Parkinson Disease Clinical Trial
— mHEXANUTOfficial 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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | August 2023 |
Est. primary completion date | August 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Norway | Unicare Fram Rykkin | Rykkin | Bærum |
Lead Sponsor | Collaborator |
---|---|
Oslo Metropolitan University | Aalborg University Hospital, Fysiofondet, Karolinska Institutet, Lovisenberg Diaconal University College, Norwegian Parkinson's Association, Unicare Fram |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | and 5x sit-to-stand | Assesses functional lower extremity strength, transitional movements, balance and fall risk | measured at baseline, 12 weeks and 6 months | |
Secondary | Bioelectrical impedance analysis | A method for estimating body composition, in particular body fat and muscle mass. | measured at baseline, 12 weeks and 6 months | |
Secondary | 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 | |
Secondary | 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 |
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