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

NCT04237025 | Completed

• 1 other identifier: 20-101-H
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

exercise therapy; mobility limitation; walk test; biomarkers

Outcome Measures

Primary Outcomes (11)

• 10 Meter Walk Test

  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

  Change from baseline gait speed at 6 weeks and at 3 months

• 6-Minute Walk test

  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.

  Change from baseline walking distance at 6 weeks and at 3 months

• Temporal-distance gait measures

  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.

  Change from baseline temporal gait measures at 6 weeks and at 3 months

• Timed Up and Go test (TUG)

  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.

  Change from baseline TUG times at 6 weeks and at 3 months

• Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  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.

  Change from baseline UPDRS score at 6 weeks and at 3 months

• Revised-Freezing of Gait Questionnaire

  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.

  Change from baseline score at 6 weeks and at 3 months.

• Parkinson's Non-Motor Symptom Scale

  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.

  Change from baseline score at 6 weeks and at 3 months.

• Brain-derived neurotrophic factor (BDNF)

  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.

  Change from baseline BDNF levels at 6 weeks and at 3 months.

• Cortisol levels

  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.

  Change from baseline Cortisol levels at 6 weeks and at 3 months.

• α-Amylase

  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.

  Change from baseline α-Amylase levels at 6 weeks and at 3 months.

• Daily Physical Activity

  Average daily steps will be tracked by a Fitbit Inspire HR™ and documented. Average daily steps sampled from one week at baseline, at end of training phase (T-1) and followup phase (T-2).

  Change (average daily steps) from baseline at 6 weeks and at 3 months followup.

Secondary Outcomes (3)

• Parkinson's Fatigue Scale

  Change from baseline score at 6 weeks and at 3 months. .

• Percent Adherence to Independent Nordic Walking Exercise Sessions

  At 3 months post-supervised Nordic Walking training

• Prospective Fall Report

  At 3 months post-supervised Nordic walking training

Study Arms (1)

Nordic walking exercise group

EXPERIMENTAL

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

Interventions

Nordic walking exercise OTHER

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.

Nordic walking exercise group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have a diagnosis of idiopathic Parkinson disease
• Parkinson medications and dosing must be unchanged over the past month
• Must be residing in the community (eg... not supportive living or skilled nursing facility)
• Must have the ability to safely and continuously ambulate a minimum distance of 500 feet independently without an assistive device
• 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
• Must have functional vision with or without corrective lens for safe outdoor mobility

You may not qualify if:

• Must have no other neurologic diagnoses (such as brain injury, multiple sclerosis or stroke)
• 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
• Must not have cognitive impairment as determined by a Montreal Cognitive Assessment score below 21 points
• Must not have had recent deep brain stimulation (DBS) (within last 3 months) or planned DBS in next 4 months
• 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

Sponsors & Collaborators

• Grand Valley State University: lead

Study Sites (1)

Grand Valley State University

Grand Rapids, Michigan, 49503, United States

Location

Related Publications (13)

• Ahlskog JE. Does vigorous exercise have a neuroprotective effect in Parkinson disease? Neurology. 2011 Jul 19;77(3):288-94. doi: 10.1212/WNL.0b013e318225ab66.

  PMID: 21768599 BACKGROUND

• Flach A, Jaegers L, Krieger M, Bixler E, Kelly P, Weiss EP, Ahmad SO. Endurance exercise improves function in individuals with Parkinson's disease: A meta-analysis. Neurosci Lett. 2017 Oct 17;659:115-119. doi: 10.1016/j.neulet.2017.08.076. Epub 2017 Sep 1.

  PMID: 28870627 BACKGROUND

• Ahlskog JE. Aerobic Exercise: Evidence for a Direct Brain Effect to Slow Parkinson Disease Progression. Mayo Clin Proc. 2018 Mar;93(3):360-372. doi: 10.1016/j.mayocp.2017.12.015.

  PMID: 29502566 BACKGROUND

• Uc EY, Doerschug KC, Magnotta V, Dawson JD, Thomsen TR, Kline JN, Rizzo M, Newman SR, Mehta S, Grabowski TJ, Bruss J, Blanchette DR, Anderson SW, Voss MW, Kramer AF, Darling WG. Phase I/II randomized trial of aerobic exercise in Parkinson disease in a community setting. Neurology. 2014 Jul 29;83(5):413-25. doi: 10.1212/WNL.0000000000000644. Epub 2014 Jul 2.

  PMID: 24991037 BACKGROUND

• Bombieri F, Schena F, Pellegrini B, Barone P, Tinazzi M, Erro R. Walking on four limbs: A systematic review of Nordic Walking in Parkinson disease. Parkinsonism Relat Disord. 2017 May;38:8-12. doi: 10.1016/j.parkreldis.2017.02.004. Epub 2017 Feb 6.

  PMID: 28202374 BACKGROUND

• Cugusi L, Manca A, Dragone D, Deriu F, Solla P, Secci C, Monticone M, Mercuro G. Nordic Walking for the Management of People With Parkinson Disease: A Systematic Review. PM R. 2017 Nov;9(11):1157-1166. doi: 10.1016/j.pmrj.2017.06.021. Epub 2017 Jul 8.

  PMID: 28694221 BACKGROUND

• Skorkowska-Telichowska K, Kropielnicka K, Bulinska K, Pilch U, Wozniewski M, Szuba A, Jasinski R. Nordic walking in the second half of life. Aging Clin Exp Res. 2016 Dec;28(6):1035-1046. doi: 10.1007/s40520-016-0531-8. Epub 2016 Jan 23.

  PMID: 26803510 BACKGROUND

• Monteiro EP, Franzoni LT, Cubillos DM, de Oliveira Fagundes A, Carvalho AR, Oliveira HB, Pantoja PD, Schuch FB, Rieder CR, Martinez FG, Peyre-Tartaruga LA. Effects of Nordic walking training on functional parameters in Parkinson's disease: a randomized controlled clinical trial. Scand J Med Sci Sports. 2017 Mar;27(3):351-358. doi: 10.1111/sms.12652. Epub 2016 Feb 2.

  PMID: 26833853 BACKGROUND

• Petzinger GM, Fisher BE, McEwen S, Beeler JA, Walsh JP, Jakowec MW. Exercise-enhanced neuroplasticity targeting motor and cognitive circuitry in Parkinson's disease. Lancet Neurol. 2013 Jul;12(7):716-26. doi: 10.1016/S1474-4422(13)70123-6.

  PMID: 23769598 BACKGROUND

• Hirsch MA, van Wegen EEH, Newman MA, Heyn PC. Exercise-induced increase in brain-derived neurotrophic factor in human Parkinson's disease: a systematic review and meta-analysis. Transl Neurodegener. 2018 Mar 20;7:7. doi: 10.1186/s40035-018-0112-1. eCollection 2018.

  PMID: 29568518 BACKGROUND

• Soares NM, Pereira GM, Altmann V, de Almeida RMM, Rieder CRM. Cortisol levels, motor, cognitive and behavioral symptoms in Parkinson's disease: a systematic review. J Neural Transm (Vienna). 2019 Mar;126(3):219-232. doi: 10.1007/s00702-018-1947-4. Epub 2018 Oct 29.

  PMID: 30374595 BACKGROUND

• Smyth N, Skender E, David FJ, Munoz MJ, Fantuzzi G, Clow A, Goldman JG, Corcos DM. Endurance exercise reduces cortisol in Parkinson's disease with mild cognitive impairment. Mov Disord. 2019 Aug;34(8):1238-1239. doi: 10.1002/mds.27719. Epub 2019 May 20. No abstract available.

  PMID: 31107979 BACKGROUND

• Masters JM, Noyce AJ, Warner TT, Giovannoni G, Proctor GB. Elevated salivary protein in Parkinson's disease and salivary DJ-1 as a potential marker of disease severity. Parkinsonism Relat Disord. 2015 Oct;21(10):1251-5. doi: 10.1016/j.parkreldis.2015.07.021. Epub 2015 Jul 23.

  PMID: 26231472 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Mobility Limitation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Physical Therapy

Model Details: 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.

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 22, 2020
• Study Start: February 15, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)