The Effects of 24-Weeks Community-based Brisk Walking in People with Parkinson's Disease

Not Applicable

Recruiting

• Conditions: Parkinson Disease

• Registration Number: NCT06707402
• Lead Sponsor: University of Aarhus

Brief 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. 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 Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27
• Study Start: 2025-01-06
• Primary Completion: 2027-07-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

1. clinically diagnosed with Parkinson's disease
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 ≥11.5).

Exclusion Criteria

1. have another neurological disorder or other disorders that affect gait and balance (e.g., severe arthritis or arthrosis)
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Generic Walking Scale - 12 items (Walk-12G)	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)

Secondary Outcome Measures

Name	Time	Method
The Montreal Cognitive Assessment (MoCA) test	From enrollment to the end of follow-up at 48 weeks	Scores from 0 (worse) to 30 (best). Total score are used in the analysis
Demographic measures	From enrollment to the end of follow-up at 48 weeks	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)
Chair rise	From enrollment to the end of follow-up at 48 weeks	Linear encoder equipment is used to measure muscle force and muscle power during a chair rise.
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating scale (MDS-UPDRS) part I, II, III, and IV	From enrollment to the end of follow-up at 48 weeks	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).
Mini Balance Evaluation Systems Test (MiniBESTest)	From enrollment to the end of follow-up at 48 weeks	Assess balance. Scores from 0 (worse) to 28 (best) points
Timed-up and Go (TUG)	From enrollment to the end of follow-up at 48 weeks	Three trials are performed. The fastest trial is used for analysis.
Six-Spot Step Test (SSST)	From enrollment to the end of follow-up at 48 weeks	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
Six-minute walk test (6MWT)	From enrollment to the end of follow-up at 48 weeks	Total distance (m) covered during 6 minutes of fast walking
Symbol Digit Modalities Test (SDMT)	From enrollment to the end of follow-up at 48 weeks	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.
Maximal oxygen consumption test (VO2max test)	From enrollment to the end of follow-up at 48 weeks	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)
Borg scale (part of VO2max test)	From enrollment to the end of follow-up at 48 weeks	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.
Maximal heart rate (part of VO2max test)	From enrollment to the end of follow-up at 48 weeks	Maximal heart rate (beats/min) would be obtained as part of the VO2max test. The highest measure would be used for further analysis.
Physcial activity level	From enrollment to the end of follow-up at 48 weeks	Physical activity level will be assessed using accelerometer (Axivity A3) for 7 consecutive days.
Physical Activity Enjoyment Scale (PACES) (questionnaire)	Only at the post test (24 weeks)	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)
Baecke Physical Activity Questionnaire (BHPAQ) (questionnaire)	From enrollment to the end of follow-up at 48 weeks	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.
EuroQol-5 Domain-5 level (EQ-5D-5L) (questionnaire)	From enrollment to the end of follow-up at 48 weeks	Assess quality of life. Scores in Denmark ranged from -0.757 (worse quality of life) to 1.0 (best quality of life).
Modfied Fatigue Impact Scale (MFIS) (questionnaire)	Baseline only	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.
Major Depression Inventory (MDI) (questionnaire)	From enrollment to the end of follow-up at 48 weeks	It assesses depression symptoms. Scores ranged from 0 (no depression) to 50 (severe depression)
Non-Motor Symptoms Questionnaire (NMSQuest) (questionnaire)	From enrollment to the end of follow-up at 48 weeks	Assess non-motor symptoms and contains 30 items. It scores from 0 (no symptoms) to 30 (severe symptoms)
Parkinsons Disease Questionnaire-39 items (PDQ-39) (questionnaire)	From enrollment to the end of follow-up at 48 weeks	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).
Parkinsons disease Fatigue Scale-16 items (PFS-16) (questionnaire)	From enrollment to the end of follow-up at 48 weeks	Parkinson specific survey that assesses fatigue. Score ranged from 16 (no fatigue) and 80 (severe fatigue)
The Pittsburgh Sleep Quality Index (PSQI) (questionnaire)	From enrollment to the end of follow-up at 48 weeks	Assess sleep quality. Contains 10 items (and some additional items). Score ranged from 0 (no problem) to 21 (severe problem)
Breif Pain Inventory (BPI) (questionnaire)	From enrollment to the end of follow-up at 48 weeks	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).
Falls Efficacy Scale - International (FES-I) (questionnaire)	From enrollment to the end of follow-up at 48 weeks	Assess fear of falling. Contains 16 items. Score ranged from 16 (no fear) to 64 (severe fear)

Trial Locations

Locations (1)

Aarhus University, Department of Public Health, Sport Science; 🇩🇰 Aarhus C, Denmark