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

Effect of Mobile Health Technology (mHealth), Exercise Adherence and Optimal Nutrition Post Rehabilitation Among People With Parkinson's Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Behavioral: Digital follow-up

Detailed Description

It is found that regular, structured exercise is especially important for people with Pakinson disease (PD) and it is a key element in the treatment of PD at rehabilitation centers in Norway. A substantial amount of research indicate that exercise can lead to improvements in physical functioning, strength, balance, gait, and HRQOL among people with PD. However, after a supervised exercise period, these measures tend to return toward baseline values. This regression may to some extent reflect the progressive nature of PD, but previous research suggests that maintaining the motivation to stay physically active is difficult once formalized interventions end. Furthermore, research indicate that nutritional status is an important predictor for health status among people with PD and that PD patients have high rates of unintentional weight loss compared to age-matched controls. In other words, research indicate that follow-up at home after rehabilitation is necessary to increase optimal nutrition and continuing to exercise.

This is a randomized controlled trial meant to evaluate the effect of six months digital follow-up, after a 3-5 week stay at a inpatient rehabilitation center, on functional and nutritional status in people with PD.

Eligible participants will be recruited from Unicare Fram Rehabilitation center by a physical therapist and research assistant in collaboration with Unicare Fram employees and a Ph.D student. Informed consent from the participants is obtained from persons with no previous relationship to the patients, and who are not included in their daily treatment, mainly the research assistant. After baseline testing the participants will be randomly allocated to an intervention- or control group.

The intervention in this study is designed to increase the level of adherence after rehabilitation by implementing factors that previous studies have proven successful such as education, goal setting, follow-up from health care personnel and use of mHealth Technology. The intervention consist of 2 phases.

Phase 1: All participants will receive the rehabilitation program currently provided at Unicare Fram rehabilitation center. This is a comprehensive and interdisciplinary rehabilitation program with focus on self-management of the disease including exercise and nutrition.

Phase 2: The control group will receive no further follow-up. The intervention group will receive digital follow up once a month focusing on goals and motivation, and an activity tracker and instructions on how to use it both for motivation, daily activity tracking, logging of specific exercise and intensity control.

All participants will be retested after 12 weeks and 6 months at Unicare Fram rehabilitation center by the research assistant.

Descriptive data will be reported for variables of interest. The data will be analyzed following the intention to treat principle. Prospective differences in primary and secondary outcomes and baseline characteristics between the intervention group and the control group will be assessed by t-tests for continuous and normal distributed variables and with non-parametric tests for categorical variables. Multiple linear and logistic regression modelling will be used to control for confounding of between-group differences. The latest version of Statistical Package of the Social Sciences (SPSS) will be used.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sigrid R Alnes, MSc; Phone Number: +4747648388; Email: sigridry@oslomet.no
• Study Contact Backup: Name: Therese Brovold, Ph.D; Phone Number: 47238558; Email: therbrov@oslomet.no

Study Locations

• Norway
  • Bærum
    • Rykkin, Bærum, Norway, 1349
      • Recruiting
      • Unicare Fram Rykkin
      • Contact: Annette F Vistven; Phone Number: 92461400; Email: annettev@oslomet.no
      • Contact: Helene Haakand; Phone Number: 48028311; Email: helene.haaland@unicare.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• >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

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control group; 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.
EXPERIMENTAL: Intervention group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Parkinson's disease questionnaire (PDQ-39)	A 39 item, patient reported measure of health status and quality of life over the last month. It assesses how often people affected by parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication. The answers results in a score from 0-100 points in each dimension. Lower scores reflect better QoL.	measured at baseline, 12 weeks and 6 months
The Patients-Generated subjective Global Assessment Short Form (PG-SGA)	It is a component of a nutritional assessment tool wich could be used for descriptive nutrition screening. A 4 item questionnaire assessing weight, food-intake, symptoms affecting food intake and activity & function. The answers result in a score from 0-9, 0 indicates no need for nutritional measures, 9 indicates a critical need for nutritional measures.	measured at baseline, 12 weeks and 6 months
mini best test	The test is used to identify risk of falling, changes in balance over time and distinguish between different balance challenges.	measured at baseline, 12 weeks and 6 months
and 5x sit-to-stand	Assesses functional lower extremity strength, transitional movements, balance and fall risk	measured at baseline, 12 weeks and 6 months
Bioelectrical impedance analysis	A method for estimating body composition, in particular body fat and muscle mass.	measured at baseline, 12 weeks and 6 months
What do you eat	A food frequency questionnaire used to assess the diet of a population during the last seven days. Contains questions on how often and how much you eat of specific food groups. The questionnaire does not result in a score. it can be used to raise awareness and to assess on what areas potential nutritional measures is needed.	measured at baseline
Radboud Oral Motor Inventory for Parkinson's disease (ROMP) - swallowing	A self-report questionnaire with 7 questions assessing potential swallowing difficulties. The answers results in a score from 7-35 point. A low score indicates little to no problems with swallowing, i high score indicates a higher degree of problems with swallowing.	measured at baseline, 12 weeks and 6 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 30, 2021
• Primary Completion (ANTICIPATED): August 1, 2023
• Study Completion (ANTICIPATED): August 1, 2023

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (ACTUAL): June 30, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 10, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: exercise; nutrition; Parkinson disease; digital follow up
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 201660 mHEXANUT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No