Parkinson DiseaseWe-Walk-PDNCT06707402
The Effects of 24-Weeks Community-based Brisk Walking in People With Parkinson's Disease
A study testing WALK, ACTIVE and CON in people with Parkinson Disease, run by University of Aarhus at 1 site in Denmark.
Trial summary
The goal of this clinical trial is to investigate if brisk walking can improve walking function in people with Parkinson's disease and what kind of brisk walking intervention that is most effective. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- WALK, ACTIVE and CON
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Mar 2025to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinically diagnosed with Parkinson's disease
- aged ≥40 years
- Hoehn and Yahr stage ≤3
- able to independently undertake transportation back and forth from test days and training sessions
- expectedly able to complete ≥85% of the training sessions
- experience walking difficulties (the generic walking scale (Walk-12G) score ≥8.5).
Who cannot join
- have another neurological disorder or other disorders that affect gait and balance (e.g., severe arthritis or arthrosis)
- are pregnant
- have dementia (Montreal Cognitive Assessment score \<18)
- are suffering from alcohol abuse (i.e., exceeding ten units per week, according to the Danish Health Authority recommendation
- have cardiovascular, respiratory, orthopedic, or metabolic disorders or other medical comorbidities hindering participation in maximal exercise testing.
- have a depression
- use an activity tracker during exercise
- performing high-intensity brisk walking three or more times during a week.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ulrik Dalgas, Professor contact
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University, Department of Public Health, Sport Science
Aarhus C, 8000
Frederik B Jensen, MSc, +4521268252, fbj@ph.au.dk
About this study
Official title: The Effects of 24 Weeks Community-based Brisk Walking on Physical Function, Comorbidities, Cognition, Disease Severity, and Health-related Quality of Life in People With Parkinson's Disease.
The goal of this clinical trial is to investigate if brisk walking can improve walking function in people with Parkinson's disease and what kind of brisk walking intervention that is most effective. The main questions are:
If brisk walking can reduce self-perceived walking difficulty What type of exercise intervention is most effective. Researchers will compare a brisk walking group receiving a personalized walking program with a group receiving an activity tracker and a control group.
Read more
Participants will
- be tested at baseline (0 weeks), post the intervention period (24 weeks) and after a follow-up period (48 weeks).
- be randomly allocated to one of three groups at baseline.
- follow the prescribed intervention they are allocated to.
Read the detailed description
Background Parkinson's disease is a progressive neurodegenerative disorder and one of the leading causes of disability worldwide. Impaired walking is considered one of the most bothersome symptoms that people with Parkinson's disease wish to improve, affecting independence, ability to work, and quality of life. Walking impairment is present from the early stage of the disease with an expected progression and a more frequent presentation along the course of the disease. Currently, only few medical treatments exist that target walking, and these show minor effects while causing side effects. Non-pharmacological interventions that can improve or prevent loss of walking ability are therefore highly warranted.
Exercise is a promising non-pharmacological intervention in people with Parkinson's disease with studies reporting improved walking performance following different exercise modalities, including high-intensity aerobic exercise. Despite extensive research investigating the effects of various exercise interventions on walking, few have examined more traditional walking training. This is somewhat surprising as walking is task-specific training for walking itself, while also being feasible and showing promising results in people with Parkinson's disease. In addition, walking is easily accessible and a potential efficient low-cost intervention that is commonly used and therefore well-known in clinical rehabilitation practice. Yet only two long-term studies could be located applying walking training. Despite being long-term, these studies are limited by 1) not considering possible factors facilitating adherence, 2) not performing follow-up testing, 3) not applying any inclusion criterion for walking impairment implying that any potential effects might be diminished due to well-functioning participants without walking impairments, 4) not including a comprehensive test battery (i.e., no registration of comorbidities, physical activity level, health-related quality of life), and 5) not investigating the effect on perceived walking difficulties despite the relevance of understanding the subjective impact of walking training. Further evaluation of walking interventions is therefore needed in people with Parkinson's disease.
Despite the importance of a physically active lifestyle, only 27% (potentially less) of people with Parkinson's disease meet the established physical activity recommendations (≥ 150 min/week of moderate to vigorous physical activity). Therefore, it is very challenging to design a walking intervention that increases physical activity levels while being sustainable. To do so, it is essential to incorporate motivational factors that facilitate adherence. These include high self-efficacy, low cost, less travel, self-perceived positive effects of walking, and support from family/carers and health professionals. To comply with these factors, remotely or partly supervised home-based exercise has been suggested as a feasible and effective strategy to alleviate Parkinson's disease motor symptoms. Another aspect to consider is group vs. individually based exercise sessions. Both have shown equally effective in improving functional capacity in healthy individuals, but combined group- and individual-based exercise has been recommended as the most attractive model for the broadest range of people with Parkinson's disease. Overall, by incorporating these strategies in walking training, this exercise modality might offer a sustainable, cost-effective, and easy-to-apply intervention that can be offered in local communities worldwide. This would also include people with Parkinson's disease living without easy access to training facilities or who are governed by poor healthcare systems. Another even more easy-to-apply and low-cost intervention to increase physical activity, is to offer a wearable activity tracker. One study reported increased physical activity level in people with Multiple sclerosis when offering a wearable activity tracker and engaging in group- and individual motivational online meetings compared to a control group. However, to the investigator's knowledge, this has not been assessed in people with Parkinson's disease.
Therefore, the primary aim is to investigate the efficacy of a 24-week combined supervised group- and non-supervised individual-based walking intervention (WALK) compared to both a group receiving a wearable activity tracker (HOME) and a control group (CON) on perceived walking difficulties in people with Parkinson's disease. The secondary aims are to identify and characterize responders and non-responders to walking training and to investigate the cost-effectiveness of these exercise interventions.
The hypothesis is that the WALK group will be superior to HOME and CON, while HOME will be superior to CON after 24 weeks in reducing perceived walking difficulties, which will be sustained after a 24-week follow up.
Methods and materials The project includes one main study and two embedded studies. Study 1 (main study): A single-blinded randomized controlled trial including three interventions (WALK, HOME and CON). Tests will be conducted at 0, 24 and 48 weeks.
Study 2: Identification and characterization of responders (i.e., ≥3 point decrease in the generic walking scale or ≥6% increase in maximal oxygen consumption) and non-responders to walking training.
Study 3: Economic evaluation of WALK compared to HOME and CON.
Statistical considerations The study sample size is powered based on descriptive Parkinson's disease data on the primary outcome (i.e., generic walking scale) and the assumption that a clinically meaningful change of ≥3 points will be detected between all three groups after 24 weeks (i.e. WALK > HOME > CON). Moreover, based on the inclusion criteria, a more homogeneous population sample compared to the previous study is expected, and thus a lower standard deviation. Lastly, it is expected that 15% will drop out. A one-way ANOVA was used to estimate the sample size (a=0.05, power=0.8, 24-weeks post mean values for CON, HOME and WALK = 15, 12, 9 ± 8, and dropout proportion = 15%). The calculation showed that 43 people with Parkinson's disease should be enrolled into each group.
- Conditions
- Parkinson Disease
- Being tested
- WALK, ACTIVE, CON
- Keywords
- Brisk walking, Walking difficulty
- Medical subject headings
- Parkinson Disease, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WALKBehavioural
The intervention covers a personalized 24-week progressive brisk walking program. The program consists of moderate to high-intensity walking (i.e., 55-85% maximal heart rate) performed as both continuous and interval training sessions 2-3 times/week lasting 30-60 min/session. Four individually supervised sessions will be conducted in the first 2 weeks, while 1 supervised group session will be received bi-weekly. Furthermore, the group will receive an activity tracker and monthly telephone calls will be offered to adjust the intensity of the program (if necessary), clarify any questions regarding the intervention, and give verbal motivation. At the baseline assessment and at week 12, during a group training session, the figure of 8 walk test will be conducted to gain insigh tinto the current status of the training program. Lastly, after completion of the baseline test, the participants are given a brief educational session (walking advice) on recommended guidelines for physical activity
ACTIVEBehavioural
Will receive an activity tracker is provided alongside monthly telephone calls and walking advice after the baseline test. Similar to WALK, 3 telephone calls are provided during the follow-up period.
CONBehavioural
Receives a brief educational session (walking advice) is provided at baseline, after which no further contacts are made.
| Study group | Role | What they receive |
|---|---|---|
| Combined individual home-based and supervised group-based walking exercise | Experimental | 43 people with Parkinsons disease would be randomly assigned to this experimental group. The group will receive the intervention "WALK", that covers a personalized exercise program and group exercise session. It further covers the same as in the HOME group. Receives: Behavioral: WALK |
| Individual home-based exercise | Active comparator | 43 people with Parkinsons disease would be randomly assigned to this active comparator group. The group receives the intervention (HOME) that covers an activity tracker and motivational telephone calls. It further covers the same as in the CON group. Receives: Behavioral: ACTIVE |
| Control group | Sham comparator | 43 people with Parkinsons disease would be randomly assigned to this sham comparator group. The group will only receive a short lecture in Parkinsons disease and exercise after completing the baseline test and allocated to the group. Receives: Behavioral: CON |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Generic Walking Scale - 12 items (Walk-12G)
The generic walking scale is a 12-item questionnaire covering different aspects of walking difficulties during everyday life. Scores ranged from 0 (no problem) to 42 (severe walking difficulties)
Measured: From enrollment to the end of follow-up at 48 weeks
Secondary outcomes (24)
Demographic measures
Demographic measures cover the following:
Sex (male/female) Age (years) Weight (kg) Height (cm) Body mass index (kg/m2) Fat mass (%) Muscle mass (kg) Time of diagnosis (years) Blood pressure (mmHg) Years of education (years) Levodopa Equivalent Daily Dose (Parkinson's disease medication) Beta blocker (yes/no)
Measured: From enrollment to the end of follow-up at 48 weeks
Chair rise
Linear encoder equipment is used to measure muscle force and muscle power during a chair rise.
Measured: From enrollment to the end of follow-up at 48 weeks
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating scale (MDS-UPDRS) part I, II, III, and IV
All four parts (I to IV) are collected during the study as well as the individual motor symptoms from part III (rigidity, bradykinesia, postural instability and tremor) Part I assesses non-motor symptoms experience of daily life. Score ranged from 0 (no problem) to 52 (severe problems) Part II assesses motor symptoms experienced of daily life. Score ranged from 0 (no problem) to 52 (severe problems) Part III is a motor examination. Scores ranged from 0 (no problem) to 132 (severe problems) Part IV assesses motor complications. Scores ranged from 0 (no problem) to 24 (severe problems) Rigidity covers items 3.3 and scores from 0 (no problem) to 20 (severe problems). Bradykinesia covers items 3.4-3.8 and 3.14 and scores from 0 (no problem) to 44 (severe problems) postural instability covers items 3.9-3.13 and scores from 0 (no problem) to 20 (severe problems). Tremor covers items 3.15-3.18 and scores from 0 (no problem) to 40 (severe problems).
Measured: From enrollment to the end of follow-up at 48 weeks
Mini Balance Evaluation Systems Test (MiniBESTest)
Assess balance. Scores from 0 (worse) to 28 (best) points
Measured: From enrollment to the end of follow-up at 48 weeks
Timed-up and Go (TUG)
Three trials are performed. The fastest trial is used for analysis.
Measured: From enrollment to the end of follow-up at 48 weeks
Six-Spot Step Test (SSST)
Four trials are performed (two for right leg and two for left leg). The average time for the four trials are used in the analysis
Measured: From enrollment to the end of follow-up at 48 weeks
Six-minute walk test (6MWT)
Total distance (m) covered during 6 minutes of fast walking
Measured: From enrollment to the end of follow-up at 48 weeks
The Montreal Cognitive Assessment (MoCA) test
Scores from 0 (worse) to 30 (best). Total score are used in the analysis
Measured: From enrollment to the end of follow-up at 48 weeks
Symbol Digit Modalities Test (SDMT)
Measures cognition. Test duration is 90 sec. Score of 0 is worse, and the higher the better. There is no limit but often not more than 75 points.
Measured: From enrollment to the end of follow-up at 48 weeks
Maximal oxygen consumption test (VO2max test)
Maximal oxygen consumption test (VO2max) would be performed on a ergometer bicycle. VO2max (O2 ml/min) will be measured. Weight would be used to calculate weight normalized VO2max (O2 ml/kg/min)
Measured: From enrollment to the end of follow-up at 48 weeks
Borg scale (part of VO2max test)
The Borg scale assesses self-perceived exertion. It ranges from 6 (minor exertion) to 20 (maximum exertion). The scale would be used as part of the VO2max test.
Measured: From enrollment to the end of follow-up at 48 weeks
Maximal heart rate (part of VO2max test)
Maximal heart rate (beats/min) would be obtained as part of the VO2max test. The highest measure would be used for further analysis.
Measured: From enrollment to the end of follow-up at 48 weeks
Physcial activity level
Physical activity level will be assessed using accelerometer (Axivity A3) for 7 consecutive days.
Measured: From enrollment to the end of follow-up at 48 weeks
Physical Activity Enjoyment Scale (PACES) (questionnaire)
The short version with 8 items will be used for both interventions groups (WALK and ACTIVE). It assesses the enjoyment of performing physical activity and scores ranged from 0 (no enjoyment) to 56 (greatest level of enjoyment)
Measured: Only at the post test (24 weeks)
Baecke Physical Activity Questionnaire (BHPAQ) (questionnaire)
Assess physical activity during work and leisure time and amount of sport participation. Scores ranged from 1 (low activity) to 5 (a lot of activity) in the three categories.
Measured: From enrollment to the end of follow-up at 48 weeks
EuroQol-5 Domain-5 level (EQ-5D-5L) (questionnaire)
Assess quality of life. Scores in Denmark ranged from -0.757 (worse quality of life) to 1.0 (best quality of life).
Measured: From enrollment to the end of follow-up at 48 weeks
Modfied Fatigue Impact Scale (MFIS) (questionnaire)
The questionnaire are included to be used in future cross-sectional analyses. It assesses fatigue and scores ranged from 0 (not fatigue) to 84 (extremely fatigued). The questionnaire is also subdivided into physical (0-36 points) cognitive (0-40 points) and psychosocial (0-8 points) subscales.
Measured: Baseline only
Major Depression Inventory (MDI) (questionnaire)
It assesses depression symptoms. Scores ranged from 0 (no depression) to 50 (severe depression)
Measured: From enrollment to the end of follow-up at 48 weeks
Non-Motor Symptoms Questionnaire (NMSQuest) (questionnaire)
Assess non-motor symptoms and contains 30 items. It scores from 0 (no symptoms) to 30 (severe symptoms)
Measured: From enrollment to the end of follow-up at 48 weeks
Parkinsons Disease Questionnaire-39 items (PDQ-39) (questionnaire)
Assess quality of life. It is specific for Parkinsons disease. It contains several domains. The total score ranged from 0 (no problem) to 100 (severe problems).
Measured: From enrollment to the end of follow-up at 48 weeks
Parkinsons disease Fatigue Scale-16 items (PFS-16) (questionnaire)
Parkinson specific survey that assesses fatigue. Score ranged from 16 (no fatigue) and 80 (severe fatigue)
Measured: From enrollment to the end of follow-up at 48 weeks
The Pittsburgh Sleep Quality Index (PSQI) (questionnaire)
Assess sleep quality. Contains 10 items (and some additional items). Score ranged from 0 (no problem) to 21 (severe problem)
Measured: From enrollment to the end of follow-up at 48 weeks
Breif Pain Inventory (BPI) (questionnaire)
Assess pain and interference. It contains 16 items, and the score is divided in pain which goes from 0 (no pain) to 40 (worst pain) and interference of pain which goes from 0 (no interference) to 70 (extreme interference).
Measured: From enrollment to the end of follow-up at 48 weeks
Falls Efficacy Scale - International (FES-I) (questionnaire)
Assess fear of falling. Contains 16 items. Score ranged from 16 (no fear) to 64 (severe fear)
Measured: From enrollment to the end of follow-up at 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start11 Mar 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Viborg Regional Hospital, Danish Parkinson Association, Fonden af 2. Juli 1984 til bekæmpelse af Parkinsons Sygdom, Denmark
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707402
- Sponsor's protocol ID
- Walking and PD
- Acronym
- We-Walk-PD
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to make the individual data available for other researchers. This requires informed consents from each participant and a data processing agreement, according to the GDPR rules, which have not been prepared prior to the initiation of the study. However, a co-supervisor (Erika Franzén, Sweden) affiliated to the project might receive some relevant pseudonymized data. If that is the case, the protocol description will be updated.
Publications
Lindh-Rengifo M, Jonasson SB, Ullen S, Mattsson-Carlgren N, Nilsson MH. Perceived walking difficulties in Parkinson's disease - predictors and changes over time. BMC Geriatr. 2021 Apr 1;21(1):221. doi: 10.1186/s12877-021-02113-0.
PubMed 33794786Frost R, Levati S, McClurg D, Brady M, Williams B. What Adherence Measures Should Be Used in Trials of Home-Based Rehabilitation Interventions? A Systematic Review of the Validity, Reliability, and Acceptability of Measures. Arch Phys Med Rehabil. 2017 Jun;98(6):1241-1256.e45. doi: 10.1016/j.apmr.2016.08.482. Epub 2016 Oct 1.
PubMed 27702555Rudmik L, Drummond M. Health economic evaluation: important principles and methodology. Laryngoscope. 2013 Jun;123(6):1341-7. doi: 10.1002/lary.23943. Epub 2013 Mar 11.
PubMed 23483522Chaudhuri KR, Martinez-Martin P, Brown RG, Sethi K, Stocchi F, Odin P, Ondo W, Abe K, Macphee G, Macmahon D, Barone P, Rabey M, Forbes A, Breen K, Tluk S, Naidu Y, Olanow W, Williams AJ, Thomas S, Rye D, Tsuboi Y, Hand A, Schapira AH. The metric properties of a novel non-motor symptoms scale for Parkinson's disease: Results from an international pilot study. Mov Disord. 2007 Oct 15;22(13):1901-11. doi: 10.1002/mds.21596.
PubMed 17674410Baecke JA, Burema J, Frijters JE. A short questionnaire for the measurement of habitual physical activity in epidemiological studies. Am J Clin Nutr. 1982 Nov;36(5):936-42. doi: 10.1093/ajcn/36.5.936.
PubMed 7137077Schrag A, Selai C, Jahanshahi M, Quinn NP. The EQ-5D--a generic quality of life measure-is a useful instrument to measure quality of life in patients with Parkinson's disease. J Neurol Neurosurg Psychiatry. 2000 Jul;69(1):67-73. doi: 10.1136/jnnp.69.1.67.
PubMed 10864606Peto V, Jenkinson C, Fitzpatrick R. PDQ-39: a review of the development, validation and application of a Parkinson's disease quality of life questionnaire and its associated measures. J Neurol. 1998 May;245 Suppl 1:S10-4. doi: 10.1007/pl00007730.
PubMed 9617716Pascoe M, Alamri Y, Dalrymple-Alford J, Anderson T, MacAskill M. The Symbol-Digit Modalities Test in Mild Cognitive Impairment: Evidence from Parkinson's Disease Patients. Eur Neurol. 2018;79(3-4):206-210. doi: 10.1159/000485669. Epub 2018 Mar 29.
PubMed 29597229Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.
PubMed 19025984Clarke CL, Taylor J, Crighton LJ, Goodbrand JA, McMurdo MET, Witham MD. Validation of the AX3 triaxial accelerometer in older functionally impaired people. Aging Clin Exp Res. 2017 Jun;29(3):451-457. doi: 10.1007/s40520-016-0604-8. Epub 2016 Jul 19.
PubMed 27435918Bonde-Jensen F, Dalgas U, Hvid LG, Langeskov-Christensen M. Validity and reliability of linear encoder muscle power testing in persons with Parkinson's disease. Clin Rehabil. 2024 May;38(5):678-687. doi: 10.1177/02692155231224987. Epub 2024 Jan 9.
PubMed 38193269Brincks J, Callesen J, Johnsen E, Dalgas U. A study of the validity of the Six-Spot Step Test in ambulatory people with Parkinson's disease. Clin Rehabil. 2019 Jul;33(7):1206-1213. doi: 10.1177/0269215519833016. Epub 2019 Feb 25.
PubMed 30798635Brincks J, Callesen J, Dalgas U, Johnsen E. Test-retest reliability and limits of agreement of the Six-Spot Step Test in people with Parkinson's disease. Clin Rehabil. 2019 Feb;33(2):285-292. doi: 10.1177/0269215518803144.
PubMed 30789075Morris S, Morris ME, Iansek R. Reliability of measurements obtained with the Timed "Up & Go" test in people with Parkinson disease. Phys Ther. 2001 Feb;81(2):810-8. doi: 10.1093/ptj/81.2.810.
PubMed 11175678American Thoracic Society; European Respiratory Society. American Thoracic Society/European Respiratory Society International Multidisciplinary Consensus Classification of the Idiopathic Interstitial Pneumonias. This joint statement of the American Thoracic Society (ATS), and the European Respiratory Society (ERS) was adopted by the ATS board of directors, June 2001 and by the ERS Executive Committee, June 2001. Am J Respir Crit Care Med. 2002 Jan 15;165(2):277-304. doi: 10.1164/ajrccm.165.2.ats01. No abstract available.
PubMed 11790668
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of 24 Weeks Community-based Brisk Walking on Physical Function, Comorbidities, Cognition, Disease Severity, and Health-related Quality of Life in People With Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT06707402
- Acronym / sponsor ID
- We-Walk-PD / Walking and PD
- Conditions
- Parkinson Disease
- Keywords
- Brisk walking, Walking difficulty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Viborg Regional Hospital, Danish Parkinson Association, Fonden af 2. Juli 1984 til bekæmpelse af Parkinsons Sygdom, Denmark
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 27 Nov 2024 (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 goal of this clinical trial is to investigate if brisk walking can improve walking function in people with Parkinson's disease and what kind of brisk walking intervention that is most effective. The main questions are:
If brisk walking can reduce self-perceived walking difficulty What type of exercise intervention is most effective. Researchers will compare a brisk walking group receiving a personalized walking program with a group receiving an activity tracker and a control group.
Participants will
- be tested at baseline (0 weeks), post the intervention period (24 weeks) and after a follow-up period (48 weeks).
- be randomly allocated to one of three groups at baseline.
- follow the prescribed intervention they are allocated to.
Detailed description
Background Parkinson's disease is a progressive neurodegenerative disorder and one of the leading causes of disability worldwide. Impaired walking is considered one of the most bothersome symptoms that people with Parkinson's disease wish to improve, affecting independence, ability to work, and quality of life. Walking impairment is present from the early stage of the disease with an expected progression and a more frequent presentation along the course of the disease. Currently, only few medical treatments exist that target walking, and these show minor effects while causing side effects. Non-pharmacological interventions that can improve or prevent loss of walking ability are therefore highly warranted.
Exercise is a promising non-pharmacological intervention in people with Parkinson's disease with studies reporting improved walking performance following different exercise modalities, including high-intensity aerobic exercise. Despite extensive research investigating the effects of various exercise interventions on walking, few have examined more traditional walking training. This is somewhat surprising as walking is task-specific training for walking itself, while also being feasible and showing promising results in people with Parkinson's disease. In addition, walking is easily accessible and a potential efficient low-cost intervention that is commonly used and therefore well-known in clinical rehabilitation practice. Yet only two long-term studies could be located applying walking training. Despite being long-term, these studies are limited by 1) not considering possible factors facilitating adherence, 2) not performing follow-up testing, 3) not applying any inclusion criterion for walking impairment implying that any potential effects might be diminished due to well-functioning participants without walking impairments, 4) not including a comprehensive test battery (i.e., no registration of comorbidities, physical activity level, health-related quality of life), and 5) not investigating the effect on perceived walking difficulties despite the relevance of understanding the subjective impact of walking training. Further evaluation of walking interventions is therefore needed in people with Parkinson's disease.
Despite the importance of a physically active lifestyle, only 27% (potentially less) of people with Parkinson's disease meet the established physical activity recommendations (≥ 150 min/week of moderate to vigorous physical activity). Therefore, it is very challenging to design a walking intervention that increases physical activity levels while being sustainable. To do so, it is essential to incorporate motivational factors that facilitate adherence. These include high self-efficacy, low cost, less travel, self-perceived positive effects of walking, and support from family/carers and health professionals. To comply with these factors, remotely or partly supervised home-based exercise has been suggested as a feasible and effective strategy to alleviate Parkinson's disease motor symptoms. Another aspect to consider is group vs. individually based exercise sessions. Both have shown equally effective in improving functional capacity in healthy individuals, but combined group- and individual-based exercise has been recommended as the most attractive model for the broadest range of people with Parkinson's disease. Overall, by incorporating these strategies in walking training, this exercise modality might offer a sustainable, cost-effective, and easy-to-apply intervention that can be offered in local communities worldwide. This would also include people with Parkinson's disease living without easy access to training facilities or who are governed by poor healthcare systems. Another even more easy-to-apply and low-cost intervention to increase physical activity, is to offer a wearable activity tracker. One study reported increased physical activity level in people with Multiple sclerosis when offering a wearable activity tracker and engaging in group- and individual motivational online meetings compared to a control group. However, to the investigator's knowledge, this has not been assessed in people with Parkinson's disease.
Therefore, the primary aim is to investigate the efficacy of a 24-week combined supervised group- and non-supervised individual-based walking intervention (WALK) compared to both a group receiving a wearable activity tracker (HOME) and a control group (CON) on perceived walking difficulties in people with Parkinson's disease. The secondary aims are to identify and characterize responders and non-responders to walking training and to investigate the cost-effectiveness of these exercise interventions.
The hypothesis is that the WALK group will be superior to HOME and CON, while HOME will be superior to CON after 24 weeks in reducing perceived walking difficulties, which will be sustained after a 24-week follow up.
Methods and materials The project includes one main study and two embedded studies. Study 1 (main study): A single-blinded randomized controlled trial including three interventions (WALK, HOME and CON). Tests will be conducted at 0, 24 and 48 weeks.
Study 2: Identification and characterization of responders (i.e., ≥3 point decrease in the generic walking scale or ≥6% increase in maximal oxygen consumption) and non-responders to walking training.
Study 3: Economic evaluation of WALK compared to HOME and CON.
Statistical considerations The study sample size is powered based on descriptive Parkinson's disease data on the primary outcome (i.e., generic walking scale) and the assumption that a clinically meaningful change of ≥3 points will be detected between all three groups after 24 weeks (i.e. WALK > HOME > CON). Moreover, based on the inclusion criteria, a more homogeneous population sample compared to the previous study is expected, and thus a lower standard deviation. Lastly, it is expected that 15% will drop out. A one-way ANOVA was used to estimate the sample size (a=0.05, power=0.8, 24-weeks post mean values for CON, HOME and WALK = 15, 12, 9 ± 8, and dropout proportion = 15%). The calculation showed that 43 people with Parkinson's disease should be enrolled into each group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combined individual home-based and supervised group-based walking exercise | Experimental | Behavioral: WALK43 people with Parkinsons disease would be randomly assigned to this experimental group. The group will receive the intervention "WALK", that covers a personalized exercise program and group exercise session. It further covers the same as in the HOME group. |
| Individual home-based exercise | Active comparator | Behavioral: ACTIVE43 people with Parkinsons disease would be randomly assigned to this active comparator group. The group receives the intervention (HOME) that covers an activity tracker and motivational telephone calls. It further covers the same as in the CON group. |
| Control group | Sham comparator | Behavioral: CON43 people with Parkinsons disease would be randomly assigned to this sham comparator group. The group will only receive a short lecture in Parkinsons disease and exercise after completing the baseline test and allocated to the group. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- clinically diagnosed with Parkinson's disease
- aged ≥40 years
- Hoehn and Yahr stage ≤3
- able to independently undertake transportation back and forth from test days and training sessions
- expectedly able to complete ≥85% of the training sessions
Key exclusion criteria (8 listed)
- have another neurological disorder or other disorders that affect gait and balance (e.g., severe arthritis or arthrosis)
- are pregnant
- have dementia (Montreal Cognitive Assessment score \<18)
- are suffering from alcohol abuse (i.e., exceeding ten units per week, according to the Danish Health Authority recommendation
- have cardiovascular, respiratory, orthopedic, or metabolic disorders or other medical comorbidities hindering participation in maximal exercise testing.
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 |
|---|---|---|
| WALKThe intervention covers a personalized 24-week progressive brisk walking program. The program consists of moderate to high-intensity walking (i.e., 55-85% maximal heart rate) performed as both continuous and interval training sessions 2-3 times/week lasting 30-60 min/session. Four individually supervised sessions will be conducted in the first 2 weeks, while 1 supervised group session will be received bi-weekly. Furthermore, the group will receive an activity tracker and monthly telephone calls will be offered to adjust the intensity of the program (if necessary), clarify any questions regarding the intervention, and give verbal motivation. At the baseline assessment and at week 12, during a group training session, the figure of 8 walk test will be conducted to gain insigh tinto the current status of the training program. Lastly, after completion of the baseline test, the participants are given a brief educational session (walking advice) on recommended guidelines for physical activity | Behavioural | Combined individual home-based and supervised group-based walking exercise |
| ACTIVEWill receive an activity tracker is provided alongside monthly telephone calls and walking advice after the baseline test. Similar to WALK, 3 telephone calls are provided during the follow-up period. | Behavioural | Individual home-based exercise |
| CONReceives a brief educational session (walking advice) is provided at baseline, after which no further contacts are made. | Behavioural | Control group |
Primary outcome
The Generic Walking Scale - 12 items (Walk-12G)
Time frame: From enrollment to the end of follow-up at 48 weeks
The generic walking scale is a 12-item questionnaire covering different aspects of walking difficulties during everyday life. Scores ranged from 0 (no problem) to 42 (severe walking difficulties)
24 secondary outcomes
Demographic measures
Time frame: From enrollment to the end of follow-up at 48 weeks
Chair rise
Time frame: From enrollment to the end of follow-up at 48 weeks
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating scale (MDS-UPDRS) part I, II, III, and IV
Time frame: From enrollment to the end of follow-up at 48 weeks
Mini Balance Evaluation Systems Test (MiniBESTest)
Time frame: From enrollment to the end of follow-up at 48 weeks
Timed-up and Go (TUG)
Time frame: From enrollment to the end of follow-up at 48 weeks
Six-Spot Step Test (SSST)
Time frame: From enrollment to the end of follow-up at 48 weeks
Six-minute walk test (6MWT)
Time frame: From enrollment to the end of follow-up at 48 weeks
The Montreal Cognitive Assessment (MoCA) test
Time frame: From enrollment to the end of follow-up at 48 weeks
Symbol Digit Modalities Test (SDMT)
Time frame: From enrollment to the end of follow-up at 48 weeks
Maximal oxygen consumption test (VO2max test)
Time frame: From enrollment to the end of follow-up at 48 weeks
Borg scale (part of VO2max test)
Time frame: From enrollment to the end of follow-up at 48 weeks
Maximal heart rate (part of VO2max test)
Time frame: From enrollment to the end of follow-up at 48 weeks
Physcial activity level
Time frame: From enrollment to the end of follow-up at 48 weeks
Physical Activity Enjoyment Scale (PACES) (questionnaire)
Time frame: Only at the post test (24 weeks)
Baecke Physical Activity Questionnaire (BHPAQ) (questionnaire)
Time frame: From enrollment to the end of follow-up at 48 weeks
EuroQol-5 Domain-5 level (EQ-5D-5L) (questionnaire)
Time frame: From enrollment to the end of follow-up at 48 weeks
Modfied Fatigue Impact Scale (MFIS) (questionnaire)
Time frame: Baseline only
Major Depression Inventory (MDI) (questionnaire)
Time frame: From enrollment to the end of follow-up at 48 weeks
Non-Motor Symptoms Questionnaire (NMSQuest) (questionnaire)
Time frame: From enrollment to the end of follow-up at 48 weeks
Parkinsons Disease Questionnaire-39 items (PDQ-39) (questionnaire)
Time frame: From enrollment to the end of follow-up at 48 weeks
Parkinsons disease Fatigue Scale-16 items (PFS-16) (questionnaire)
Time frame: From enrollment to the end of follow-up at 48 weeks
The Pittsburgh Sleep Quality Index (PSQI) (questionnaire)
Time frame: From enrollment to the end of follow-up at 48 weeks
Breif Pain Inventory (BPI) (questionnaire)
Time frame: From enrollment to the end of follow-up at 48 weeks
Falls Efficacy Scale - International (FES-I) (questionnaire)
Time frame: From enrollment to the end of follow-up at 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Background: PubMed 33794786Lindh-Rengifo M, Jonasson SB, Ullen S, Mattsson-Carlgren N, Nilsson MH. Perceived walking difficulties in Parkinson's disease - predictors and changes over time. BMC Geriatr. 2021 Apr 1;21(1):221. doi: 10.1186/s12877-021-02113-0.
- Background: PubMed 27702555Frost R, Levati S, McClurg D, Brady M, Williams B. What Adherence Measures Should Be Used in Trials of Home-Based Rehabilitation Interventions? A Systematic Review of the Validity, Reliability, and Acceptability of Measures. Arch Phys Med Rehabil. 2017 Jun;98(6):1241-1256.e45. doi: 10.1016/j.apmr.2016.08.482. Epub 2016 Oct 1.
- Background: PubMed 23483522Rudmik L, Drummond M. Health economic evaluation: important principles and methodology. Laryngoscope. 2013 Jun;123(6):1341-7. doi: 10.1002/lary.23943. Epub 2013 Mar 11.
- Background: PubMed 17674410Chaudhuri KR, Martinez-Martin P, Brown RG, Sethi K, Stocchi F, Odin P, Ondo W, Abe K, Macphee G, Macmahon D, Barone P, Rabey M, Forbes A, Breen K, Tluk S, Naidu Y, Olanow W, Williams AJ, Thomas S, Rye D, Tsuboi Y, Hand A, Schapira AH. The metric properties of a novel non-motor symptoms scale for Parkinson's disease: Results from an international pilot study. Mov Disord. 2007 Oct 15;22(13):1901-11. doi: 10.1002/mds.21596.
- Background: PubMed 7137077Baecke JA, Burema J, Frijters JE. A short questionnaire for the measurement of habitual physical activity in epidemiological studies. Am J Clin Nutr. 1982 Nov;36(5):936-42. doi: 10.1093/ajcn/36.5.936.
- Background: PubMed 10864606Schrag A, Selai C, Jahanshahi M, Quinn NP. The EQ-5D--a generic quality of life measure-is a useful instrument to measure quality of life in patients with Parkinson's disease. J Neurol Neurosurg Psychiatry. 2000 Jul;69(1):67-73. doi: 10.1136/jnnp.69.1.67.
- Background: PubMed 9617716Peto V, Jenkinson C, Fitzpatrick R. PDQ-39: a review of the development, validation and application of a Parkinson's disease quality of life questionnaire and its associated measures. J Neurol. 1998 May;245 Suppl 1:S10-4. doi: 10.1007/pl00007730.
- Background: PubMed 29597229Pascoe M, Alamri Y, Dalrymple-Alford J, Anderson T, MacAskill M. The Symbol-Digit Modalities Test in Mild Cognitive Impairment: Evidence from Parkinson's Disease Patients. Eur Neurol. 2018;79(3-4):206-210. doi: 10.1159/000485669. Epub 2018 Mar 29.
- Background: PubMed 19025984Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.
- Background: PubMed 27435918Clarke CL, Taylor J, Crighton LJ, Goodbrand JA, McMurdo MET, Witham MD. Validation of the AX3 triaxial accelerometer in older functionally impaired people. Aging Clin Exp Res. 2017 Jun;29(3):451-457. doi: 10.1007/s40520-016-0604-8. Epub 2016 Jul 19.
- Background: PubMed 38193269Bonde-Jensen F, Dalgas U, Hvid LG, Langeskov-Christensen M. Validity and reliability of linear encoder muscle power testing in persons with Parkinson's disease. Clin Rehabil. 2024 May;38(5):678-687. doi: 10.1177/02692155231224987. Epub 2024 Jan 9.
- Background: PubMed 30798635Brincks J, Callesen J, Johnsen E, Dalgas U. A study of the validity of the Six-Spot Step Test in ambulatory people with Parkinson's disease. Clin Rehabil. 2019 Jul;33(7):1206-1213. doi: 10.1177/0269215519833016. Epub 2019 Feb 25.
- Individual participant dataSharing planned: No. There is currently no plan to make the individual data available for other researchers. This requires informed consents from each participant and a data processing agreement, according to the GDPR rules, which have not been prepared prior to the initiation of the study. However, a co-supervisor (Erika Franzén, Sweden) affiliated to the project might receive some relevant pseudonymized data. If that is the case, the protocol description will be updated.
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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.
Ulrik Dalgas, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WALK, ACTIVE and CON in people with Parkinson Disease, run by University of Aarhus at 1 site in Denmark.
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 6 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: looking for participants now, as of the sponsor's last update on 3 Jul 2025. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frederik B Jensen, MSc (+4521268252, fbj@ph.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Generic Walking Scale - 12 items (Walk-12G) (time frame: From enrollment to the end of follow-up at 48 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 NCT06707402, which also lists 42 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 3 Jul 2025.