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

NCT06707402 | Recruiting DMC

• 1 other identifier: Walking and PD
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Brisk walking; Walking difficulty

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (24)

• Demographic measures

  From enrollment to the end of follow-up at 48 weeks

• 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

  From enrollment to the end of follow-up at 48 weeks

• Mini Balance Evaluation Systems Test (MiniBESTest)

  From enrollment to the end of follow-up at 48 weeks

• Timed-up and Go (TUG)

  From enrollment to the end of follow-up at 48 weeks

Other Outcomes (2)

• Figure-of-8 Walk Test (F8W)

  Baseline and midway through the intervention (12 weeks)

• Motivational telephone calls

  From enrollment to the end of follow-up at 48 weeks

Study Arms (3)

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.

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.

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.

Behavioral: CON

Interventions

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

Combined individual home-based and supervised group-based walking exercise

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.

Individual home-based exercise

CON BEHAVIORAL

Receives a brief educational session (walking advice) is provided at baseline, after which no further contacts are made.

Control group

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Cisgender
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• Karolinska Institutet: collaborator
• Viborg Regional Hospital: collaborator
• Danish Parkinson Association: collaborator
• Fonden af 2. Juli 1984 til bekæmpelse af Parkinsons Sygdom, Denmark: collaborator

Study Sites (1)

Aarhus University, Department of Public Health, Sport Science

Aarhus C, 8000, Denmark

RECRUITING

Related Publications (42)

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MeSH Terms

Conditions

Parkinson Disease; Mobility Limitation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Frederik B Jensen, MSc

CONTACT

+4521268252; fbj@ph.au.dk

Ulrik Dalgas, Professor

CONTACT

dalgas@ph.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 27, 2024
• Study Start: March 11, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 3, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)