Resistance TrainingNCT05513534
Mindfulness and Yoga or Resistance Exercise Training Fpr Parkinson's Patients
A study testing Yoga and High-speed Resistance Training in people with Resistance Training and Yoga, run by University of Miami at 1 site in United States.
Trial summary
The investigators propose to compare the effects of a 16-week specially designed yoga program to a power-based resistance training program on affect trait mindfulness, anxiety, depression, functionality, and quality of life. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Resistance Training, Yoga
- What is being tested?
- Yoga and High-speed Resistance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2022to 15 Dec 2022
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with mild to moderate PD [Hoehn and Yahr (H\&Y) stage 1-3];
- over 50 years of age;
- stable use of medication;
- able to walk 15 m independently with or without an assistive device;
- the ability to get up and down from the floor with minimal assistance;
- not currently participating in yoga or resistance training more than one time per week;
- able to understand and communicate in English; and,
- able to provide informed consent.
Who cannot join
- cognitive impairment as designated by a score of less than 23 on the Montreal Cognitive Assessment (MoCA)]; and,
- any clinically significant medical condition, such as cardiopulmonary disease and musculoskeletal problems. Subjects providing affirmative answers on a Physical Activity Readiness Questionnaire (PAR-Q) or Health Status Questionnaire related to cardiopulmonary disease or musculoskeletal impairments will be required to present a physical activity clearance from their physician.
Trial locations and contacts
1 site in 1 country.
United States1 site
Laboratory of Neruomuscular Research and Active Aging
Coral Gables, Florida, 33147
About this study
Official title: The Effects of Yoga and Power Training on Mindfulness, Psychological Wellbeing, and Functional Ability of Individuals With Parkinson's Disease.
The investigators propose to compare the effects of a 16-week specially designed yoga program to a power-based resistance training program on affect trait mindfulness, anxiety, depression, functionality, and quality of life. As secondary measures, we propose to compare the effects of these exercise programs on measures of executive function (EF), sleep, disease stage, motor symptoms, muscle quality, rigidity, strength, power, and mobility.
Read the detailed description
Yoga has long been recognized as a therapeutic intervention for improving mindfulness and psychological well-being. Yoga represents a unique exercise activity that employs mindfulness-based practices and various balance postures to improve physical and mental health. Yoga is a gentle form of exercise that can be easily adapted to populations suffering from physical and mental limitations and has been shown to improve physical and psychological functioning in individuals with PD. Though research continues to support the positive psychological effects of yoga, it is unclear whether this is due to the unique mindfulness-rooted approach of yoga or general increases in physical activity.
Power-based resistance training has had promising results in the PD community. Improvements in balance, gait, and increases in leg muscle power and strength have been shown in PD patients after power training interventions. Although power training is a beneficial exercise modality in the treatment of motor symptoms, the effects of power training on nonmotor symptoms have yet to be established.
- Conditions
- Resistance Training, Yoga
- Being tested
- Yoga, High-speed Resistance Training
- Keywords
- Parkinson's disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
A standard yoga program will be provided using Hatha poses.
High-speed Resistance TrainingOther
Each session will consist of three sets of 10 repetitions each with 1.5 to 2-minute rest periods between sets. Participants will be instructed to control the concentric and eccentric velocity of each exercise, with each phase lasting approximately two to three seconds
| Study group | Role | What they receive |
|---|---|---|
| Standard Hatha Yoga | Experimental | A yoga program adapted for those with PD will be used in the current study. It will be conducted over a 16-week period and consists of twice-weekly sessions lasting approximately one hour. The program will be based on principles of Hatha yoga which incorporate longer holds and deep breathing. Each session will include a warm-up, three yoga flows, a balance training section, and a cooldown phase. The first four weeks will emphasize proper alignment, breathing, and technique. Additionally, the classes will be led by a certified yoga instructor and include multiple on-site assistants to ensure a safe training environment. Participants will also be provided with assistive devices (i.e. chairs, yoga blocks, and blankets) if they are required. Receives: Other: Yoga |
| Power Resisatnce Training | Experimental | : A high-velocity resistance (power) will be conducted over a 16-week period and consists of twice-weekly sessions lasting approximately one hour. Each training session will begin with a brief warm-up. Each session will consist of three sets of 10 repetitions each with 1.5 to 2- to minute rest periods between sets. Participants will be instructed to control the concentric and eccentric velocity of each exercise, with each phase lasting approximately two to three seconds. Exercise order will be randomized during each session and upper and lower body exercises will be alternated whenever possible. Receives: Other: High-speed Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parkinson's Disease Questionnaire (PDQ-39)
The PDQ-39 is one of the most widely used self-reported questionnaires designed to assess QoL in Parkinson's patients. It is composed of 39 items which are distributed over 8 separate scales including mobility, activities of daily living, emotional wellbeing, stigma, social support, cognition, communication, and bodily discomfort (Jenkinson et al., 1997). All items are answered on a 5-point Likert type scale (0= never, 1=occasionally, 2=sometimes, 3=often, 4=always). In addition, a summary index can be computed to assess the overall impact of PD on the responder.
Measured: 15 minutes
Parkinson Anxiety Scale (PAS)
The Parkinson Anxiety Scale (PAS) is a frequently used observer or patient-rated anxiety measurement tool designed specifically for PD patients. The exam consists of three sub-scales for persistent anxiety (dimension A), episodic anxiety (dimension B), and avoidance behavior (dimension C), with 5, 4, and 3 items, respectively. All items are scored on a 5-point Likert type scale (0=not or never, 4=severe or almost always). A cut-off point of 14 is optimal to detect anxiety. Self-administered, the test takes approximately 2 minutes.
Measured: 2 minutes
Beck Depression Inventory
The Beck Depression Inventory is a widely used self-report inventory to assess the severity of depressive symptoms in adults in the past two weeks. The BDI-II has been validated in patients with PD. It includes both cognitive and somatic symptoms of depression and consists of 21 items using a 4-point Likert scale. A maximum score is 63 with 0-13 indicating none or minimal range depression, 14-19 mild, 20-28 moderate, and 29-63 severe.
Measured: 5 minutes
Mindful Attention Awareness Scale (MAAS)
The Mindful Attention Awareness Scale is a single-factor measure of trait mindfulness comprised of 15 items. The scale evaluates attentiveness and awareness of the present moment with higher scores indicating a greater degree of mindfulness trait. All questions are answered on a 6-point Likert scale with a range from 1 to 6. The total possible score is 90 points with a minimum score of 15
Measured: 5 minutes
Secondary outcomes (10)
One-repetition maximum (1RM) testing
One-repetition maximum (1RM) strength testing will include leg press and chest press. After a warm-up, the subject do 10 repetitions a low resistance. The test will begin using a weight near the predicted maximum. The weight will then be increased or decreased depending on the subject's ability to perform the repetition using correct technique.
Measured: 10 minutes
Timed Up & Go (TUG)
The TUG is a widely used clinical assessment for measuring fall risk and functional mobility. The test begins with participants sitting with their spines against a chair back and their hands on their laps. Upon verbal cue, subjects stand up, walk around a cone placed three meters from the front edge of the chair and then return to their seated position. The participants will be timed as they complete the task as quickly as possible. Each participant will perform one familiarization trial and two test trials, with at least a one-minute recovery between trials.
Measured: 3 minutes
Quantitative Gait Assessment
Three-dimensional movement analysis of subjects gait patterns during a 10-meter walk.
Measured: 5 minutes
Isokinetic Testing
The Biodex 4 Dynamometer will be used for all isokinetic testing. Subjects will be asked to perform an isokinetic warm-up of 10 repetitions of leg extension at 270 deg/s, be given a three-minute recovery, and then perform three maximal isokinetic quadriceps extensions at 90, 180, and 300 degrees/second using 2-minute recoveries in between sets. All results will be recorded. The repetitions producing the highest peak torque among the three efforts, and the average power for the repetitions will be used for statistical evaluation. Given the nature of isokinetic testing the resistance is at the speeds we have chosen, far below maximum.
Measured: 30 minutes
Ultrasound
Ultrasound images of the quadriceps femoris muscle (vastus medialis, vastus lateralis, vastus intermedius, rectus femoris) will be taken on the thigh at the two-thirds and midpoint of the length between the anterior superior iliac spine and the upper border of the patella. A LOGIQ P9 R3 Ultrasound System (GE Healthcare, Buckinghamshire, UK) and 3-12 MHz linear array transducer probe will be used, and testing will be conducted on a padded treatment table. Care will be taken to maintain the same standardized body positions and probe locations for all participants. Minimal pressure will be applied by the researcher to reduce any tissue compression that would artificially influence the results. Before acquiring measurements, subjects will rest on the examination table for five minutes to avoid any potential movement-induced stiffness. To improve acoustic contact between the probe and skin, a water-soluble transmission gel will be used on the head of the probe.
Measured: 20 minutes
Power Testing
ower testing will begin with a warm-up of 10 repetitions at 30% 1RM, followed by a 1-minute recovery period. A second warm-up of 5 repetitions at 30% 1RM will then be performed as rapidly as possible. Peak muscle power will then be assessed at 8 relative intensities (40, 50, 60, 70, and 80% 1RM) on the same resistance machines used for strength testing. The percentages will be randomized to reduce any order effect. For each repetition, the concentric phase will be performed as fast as possible, and the eccentric phase will be performed over 2-3 seconds. Each repetition will be verbally cued "3.2.1. Go!" This testing protocol is commonly used for power testing.34,35 Any repetition not performed properly will be repeated after a 1-minute break. Power output will be recorded from the display of each machine and cross-referenced with the electronic spreadsheets.
Measured: 15 minutes
The Stroop Color Word Test
The Stroop color word test is another commonly used neurophysiological assessment which evaluates the participant's ability to inhibit cognitive inference. This cognitive domain is associated with EF and involves the processing of a stimulus where one feature of a previous stimulus may affect the simultaneous processing of a new stimulus. Typically, the test requires an individual to name the color of ink of color words printed in incongruent colors (incongruent condition), for example, the word "red" is printed in green ink. Participants must also complete a control task, where they read a color name printed in black ink and identify colored rectangles that correspond to that color as quickly as possible (congruent condition).
Measured: 5 minutes
Trail-making Test (TNT)
The TMT is yet another frequently used neurophysiological assessment which examines visuospatial abilities, working memory and task switching abilities associated with executive function domains. The test is separated into two different assessments, part A and part B. Both tasks incorporate 25 circles distributed across a white sheet of paper. In part A, the circles are numbered from 1 to 25. In part B, the participant is presented with alternating numbers and letters. Both tasks require the participant to connect the circles with lines in ascending order as quickly as possible. It has been shown that TMT Part A is associated with EF domains of visuospatial abilities, whereas part B is associated with working memory and response inhibition. Those with PD have demonstrated decreased scores on both the TMT part A and B indicating executive function decrements.
Measured: 5 minutes
Home Sleep Testing
Study participants will have a home sleep study using the NoxA1 system that allows for monitoring of sleep (i.e., EEG) along with respiratory effort and oxygen saturation. The goal of the home sleep study is to exclude other respiratory-related sleep disorders.
Measured: 8 hours
Actigraphy
An actigraph will be worn on the wrist for seven consecutive 24-hour periods, to collect data on habitual sleep duration. Wrist actigraphy is a technique for measuring movement over an extended recording period (days to weeks). Data garnered from wrist actigraphy will be used to derive variables such as habitual total sleep time, number and duration of awakenings per night, and napping behavior.
Measured: 168 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start18 Aug 2022
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistance TrainingStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will compare Yoga and circuit resistance tarining impacts on mindfulness, anxiety, cognition, muscle structure, and physical performance in people with Parkinson's disease.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Signorile, University of Miami
- Investigators
- Joseph F Signorile, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513534
- Sponsor's protocol ID
- 20220477
- Status last verified
- Dec 2023
- First submitted
- 22 Aug 2022
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Yoga and Power Training on Mindfulness, Psychological Wellbeing, and Functional Ability of Individuals With Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT05513534
- Acronym / sponsor ID
- 20220477
- Conditions
- Resistance Training, Yoga
- Keywords
- Parkinson's disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 24 Aug 2022 (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.
The investigators propose to compare the effects of a 16-week specially designed yoga program to a power-based resistance training program on affect trait mindfulness, anxiety, depression, functionality, and quality of life. As secondary measures, we propose to compare the effects of these exercise programs on measures of executive function (EF), sleep, disease stage, motor symptoms, muscle quality, rigidity, strength, power, and mobility.
Detailed description
Yoga has long been recognized as a therapeutic intervention for improving mindfulness and psychological well-being. Yoga represents a unique exercise activity that employs mindfulness-based practices and various balance postures to improve physical and mental health. Yoga is a gentle form of exercise that can be easily adapted to populations suffering from physical and mental limitations and has been shown to improve physical and psychological functioning in individuals with PD. Though research continues to support the positive psychological effects of yoga, it is unclear whether this is due to the unique mindfulness-rooted approach of yoga or general increases in physical activity.
Power-based resistance training has had promising results in the PD community. Improvements in balance, gait, and increases in leg muscle power and strength have been shown in PD patients after power training interventions. Although power training is a beneficial exercise modality in the treatment of motor symptoms, the effects of power training on nonmotor symptoms have yet to be established.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- We will compare Yoga and circuit resistance tarining impacts on mindfulness, anxiety, cognition, muscle structure, and physical performance in people with Parkinson's disease.
| Arm | Type | Receives |
|---|---|---|
| Standard Hatha Yoga | Experimental | Other: YogaA yoga program adapted for those with PD will be used in the current study. It will be conducted over a 16-week period and consists of twice-weekly sessions lasting approximately one hour. The program will be based on principles of Hatha yoga which incorporate longer holds and deep breathing. Each session will include a warm-up, three yoga flows, a balance training section, and a cooldown phase. The first four weeks will emphasize proper alignment, breathing, and technique. Additionally, the classes will be led by a certified yoga instructor and include multiple on-site assistants to ensure a safe training environment. Participants will also be provided with assistive devices (i.e. chairs, yoga blocks, and blankets) if they are required. |
| Power Resisatnce Training | Experimental | Other: High-speed Resistance Training: A high-velocity resistance (power) will be conducted over a 16-week period and consists of twice-weekly sessions lasting approximately one hour. Each training session will begin with a brief warm-up. Each session will consist of three sets of 10 repetitions each with 1.5 to 2- to minute rest periods between sets. Participants will be instructed to control the concentric and eccentric velocity of each exercise, with each phase lasting approximately two to three seconds. Exercise order will be randomized during each session and upper and lower body exercises will be alternated whenever possible. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- diagnosed with mild to moderate PD [Hoehn and Yahr (H\&Y) stage 1-3];
- over 50 years of age;
- stable use of medication;
- able to walk 15 m independently with or without an assistive device;
- the ability to get up and down from the floor with minimal assistance;
Key exclusion criteria (2 listed)
- cognitive impairment as designated by a score of less than 23 on the Montreal Cognitive Assessment (MoCA)]; and,
- any clinically significant medical condition, such as cardiopulmonary disease and musculoskeletal problems. Subjects providing affirmative answers on a Physical Activity Readiness Questionnaire (PAR-Q) or Health Status Questionnaire related to cardiopulmonary disease or musculoskeletal impairments will be required to present a physical activity clearance from their physician.
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 |
|---|---|---|
| YogaA standard yoga program will be provided using Hatha poses. | Other | Standard Hatha Yoga |
| High-speed Resistance TrainingEach session will consist of three sets of 10 repetitions each with 1.5 to 2-minute rest periods between sets. Participants will be instructed to control the concentric and eccentric velocity of each exercise, with each phase lasting approximately two to three seconds | Other | Power Resisatnce Training |
Primary outcome
Parkinson's Disease Questionnaire (PDQ-39)
Time frame: 15 minutes
The PDQ-39 is one of the most widely used self-reported questionnaires designed to assess QoL in Parkinson's patients. It is composed of 39 items which are distributed over 8 separate scales including mobility, activities of daily living, emotional wellbeing, stigma, social support, cognition, communication, and bodily discomfort (Jenkinson et al., 1997). All items are answered on a 5-point Likert type scale (0= never, 1=occasionally, 2=sometimes, 3=often, 4=always). In addition, a summary index can be computed to assess the overall impact of PD on the responder.
Parkinson Anxiety Scale (PAS)
Time frame: 2 minutes
The Parkinson Anxiety Scale (PAS) is a frequently used observer or patient-rated anxiety measurement tool designed specifically for PD patients. The exam consists of three sub-scales for persistent anxiety (dimension A), episodic anxiety (dimension B), and avoidance behavior (dimension C), with 5, 4, and 3 items, respectively. All items are scored on a 5-point Likert type scale (0=not or never, 4=severe or almost always). A cut-off point of 14 is optimal to detect anxiety. Self-administered, the test takes approximately 2 minutes.
Beck Depression Inventory
Time frame: 5 minutes
The Beck Depression Inventory is a widely used self-report inventory to assess the severity of depressive symptoms in adults in the past two weeks. The BDI-II has been validated in patients with PD. It includes both cognitive and somatic symptoms of depression and consists of 21 items using a 4-point Likert scale. A maximum score is 63 with 0-13 indicating none or minimal range depression, 14-19 mild, 20-28 moderate, and 29-63 severe.
Mindful Attention Awareness Scale (MAAS)
Time frame: 5 minutes
The Mindful Attention Awareness Scale is a single-factor measure of trait mindfulness comprised of 15 items. The scale evaluates attentiveness and awareness of the present moment with higher scores indicating a greater degree of mindfulness trait. All questions are answered on a 6-point Likert scale with a range from 1 to 6. The total possible score is 90 points with a minimum score of 15
10 secondary outcomes
One-repetition maximum (1RM) testing
Time frame: 10 minutes
Timed Up & Go (TUG)
Time frame: 3 minutes
Quantitative Gait Assessment
Time frame: 5 minutes
Isokinetic Testing
Time frame: 30 minutes
Ultrasound
Time frame: 20 minutes
Power Testing
Time frame: 15 minutes
The Stroop Color Word Test
Time frame: 5 minutes
Trail-making Test (TNT)
Time frame: 5 minutes
Home Sleep Testing
Time frame: 8 hours
Actigraphy
Time frame: 168 hours
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 22 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Joseph F Signorile, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga and High-speed Resistance Training in people with Resistance Training and Yoga, run by University of Miami 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 8 inclusion and 2 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 22 Dec 2023. 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?
Parkinson's Disease Questionnaire (PDQ-39) (time frame: 15 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2023.