Exercise Adherence and Optimal Nutrition Post Rehabilitation Among People With Parkinson's Disease

NCT04945876 | Completed

• 1 other identifier: 201660 mHEXANUT
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, controlled trial to evaluate the effect of six months digital follow-up, after a stay at a rehabilitation center, on functional and nutritional status in people with Parkinson Disease.

Conditions

Parkinson Disease

Keywords

Parkinson disease; digital follow up; exercise; nutrition

Outcome Measures

Primary Outcomes (1)

• Six minute walk test (6MWT)

  A sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. It evaluates the functional capacity of the individual.

  measured at baseline, 12 weeks and 6 months

Secondary Outcomes (7)

• The Parkinson's disease questionnaire (PDQ-39)

  measured at baseline, 12 weeks and 6 months

• The Patients-Generated subjective Global Assessment Short Form (PG-SGA)

  measured at baseline, 12 weeks and 6 months

• mini best test

  measured at baseline, 12 weeks and 6 months

• and 5x sit-to-stand

  measured at baseline, 12 weeks and 6 months

• Bioelectrical impedance analysis

  measured at baseline, 12 weeks and 6 months

Study Arms (2)

Control group

NO INTERVENTION

Participants is encouraged to follow the home-based rehabilitation plan based on the recommendations from the rehabilitation center. No further follow up except for testing at 12 weeks and six months. After the completion of the study the control group will be offered a session of individual exercise and diet guidance as well as a period of digital follow-up as needed.

Intervention group

EXPERIMENTAL

Participants will receive a session of individual exercise and diet guidance with focus on goals and motivation for diet and exercise and help to overcome any barriers for self-efficacy. They will also receive an activity tracker and an introduction on how to use it. Further they will receive a monthly digital follow-up to provide support and address questions and goals regarding nutrition, daily energy expenditure and exercise. The participants can also send sms if they have questions during the follow-up period. They will be encouraged to continue to follow the home-based rehabilitation plan based on the recommendations from the rehabilitation center. If needed they can get help to find suitable exercise groups in their own municipality. The Garmin wristband will be used to facilitate daily activity and continuing exercise at recommended intensity level at home. Participants who are malnourished, or at risk of malnutrition, will receive specific guidance session on nutrition.

Behavioral: Digital follow-up

Interventions

Digital follow-up BEHAVIORAL

Participants will receive: One session of individual exercise and diet guidance focusing on goals and motivation. An activity tracker and instructions on how to use it both for motivation, daily activity tracking, logging of specific exercise and using the wristbands heart rate monitor to control intensity level during exercise. Monthly digital follow-up to provide support and address questions and goals regarding nutrition, daily energy expenditure and exercise. Opportunity to send sms with questions regarding nutrition and exercise. Participants who are malnourished, or at risk of malnutrition will be offered a total of two hours of additional individualized, digital guidance on nutrition as needed.

Intervention group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>40 years
• Living at home
• Living max 2,5 hours travel distance from Unicare Fram
• A diagnosis of idipathic PD
• Hoehn-Yahr stage 1-3
• eternal feeding ability
• must own a smart phone

You may not qualify if:

• Hoehn-Yahr stage 4-5
• Medical issues that might affect participation in exercise programs
• Diagnosis of dementia
• Diagnosis of severe dysphagia
• Exercises regularly more than twice a week(structured exercise).

Sponsors & Collaborators

• Oslo Metropolitan University: lead
• Unicare Fram: collaborator
• Norwegian Parkinson's Association: collaborator
• Lovisenberg Diaconal University College: collaborator
• Karolinska Institutet: collaborator
• Aalborg University Hospital: collaborator
• Fysiofondet: collaborator

Study Sites (1)

Unicare Fram Rykkin

Rykkin, Bærum, 1349, Norway

Location

Related Publications (1)

• Alnes SR, Laerum-Onsager E, Bye A, Vistven A, Franzen E, Holst M, Brovold T. Mobile health technology, exercise adherence and optimal nutrition post rehabilitation among people with Parkinson's Disease (mHEXANUT) - a randomized controlled trial protocol. BMC Neurol. 2023 Mar 2;23(1):93. doi: 10.1186/s12883-023-03134-5.

  PMID: 36864377 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The complex intervention makes masking of participants and care provider impossible. An independent therapist will conduct baseline testing before randomization. The same therapist will conduct the re-testing at 12 weeks and six month, the assessor will be blinded to group allocation and not be part off providing the intervention. The person conducting the data-analyzes will be blinded to group allocation. A computer-generated, permuted block randomization scheme will be used to allocate patients.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic randomized, controlled trial

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: June 30, 2021
• Study Start: April 30, 2021
• Primary Completion: June 23, 2023
• Study Completion: June 28, 2023
• Last Updated: June 25, 2025

Record last verified: 2024-02

Locations

NO (1)