Parkinson DiseasemHEXANUTNCT04945876
Exercise Adherence and Optimal Nutrition Post Rehabilitation Among People With Parkinson's Disease
A study testing Digital follow-up in people with Parkinson Disease, run by Oslo Metropolitan University at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Digital follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 30 Apr 2021to 28 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Digital follow-up
- Keywords
- Parkinson disease, digital follow up, exercise, nutrition
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital follow-upBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Digital follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: measured at baseline, 12 weeks and 6 months
Secondary outcomes (7)
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: 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: 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: 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: 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: 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: 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: measured at baseline, 12 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start30 Apr 2021
- Primary completion23 Jun 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic randomized, controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Unicare Fram, Norwegian Parkinson's Association, Lovisenberg Diaconal University College, Karolinska Institutet, Aalborg University Hospital, Fysiofondet
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945876
- Sponsor's protocol ID
- 201660 mHEXANUT
- Acronym
- mHEXANUT
- Status last verified
- Feb 2024
- First submitted
- 1 Mar 2021
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alnes SR, Laerum-Onsager E, Bye A, Vistven A, Franzen E, Holst M, Brovold T. Post-rehabilitation self-management support on physical activity and nutrition, including mHealth, improves physical capacity, physical activity, and health related quality of life in people with Parkinson's- results from a randomised controlled trial. Int J Behav Nutr Phys Act. 2026 Feb 17;23(1):27. doi: 10.1186/s12966-026-01888-y.
PubMed 41703544Alnes 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.
PubMed 36864377
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mobile Health Technology (mHealth), Exercise Adherence and Optimal Nutrition Post Rehabilitation Among People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04945876
- Acronym / sponsor ID
- mHEXANUT / 201660 mHEXANUT
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, digital follow up, exercise, nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Unicare Fram, Norwegian Parkinson's Association, Lovisenberg Diaconal University College, Karolinska Institutet, Aalborg University Hospital, Fysiofondet
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Pragmatic randomized, controlled trial
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Digital follow-upParticipants 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- >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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital follow-upParticipants 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. | Behavioural | Intervention group |
Primary outcome
Six minute walk test (6MWT)
Time frame: measured at baseline, 12 weeks and 6 months
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.
7 secondary outcomes
The Parkinson's disease questionnaire (PDQ-39)
Time frame: measured at baseline, 12 weeks and 6 months
The Patients-Generated subjective Global Assessment Short Form (PG-SGA)
Time frame: measured at baseline, 12 weeks and 6 months
mini best test
Time frame: measured at baseline, 12 weeks and 6 months
and 5x sit-to-stand
Time frame: measured at baseline, 12 weeks and 6 months
Bioelectrical impedance analysis
Time frame: measured at baseline, 12 weeks and 6 months
What do you eat
Time frame: measured at baseline
Radboud Oral Motor Inventory for Parkinson's disease (ROMP) - swallowing
Time frame: measured at baseline, 12 weeks and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Derived from this study: PubMed 41703544Alnes SR, Laerum-Onsager E, Bye A, Vistven A, Franzen E, Holst M, Brovold T. Post-rehabilitation self-management support on physical activity and nutrition, including mHealth, improves physical capacity, physical activity, and health related quality of life in people with Parkinson's- results from a randomised controlled trial. Int J Behav Nutr Phys Act. 2026 Feb 17;23(1):27. doi: 10.1186/s12966-026-01888-y.
- Derived from this study: PubMed 36864377Alnes 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital follow-up in people with Parkinson Disease, run by Oslo Metropolitan University at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six minute walk test (6MWT) (time frame: measured at baseline, 12 weeks and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04945876, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.