The Effects of 24-Weeks Community-based Brisk Walking in People With Parkinson's Disease
NCT ID: NCT06707402
Last Updated: 2025-07-03
Study Results
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Basic Information
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RECRUITING
NA
129 participants
INTERVENTIONAL
2025-03-11
2027-09-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Combined individual home-based and supervised group-based walking exercise
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.
WALK
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
Individual home-based exercise
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.
ACTIVE
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.
Control group
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.
CON
Receives a brief educational session (walking advice) is provided at baseline, after which no further contacts are made.
Interventions
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WALK
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
ACTIVE
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.
CON
Receives a brief educational session (walking advice) is provided at baseline, after which no further contacts are made.
Eligibility Criteria
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Inclusion Criteria
2. aged ≥40 years
3. Hoehn and Yahr stage ≤3
4. able to independently undertake transportation back and forth from test days and training sessions
5. expectedly able to complete ≥85% of the training sessions
6. experience walking difficulties (the generic walking scale (Walk-12G) score ≥8.5).
Exclusion Criteria
2. are pregnant
3. have dementia (Montreal Cognitive Assessment score \<18)
4. are suffering from alcohol abuse (i.e., exceeding ten units per week, according to the Danish Health Authority recommendation
5. have cardiovascular, respiratory, orthopedic, or metabolic disorders or other medical comorbidities hindering participation in maximal exercise testing.
6. have a depression
7. use an activity tracker during exercise
8. performing high-intensity brisk walking three or more times during a week.
40 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Viborg Regional Hospital
OTHER
Danish Parkinson Association
OTHER
Fonden af 2. Juli 1984 til bekæmpelse af Parkinsons Sygdom, Denmark
UNKNOWN
University of Aarhus
OTHER
Responsible Party
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Locations
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Aarhus University, Department of Public Health, Sport Science
Aarhus C, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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Walking and PD
Identifier Type: -
Identifier Source: org_study_id
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