Clinical trial NCT04945876: Exercise Adherence and Optimal Nutrition Post Rehabilitation Among People With Parkinson's Disease
Official title: Effect of Mobile Health Technology (mHealth), Exercise Adherence and Optimal Nutrition Post Rehabilitation Among People With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson disease
digital follow up
exercise
nutrition
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
Collaborators: name: Unicare Fram
name: Norwegian Parkinson's Association
name: Lovisenberg Diaconal University College
name: Karolinska Institutet
name: Aalborg University Hospital
name: Fysiofondet
First posted: 2021-06-30
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic randomized, controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Six minute walk test (6MWT)
timeFrame: measured at baseline, 12 weeks and 6 months
Secondary outcomes:
measure: The Parkinson's disease questionnaire (PDQ-39)
timeFrame: measured at baseline, 12 weeks and 6 months
measure: The Patients-Generated subjective Global Assessment Short Form (PG-SGA)
timeFrame: measured at baseline, 12 weeks and 6 months
measure: mini best test
timeFrame: measured at baseline, 12 weeks and 6 months
measure: and 5x sit-to-stand
timeFrame: measured at baseline, 12 weeks and 6 months
measure: Bioelectrical impedance analysis
timeFrame: measured at baseline, 12 weeks and 6 months
measure: What do you eat
timeFrame: measured at baseline
measure: Radboud Oral Motor Inventory for Parkinson's disease (ROMP) - swallowing
timeFrame: measured at baseline, 12 weeks and 6 months
Other outcomes:
Locations:
city: Rykkin
country: Norway
facility: Unicare Fram Rykkin
state: Bærum
Study officials:
References: