the yoga intervention. Both between groups and within group comparisons will be conducted. Descriptive statistics will be used to analyze and report demographic, feasibility, and acceptability data. Inferential statistics (t-test or non-parametric equivalent such as Mann-Whitney, and chi-square test) will be used to analyze the objective and subjective outcomes of Aims 1 \& 2. The α level will be set at ≤ .05.
- Conditions
- Parkinson's Disease
- Being tested
- Hatha yoga
- Keywords
- Yoga, Parkinson's disease, redox status, motor function
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hatha yogaOther
Also called Yoga
Yoga programs that were used in previous PD studies will be incorporated into the design of the proposed intervention program. Two yoga experts who are specialized in musculoskeletal/neurological disorders will review the program. The yoga intervention classes will be taught by a Registered Yoga Teacher. The 60 minute long yoga session will be held twice a week for 12 weeks at a community center in St. Louis Park.
| Study group | Role | What they receive |
|---|---|---|
| Immediate treatment | Experimental | Participants who are randomly assigned to the immediate treatment group will receive 60-minute biweekly Hatha yoga for 12 weeks. Receives: Other: Hatha yoga |
| Waitlist control | Active comparator | Participants who are randomly assigned to the wait-list group will receive no intervention during the first 12 weeks. Not only will they serve as the comparative group, they will also serve as their own control and receive the same yoga intervention at the end of 12 weeks when the immediate treatment group completed their program. Receives: Other: Hatha yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Redox status
The antioxidant glutathione (GSH) and the GSH: glutathione disulfide (GSSG) ratio will be measured at baseline and at the end of the program.
Measured: 12 weeks
Secondary outcomes (8)
Motor function
Gait and strength will be measured using motor Unified Parkinson's Disease Rating Scale (UPDRS) biomechanical force platforms tests: Force plate system (OR6-5 AMTI) - 2D sway path length of center of mass during 20s standing.
Measured: 12 weeks
Motor function
Balance will be measured using the motor UPDRS and biomechanical force platforms tests: Force plate system (OR6-5 AMTI) - range of anterior-posterior and medial-lateral away, total sway area, and duration of one-legged stance.
Measured: 12 weeks
Motor function
Flexibility will be evaluated by measuring range of motion using a goniometer.
Measured: 12 weeks
Cognitive function
Cognitive function will be evaluated using the Montreal Cognitive Assessment test.
Measured: 12 weeks
Mood
Mood will be evaluated using the Beck Depression Inventory scale.
Measured: 12 weeks
Sleep quality
Sleep quality will be evaluated using the Parkinson's Disease Sleep Scale.
Measured: 12 weeks
Physical activity level
Longitudinal Aging Study Amsterdam scale will be used to evaluate physical activity levels in PD subjects.
Measured: 12 weeks
Quality of Life
Parkinson's Disease Quality of Life Questionnaire will be used.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corjena Cheung, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509611
- Sponsor's protocol ID
- 1506M74261
- Acronym
- HYPD
- Status last verified
- Jun 2017
- First submitted
- 20 Jul 2015
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- 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 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. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
PubMed 36602886
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Yoga on Redox Status, Motor Function and Psychosocial Well-being in Individuals With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02509611
- Acronym / sponsor ID
- HYPD / 1506M74261
- Conditions
- Parkinson's Disease
- Keywords
- Yoga, Parkinson's disease, redox status, motor function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 28 Jul 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.
The study's purpose is to assess the effect of yoga on measures of oxidative stress (i.e. reduction-oxidation [redox] status); motor function; and psychosocial well-being, and the feasibility and acceptability of implementing a Hatha yoga program in PD subjects.
Detailed description
The specific aims of this study are:
Aim 1: Determine the effect of a 12-week Hatha yoga program on redox status in individuals with PD.
Hypothesis 1a: Participants in the intervention group will have greater increases in total GSH levels and GSH: GSSG ratios from baseline than participants in the wait-list control group.
Hypothesis 1b: Compared to pre-intervention, wait-list participants will have higher total GSH levels and GSH: GSSG ratios after receiving the intervention.
Aim 2: Examine the effect of a 12-week Hatha yoga program on motor function (gait, balance, strength, flexibility, and physical activity level) and psychosocial well-being (mood, cognitive function, sleep quality, QoL) in individuals with PD.
Hypothesis 2a: Participants in the intervention group will have greater improved scores on the motor Unified Parkinson's Disease Rating Scale (UPDRS), range of motion (ROM), biomechanical force platforms tests, Beck Depression Inventory (BDI), Parkinson's Disease Sleep Scale (PDSS), Parkinson's Disease Quality of Life Questionnaire (PDQUALIF), and Montreal Cognitive Assessment than wait-list participants.
Hypothesis 2b: Compared to pre-intervention, wait-list participants will have improved scores on the motor UPDRS, ROM, biomechanical force platforms tests, BDI, PDSS, and PDQUALIF after receiving the intervention.
Aim 3: Determine the feasibility and acceptability of Hatha yoga program for PD subjects, and fidelity of the yoga program.
Hypothesis 3: The program retention rate will be > 70%, the average attendance rate will be > 70% per class, and no yoga related adverse events will be reported during the study. Most participants will react positively to the yoga program.
Methods Design and Sample A randomized controlled trial design with two groups will be used: a treatment group (n=10) and a wait-list control group (n=10). After randomization, participants in the treatment group will receive 60-minute biweekly Hatha yoga for 12 weeks, and participants in the wait-list group will receive no intervention. Wait-list participants will also serve as their own control and receive the same yoga intervention at the end of 12 weeks when the treatment group completed their program. Participants will be recruited from clinics via flyers, and through local and national PD networks.
Yoga programs that were used in previous PD studies will be incorporated into the design of the proposed intervention program. 19, 31, 32 Two yoga experts who are specialized in musculoskeletal/neurological disorders will review the program. The yoga intervention classes will be taught by a Registered Yoga Teacher. Classes will be held at a community center in St. Louis Park.
Resting blood samples will be collected at the Clinical Translational Science Institute (CTSI) facility by a trained phlebotomist and total GSH and redox status analyzed by a co-investigator. Biomechanical assessment and survey data will be collected in the Konczak laboratory by a trained graduate research assistant. All data will be collected at baseline and 12 weeks from both treatment and wait-list control groups. The 12 weeks data from the wait-list participants will serve as their second baseline before they began the intervention program. Their post intervention data will be collected at 24 weeks post randomization to increase power.
Study Endpoints:
- Primary endpoint: redox status at 12 weeks.
- Secondary endpoint: motor function (gait, balance, strength, flexibility, physical activity level) and psychosocial well-being (mood, cognitive function, sleep quality, QoL) at 12 weeks.
- Tertiary endpoint: yoga feasibility, acceptability, and program fidelity. The sample size of 20, with attrition rate of 20%, has 78% power to detect an effect size of 1.0 when comparing the change before and after the yoga intervention. Both between groups and within group comparisons will be conducted. Descriptive statistics will be used to analyze and report demographic, feasibility, and acceptability data. Inferential statistics (t-test or non-parametric equivalent such as Mann-Whitney, and chi-square test) will be used to analyze the objective and subjective outcomes of Aims 1 \& 2. The α level will be set at ≤ .05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate treatment | Experimental | Other: Hatha yogaParticipants who are randomly assigned to the immediate treatment group will receive 60-minute biweekly Hatha yoga for 12 weeks. |
| Waitlist control | Active comparator | Other: Hatha yogaParticipants who are randomly assigned to the wait-list group will receive no intervention during the first 12 weeks. Not only will they serve as the comparative group, they will also serve as their own control and receive the same yoga intervention at the end of 12 weeks when the immediate treatment group completed their program. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals diagnosed with idiopathic PD;
- On optimized dopaminergic therapy for 4 weeks prior to enrollment; and
- Have not practiced any form of yoga regularly (more than 2 days a week) in the past 6 months; and
- Not currently participating in a supervised exercise program more than 2 days a week
Key exclusion criteria (8 listed)
- Atypical Parkinsonism or other significant brain conditions such as a stroke;
- Fell more than once in the past 3 months;
- Moderate to severe cognitive impairment (scored <26) as indicated by the Montreal Cognitive Assessment;
- Decline in immune function such as pneumonia or systemic infection;
- Spinal fusion or other orthopedic surgery in the past 6 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 |
|---|---|---|
| Hatha yogaAlso: YogaYoga programs that were used in previous PD studies will be incorporated into the design of the proposed intervention program. Two yoga experts who are specialized in musculoskeletal/neurological disorders will review the program. The yoga intervention classes will be taught by a Registered Yoga Teacher. The 60 minute long yoga session will be held twice a week for 12 weeks at a community center in St. Louis Park. | Other | Immediate treatment, Waitlist control |
Primary outcome
Redox status
Time frame: 12 weeks
The antioxidant glutathione (GSH) and the GSH: glutathione disulfide (GSSG) ratio will be measured at baseline and at the end of the program.
8 secondary outcomes
Motor function
Time frame: 12 weeks
Motor function
Time frame: 12 weeks
Motor function
Time frame: 12 weeks
Cognitive function
Time frame: 12 weeks
Mood
Time frame: 12 weeks
Sleep quality
Time frame: 12 weeks
Physical activity level
Time frame: 12 weeks
Quality of Life
Time frame: 12 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 31 May 2018.
- 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 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.
- Individual participant dataSharing planned: No
Related trials for Parkinson's Disease
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
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
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
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.
Corjena Cheung, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hatha yoga in people with Parkinson's Disease, run by University of Minnesota at 1 site in United States.
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 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 31 May 2018. 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 United States. 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?
Redox status (time frame: 12 weeks). 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 NCT02509611, which also lists 2 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 31 May 2018.