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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
| Viborg Regional Hospital | OTHER |
| Danish Parkinson Association | OTHER |
| Fonden af 2. Juli 1984 til bekæmpelse af Parkinsons Sygdom, Denmark |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WALK | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | From enrollment to the end of follow-up at 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | From enrollment to the end of follow-up at 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Figure-of-8 Walk Test (F8W) | The F8W is included to motivate participants in the WALK group to sustain active. The test would be conducted at baseline (after randomization) and midway through the intervention period (12 weeks). By seeing progress (i.e., improved test performance) the participant would be motivated to sustain active. Otherwise, if no improvement is detected, the training program would be reevaluated for the participant to increase the likelihood of an improved walking function (i.e., improved Walk-12G score) after 24 weeks. |
Inclusion Criteria:
Exclusion Criteria:
Cisgender
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frederik B Jensen, MSc | Contact | +4521268252 | fbj@ph.au.dk | |
| Ulrik Dalgas, Professor | Contact | dalgas@ph.au.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University, Department of Public Health, Sport Science | Recruiting | Aarhus C | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33794786 | Background | 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. | |
| 27702555 | Background | Frost 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. |
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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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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| OTHER |
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|
| ACTIVE | Behavioral | 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 | Behavioral | Receives a brief educational session (walking advice) is provided at baseline, after which no further contacts are made. |
|
| Chair rise | Linear encoder equipment is used to measure muscle force and muscle power during a chair rise. | 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). | 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 | 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. | 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 | 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 | 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 | 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. | 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) | 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. | 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. | 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. | 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) | 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. | 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). | 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. | Baseline only |
| Major Depression Inventory (MDI) (questionnaire) | It assesses depression symptoms. Scores ranged from 0 (no depression) to 50 (severe depression) | 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) | 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). | 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) | 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) | 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). | 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) | From enrollment to the end of follow-up at 48 weeks |
| Baseline and midway through the intervention (12 weeks) |
| Motivational telephone calls | Both WALK and ACTIVE will receive motivational telephone calls. By the end of the call, three questions (yes/no answer) would be asked to the participants to assess the degree of motivation through the intervention period and follow-up period. In total 8 telephone calls would be conducted (5 during the intervention period and 3 during the follow-up period) The questions are:
| From enrollment to the end of follow-up at 48 weeks |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |