Parkinson DiseaseWalkingNCT03355521
Effects of Nordic Walking in Parkinson Disease Patients
A study testing Nordic Walking and Free Walking in people with Parkinson Disease and Parkinson Disease 10, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
The aim of this study was to evaluate and compare the effects of a Nordic and free walking training program on clinical, functional and biomechanical parameters of gait, in people with PD. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease, Parkinson Disease 10
- What is being tested?
- Nordic Walking and Free Walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Mar 2013to 30 Jul 2014
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Show chronic pain or presence of a migraine or nausea in daily life;
- History of labyrinthitis;
- Deep Brain Stimulation (DBS);
- The frequency of training below of 75%.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90690-200
About this study
Official title: Effects of Nordic Walking Training on Functional, Clinical and Biomechanics Parameters in Parkinson's Disease: a Randomized Controlled Clinical Trial
The aim of this study was to evaluate and compare the effects of a Nordic and free walking training program on clinical, functional and biomechanical parameters of gait, in people with PD.
Outcomes: Motor symptoms: Staging and severity of PD, balance, walking functional mobility, self-selected walking velocity, and rehabilitation index. Non-Motor symptoms: Cognitive function, depressive symptoms, and quality of life (QL). Outcomes Biomechanics: Kinematic parameters (spatiotemporal and dynamic stability of walking) and neuromuscular parameters (amplitude of the electromyography signal, initial and final activation threshold, activation time and co-contraction index, of the following muscles: Vastus Lateralis (VL), Biceps Femoris (BF), Tibialis Anterior (TA), Gastrocnemius Medialis (GM).
Read the detailed description
Introduction: Changes in clinical, functional and biomechanical parameters of gait are remarkable features in Parkinson's disease (PD). Such changes are disabling for the performance of daily living activities (DLAs) as they represent a high risk of falls and impair quality of life (QL) in this population. Although exercise is recommended as an effective model of therapeutic intervention, to minimize the symptoms of this disease, little is known about the effects of Nordic walking on motor and non-motor symptoms in patients with PD. Purpose: The aim of this study was to evaluate and compare the effects of a Nordic and free walking training program on clinical, functional and biomechanical parameters of gait, in people with PD. Experimental Design: Randomized controlled clinical trial (RCT). Study Site: Physical Education School of the Federal University of Rio Grande do Sul and the Clinical Hospital of Porto Alegre, in Porto Alegre, Rio Grande do Sul, Brazil. Methods: The sample comprised 33 participants, aged above 50 years, of both sexes, with a clinical diagnosis of idiopathic PD, with the staging of 1-4 in the Hoehn and Yahr scale (H\&Y). The participants received two types of intervention: Nordic walking training program (NW, n = 16) and free walking training program (FW, n = 17), during six weeks. Aiming to evaluate the effects of the training program, the participants underwent the tests in the following period: pre-training + pre-familiarization (T1); post-familiarization + pre-training (T2); post-training (T3).
- Conditions
- Parkinson Disease, Parkinson Disease 10
- Being tested
- Nordic Walking, Free Walking
- Keywords
- functionality, gait, kinematics, electromyographic activity, depressive symptoms, quality of life
- Medical subject headings
- Parkinson Disease, Parkinson Disease 10, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nordic WalkingOther
Nordic walking Training the total period of training was composed by 9-week of walking with poles, two sessions per week. The cycles were divided into four microcycles composed of three training sessions. Each training session took 60 min. Free walking aerobics training was used during the training period. These exercises were performed alternating volume and intensity. The training session was divided into three stages: (a) stretching, joint mobility, and heating; (b) main part (FW); (c) return to the calm and ultimate stretching.
Free WalkingOther
Free walking Training The total period of training was composed by 9-week of walking without poles, two sessions per week. The cycles were divided into four microcycles composed of three training sessions. Each training session took 60 min. Free walking aerobics training was used during the training period. These exercises were performed alternating volume and intensity. The training session was divided into three stages: (a) stretching, joint mobility, and heating; (b) main part (FW); (c) return to the calm and ultimate stretching.
| Study group | Role | What they receive |
|---|---|---|
| Nordic walking Experimental | Experimental | Experimental: Nordic walking Training The total period of training was composed by 9-week of walking with poles, two sessions per week. The cycles were divided into four microcycles composed of three training sessions. Each training session took 60 min. Nordic walking aerobics training was used during the training period. These exercises were performed alternating volume and intensity. The training session was divided into three stages: (a) stretching, joint mobility, and heating; (b) main part (NW); (c) return to the calm and ultimate stretching. Receives: Other: Nordic Walking; Other: Free Walking |
| Free walking | Active comparator | Free walking Training The total period of training was composed by 9-week of walking without poles, two sessions per week. The cycles were divided into four microcycles composed of three training sessions. Each training session took 60 min. Free walking aerobics training was used during the training period. These exercises were performed alternating volume and intensity. The training session was divided into three stages: (a) stretching, joint mobility, and heating; (b) main part (FW); (c) return to the calm and ultimate stretching. Receives: Other: Nordic Walking; Other: Free Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test Timed Up and Go
This teste evaluate the mobility functional in three meters of self-selected speed (TUGSS) or at forced speed (TUGFS)
Measured: Change from baseline at 9 weeks
Secondary outcomes (6)
Locomotor Rehabilitation Index
The Locomotor Rehabilitation Index is a method of determining how close is the SSW compared to the Optimum Speed (Vopt).
Measured: Change from baseline at 9 weeks
Self-selected walking speed - SSWS
This outcome will be measure in test of walking treadmill
Measured: Change from baseline at 9 weeks
Optimal Walking Speed (OPT)
This outcome will be measure through of the registered image movement analysis using the three-dimensional motion analysis system (VICON) of the walking test on treadmill.
Measured: Change from baseline at 9 weeks
Quality of life (QoL)
The quality of life will be estimated using the World Health Organization Quality of Life. (WHOQOL-short domains: physical, psychological, social relationships, environment, and general quality of life) and (WHOQOL-Long domains: sensory abilities, autonomy, Past. Present and Future Activities, social participation, death and dying, intimacy, and general quality of life).
Measured: Change from baseline at 9 weeks
Cognitive function
This outcome will be measure for Montreal Cognitive Assessment (MoCA).
Measured: Change from baseline at 9 weeks
Depressive symptoms
This outcome will be measure for the Geriatric Depression Scale - 15 item. The scale consists of 15 dichotomous questions in which participants are asked to answer yes or no in reference to how they felt over the past week (for instance, "Do you feel that your life is empty?," Do you feel that your situation is hopeless?). Scores range from 0 to 15 with higher scores indicating more depressive symptoms.
Measured: Change from baseline at 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start20 Mar 2013
- Primary completion30 Jun 2013
- Study completion30 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Model description
- Experimental: Nordic walking Experimental: Nordic walking Training The total period of training was composed by 9-week of walking with poles, two sessions per week. The cycles were divided into four microcycles composed of three training sessions. Each training session took 60 min. Nordic walking aerobics training was used during the training period. These exercises were performed alternating volume and intensity. The training session was divided into three stages: (a) stretching, joint mobility, and heating; (b) main part (FW or NW); (c) return to the calm and ultimate stretching. The participants were trained with individualized prescription according to their maximum distance. A heart rate monitor, Model FT4 attached to the chest of the xiphoid process, was used to control the progression of intensity for the training cycles ranging from 60% to 80% of heart rate reserve. Additionally, we used the Borg RPE for training intensity control, which ranged between 13 and 17 of that scale.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Health Science of Porto Alegre, Hospital de Clinicas de Porto Alegre
- Responsible party
- Principal investigator, Leonardo A. Peyré-Tartaruga, Federal University of Rio Grande do Sul
- Investigators
- Leonardo A Peyré-Tartaruga, PhD, Study director, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355521
- Sponsor's protocol ID
- emonteiro
- Acronym
- Walking
- Status last verified
- Nov 2017
- First submitted
- 10 Nov 2017
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26833853
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nordic Walking Training on Functional, Clinical and Biomechanics Parameters in Parkinson's Disease: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03355521
- Acronym / sponsor ID
- Walking / emonteiro
- Conditions
- Parkinson Disease, Parkinson Disease 10
- Keywords
- functionality, gait, kinematics, electromyographic activity, depressive symptoms, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Collaborators
- Federal University of Health Science of Porto Alegre, Hospital de Clinicas de Porto Alegre
- Study start
- 20 Mar 2013 (actual)
- Primary completion
- 30 Jun 2013 (actual)
- Study completion
- 30 Jul 2014 (actual)
- First posted
- 28 Nov 2017 (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 aim of this study was to evaluate and compare the effects of a Nordic and free walking training program on clinical, functional and biomechanical parameters of gait, in people with PD.
Outcomes: Motor symptoms: Staging and severity of PD, balance, walking functional mobility, self-selected walking velocity, and rehabilitation index. Non-Motor symptoms: Cognitive function, depressive symptoms, and quality of life (QL). Outcomes Biomechanics: Kinematic parameters (spatiotemporal and dynamic stability of walking) and neuromuscular parameters (amplitude of the electromyography signal, initial and final activation threshold, activation time and co-contraction index, of the following muscles: Vastus Lateralis (VL), Biceps Femoris (BF), Tibialis Anterior (TA), Gastrocnemius Medialis (GM).
Detailed description
Introduction: Changes in clinical, functional and biomechanical parameters of gait are remarkable features in Parkinson's disease (PD). Such changes are disabling for the performance of daily living activities (DLAs) as they represent a high risk of falls and impair quality of life (QL) in this population. Although exercise is recommended as an effective model of therapeutic intervention, to minimize the symptoms of this disease, little is known about the effects of Nordic walking on motor and non-motor symptoms in patients with PD. Purpose: The aim of this study was to evaluate and compare the effects of a Nordic and free walking training program on clinical, functional and biomechanical parameters of gait, in people with PD. Experimental Design: Randomized controlled clinical trial (RCT). Study Site: Physical Education School of the Federal University of Rio Grande do Sul and the Clinical Hospital of Porto Alegre, in Porto Alegre, Rio Grande do Sul, Brazil. Methods: The sample comprised 33 participants, aged above 50 years, of both sexes, with a clinical diagnosis of idiopathic PD, with the staging of 1-4 in the Hoehn and Yahr scale (H\&Y). The participants received two types of intervention: Nordic walking training program (NW, n = 16) and free walking training program (FW, n = 17), during six weeks. Aiming to evaluate the effects of the training program, the participants underwent the tests in the following period: pre-training + pre-familiarization (T1); post-familiarization + pre-training (T2); post-training (T3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental: Nordic walking Experimental: Nordic walking Training The total period of training was composed by 9-week of walking with poles, two sessions per week. The cycles were divided into four microcycles composed of three training sessions. Each training session took 60 min. Nordic walking aerobics training was used during the training period. These exercises were performed alternating volume and intensity. The training session was divided into three stages: (a) stretching, joint mobility, and heating; (b) main part (FW or NW); (c) return to the calm and ultimate stretching. The participants were trained with individualized prescription according to their maximum distance. A heart rate monitor, Model FT4 attached to the chest of the xiphoid process, was used to control the progression of intensity for the training cycles ranging from 60% to 80% of heart rate reserve. Additionally, we used the Borg RPE for training intensity control, which ranged between 13 and 17 of that scale.
| Arm | Type | Receives |
|---|---|---|
| Nordic walking Experimental | Experimental | Other: Nordic Walking, Other: Free WalkingExperimental: Nordic walking Training The total period of training was composed by 9-week of walking with poles, two sessions per week. The cycles were divided into four microcycles composed of three training sessions. Each training session took 60 min. Nordic walking aerobics training was used during the training period. These exercises were performed alternating volume and intensity. The training session was divided into three stages: (a) stretching, joint mobility, and heating; (b) main part (NW); (c) return to the calm and ultimate stretching. |
| Free walking | Active comparator | Other: Nordic Walking, Other: Free WalkingFree walking Training The total period of training was composed by 9-week of walking without poles, two sessions per week. The cycles were divided into four microcycles composed of three training sessions. Each training session took 60 min. Free walking aerobics training was used during the training period. These exercises were performed alternating volume and intensity. The training session was divided into three stages: (a) stretching, joint mobility, and heating; (b) main part (FW); (c) return to the calm and ultimate stretching. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Show chronic pain or presence of a migraine or nausea in daily life;
- History of labyrinthitis;
- Deep Brain Stimulation (DBS);
- The frequency of training below of 75%.
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 |
|---|---|---|
| Nordic WalkingNordic walking Training the total period of training was composed by 9-week of walking with poles, two sessions per week. The cycles were divided into four microcycles composed of three training sessions. Each training session took 60 min. Free walking aerobics training was used during the training period. These exercises were performed alternating volume and intensity. The training session was divided into three stages: (a) stretching, joint mobility, and heating; (b) main part (FW); (c) return to the calm and ultimate stretching. | Other | Free walking, Nordic walking Experimental |
| Free WalkingFree walking Training The total period of training was composed by 9-week of walking without poles, two sessions per week. The cycles were divided into four microcycles composed of three training sessions. Each training session took 60 min. Free walking aerobics training was used during the training period. These exercises were performed alternating volume and intensity. The training session was divided into three stages: (a) stretching, joint mobility, and heating; (b) main part (FW); (c) return to the calm and ultimate stretching. | Other | Free walking, Nordic walking Experimental |
Primary outcome
Test Timed Up and Go
Time frame: Change from baseline at 9 weeks
This teste evaluate the mobility functional in three meters of self-selected speed (TUGSS) or at forced speed (TUGFS)
6 secondary outcomes
Locomotor Rehabilitation Index
Time frame: Change from baseline at 9 weeks
Self-selected walking speed - SSWS
Time frame: Change from baseline at 9 weeks
Optimal Walking Speed (OPT)
Time frame: Change from baseline at 9 weeks
Quality of life (QoL)
Time frame: Change from baseline at 9 weeks
Cognitive function
Time frame: Change from baseline at 9 weeks
Depressive symptoms
Time frame: Change from baseline at 9 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 28 Nov 2017.
- Results publication: PubMed 26833853Monteiro 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.
- Effects of Nordic walking training on functional parameters in Parkinson's disease: a randomized controlled clinical trialLink provided by the sponsor.
- 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.
Leonardo A Peyré-Tartaruga, PhD study director
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nordic Walking and Free Walking in people with Parkinson Disease and Parkinson Disease 10, run by Federal University of Rio Grande do Sul 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 0 inclusion and 4 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 28 Nov 2017. 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 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?
Test Timed Up and Go (time frame: Change from baseline at 9 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 NCT03355521, which also lists 1 linked publication.
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 28 Nov 2017.