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Effects of Nordic Walking Exercise on Gait, Motor/Non-motor Symptoms, and Exercise Biomarkers in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT04237025
Recruitment Status : Not yet recruiting
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Cathy Harro, Grand Valley State University

Brief Summary:

The purpose of this study is to examine the effects of Nordic pole walking exercise on walking function, movement and non-movement Parkinson-related symptoms, and certain exercise-related chemical indicators (bio-markers) in people with Parkinson's disease.

This study will examine both the immediate and long-term effects of Nordic walking (NW) exercise on walking function, PD symptoms and exercise bio-markers after a supervised and individually progressed 6-week NW exercise training period and after a 3-month independent NW exercise phase.

NW, as a task- specific exercise with higher energy demands than regular walking, has good practicality for independent walking exercise once the training program is completed. Therefore, this study will also examine independent NW exercise engagement after a supervised training program to assess feasibility and sustainability of this mode of task-specific aerobic exercise.


Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Nordic walking exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Intervention Model Description:

This study will employ a prospective, single cohort pre- and post-intervention research design. Supervised and individually prescribed Nordic Walking (NW) exercise will be conducted in a small group setting with a 2:1 participant to trainer ratio providing individualized instruction and progression of training. Training will be conducted for a total of 14 one-hour sessions over a 6-week period.

In addition to the supervised NW training sessions, participants will be asked to complete independent NW exercise at least 2 times weekly during the 6-week training period. Following the completion of the 6-week supervised NW training period, participants will be asked to independently continue their NW exercise as least three times per week for the 3-month follow-up period. Independent NW exercise logs and adherence will be monitored during both the supervised training phase and the 3-month follow-up phase.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Nordic Walking Exercise on Gait, Motor/Non-motor Symptoms, and Exercise Biomarkers in Individuals With Parkinson's Disease
Estimated Study Start Date : February 15, 2020
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nordic walking exercise group
Supervised Nordic walking exercise training 3 times per week for the first two weeks and 2 times per week for next four weeks (total 6 weeks). In addition to independent Nordic walking exercise twice weekly during intervention phase and three times weekly during the 3-month followup phase.
Other: Nordic walking exercise
Supervised Nordic Walking (NW) exercise will be conducted in a small group setting with a 2:1 participant to trainer ratio providing individualized training instruction. Training will be conducted for a total of 14 one-hour sessions over a 6-week period. Training will take place at an outdoor community track with progression tasks on hills or grassy terrain. The one-hour training sessions will include a 10-minute warm-up period, 45 minutes of individualized NW training, and a 5-minute cool down period. The target training duration goal for NW exercise will be 45 minutes of continuous walking at moderate intensity based on target heart rate and Rating of Perceived Exertion. NW exercise program will be customized and progressed for each participant by trainers with ongoing assessment of participant's gait pattern, NW technique, and exercise responses during the training sessions. Group comradery and accountability will be facilitated through training in small group training context.




Primary Outcome Measures :
  1. 10 Meter Walk Test [ Time Frame: Change from baseline gait speed at 6 weeks and at 3 months ]
    Comfortable and fast gait speed (m/s) conducted on measured level walkway using standardized procedures. 10-Meter walk test is the gold standard for assessment of the effectiveness of walking training interventions in PD

  2. 6-Minute Walk test [ Time Frame: Change from baseline walking distance at 6 weeks and at 3 months ]
    Measures walking distance (m) using standardized 100 ft. walkway and procedures from American Thoracic Society. Measure reflects walking endurance and sub-maximal cardiovascular endurance. 6-Minute Walk test is a valid and reliable measure of walking function in persons with PD.

  3. Temporal-distance gait measures [ Time Frame: Change from baseline temporal gait measures at 6 weeks and at 3 months ]
    Computerized assessment of temporal gait measures: stride length, cadence, stride time variability. These gait measures are sensitive indicators of gait dysfunction in persons with Parkinson disease. This study will assess if Nordic walking exercise improves gait pattern and efficiency.

  4. Timed Up and Go test (TUG) [ Time Frame: Change from baseline TUG times at 6 weeks and at 3 months ]
    Timed Up & Go test and the Cognitive-TUG and Motor-TUG timed tests (seconds) are sensitive functional mobility and dual task measures in Parkinson disease. Dual task TUG measure has excellent specificity and sensitivity to identify fall risk in Parkinson disease.

  5. Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [ Time Frame: Change from baseline UPDRS score at 6 weeks and at 3 months ]
    The MDS-UPDRS is the gold standard for assessing disease severity in PD and is commonly used to measure treatment effectiveness. In this study the MDS-UPDRS will be used to assess motor and non-motor symptoms.

  6. Revised-Freezing of Gait Questionnaire [ Time Frame: Change from baseline score at 6 weeks and at 3 months. ]
    The revised Freezing of Gait Questionnaire will be administered to determine if participant is experiencing any freezing and if so, the frequency, severity and impact of freezing on their daily mobility. Minimum score=0; Maximum score=24; higher score reflects more severe freezing of gait.

  7. Parkinson's Non-Motor Symptom Scale [ Time Frame: Change from baseline score at 6 weeks and at 3 months. ]
    The Parkinson Non-Motor Symptom Scale is a self-report questionnaire used to assess the non-motor symptoms experienced by the individual during the past month. This is a valid measure of the effects of non-motor symptoms on daily function.Minimum score=0; Maximum score= 360; higher score is worse, reflects more symptoms.

  8. Brain-derived neurotrophic factor (BDNF) [ Time Frame: Change from baseline BDNF levels at 6 weeks and at 3 months. ]
    BDNF will be analyzed as a bio-marker to evaluate the potential neuro-protective effects of exercise in PD. Blood samples will be collected and both serum and plasma BDNF levels will be analyzed. Serum or plasma BDNF levels are currently used as proxy for BDNF central expression due to the difficulty to measure the levels in Central Nervous System.

  9. Cortisol levels [ Time Frame: Change from baseline Cortisol levels at 6 weeks and at 3 months. ]
    Cortisol levels are measured as exercise bio-markers. Cortisol levels may be reflective of stress and are related to neuro-inflammatory response in the nervous system. Saliva samples will be collected and analyzed for cortisol levels. Cortisol levels may be used as non-invasive stress-related bio-markers to gauge the effects of NW in persons with PD.

  10. α-Amylase [ Time Frame: Change from baseline α-Amylase levels at 6 weeks and at 3 months. ]
    α-Amylase will be analyzed as an exercise bio-marker. Reduced salivary α-amylase reflective of decreased stress reactivity has been reported after exercise intervention. α-Amylase are valuable non-invasive stress-related bio-markers to gauge the effects of NW in persons with PD.


Secondary Outcome Measures :
  1. Parkinson's Fatigue Scale [ Time Frame: Change from baseline score at 6 weeks and at 3 months. . ]
    Parkinson Fatigue Scale is a standardized questionnaire that assesses fatigue and its impact on daily function in individuals with PD. This tool will be used as secondary measure of any change in nonmotor symptoms following Nordic walking exercise. Minimum score=10; Maximum score=80; higher score is worse reflecting more severe fatigue symptoms

  2. Percent Adherence to Independent Nordic Walking Exercise Sessions [ Time Frame: At 3 months post-supervised Nordic Walking training ]
    Participants' completed Activity logs and use of activity monitors will be used to document and analyze exercise adherence (frequency, duration, intensity, and distance) of their NW weekly independent exercise and daily total number of steps. These measures will be reflective of NW adherence following supervised training period in the 3-month follow-up phase of the study.

  3. Prospective Fall Report [ Time Frame: At 3 months post-supervised Nordic walking training ]
    Participants will complete a monthly fall calendar to document any falls and near falls during the study duration. Prospective fall calendars are the gold standard for fall tracking and evidence shows that patients often forget and under-report falls when using a retrospective recall method. Fall report during the 3-month follow-up phase will be used to assess adverse events and safety of independent NW exercise in this sample.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must have a diagnosis of idiopathic Parkinson disease
  2. Parkinson medications and dosing must be unchanged over the past month
  3. Must be residing in the community (eg... not supportive living or skilled nursing facility)
  4. Must have the ability to safely and continuously ambulate a minimum distance of 500 feet independently without an assistive device
  5. Must have the ability to ascend and descend a full flight of stairs with or without the use of railings with no more than stand by assistance
  6. Must have functional vision with or without corrective lens for safe outdoor mobility

Exclusion Criteria:

  1. Must have no other neurologic diagnoses (such as brain injury, multiple sclerosis or stroke)
  2. Must have no significant comorbidities (cardiorespiratory conditions, orthopedic conditions, or recent orthopedic surgery) that would limit their ability to safely participate in an intensive walking exercise program
  3. Must not have cognitive impairment as determined by a Montreal Cognitive Assessment score below 21 points
  4. Must not have had recent deep brain stimulation (DBS) (within last 3 months) or planned DBS in next 4 months
  5. Must not be previously trained in Nordic Walking technique And are currently engaged in moderate intensity Nordic Walking exercise at least 3 days per week

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04237025


Contacts
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Contact: Cathy C Harro, DPT, MS 616-331-5974 harroc@gvsu.edu
Contact: Sok Kean Khoo, PhD 616-331-5916 khoos@gvsu.edu

Sponsors and Collaborators
Grand Valley State University
Investigators
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Principal Investigator: Cathy C Harro, DPT, MS Grand Valley State University
Principal Investigator: Sok Kean Khoo, PhD Grand Valley State University
Principal Investigator: Michael Shoemaker, DPT, PhD Grand Valley State University
  Study Documents (Full-Text)

Documents provided by Cathy Harro, Grand Valley State University:
Informed Consent Form  [PDF] December 13, 2019


Publications:

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Responsible Party: Cathy Harro, Associate Professor, Physical Therapy, Grand Valley State University
ClinicalTrials.gov Identifier: NCT04237025    
Other Study ID Numbers: 20-101-H
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This proof of concept study is planned as a first step in examining effects of Nordic Walking on both functional and bio-marker outcomes; and will lay the foundation our next stage of research on this intervention.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cathy Harro, Grand Valley State University:
exercise therapy
mobility limitation
walk test
biomarkers
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases