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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
100
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.
Unicare Fram Rykkin
Rykkin, Bærum, Norway
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.
Time frame: measured at baseline, 12 weeks and 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: measured at baseline, 12 weeks and 6 months
and 5x sit-to-stand
Assesses functional lower extremity strength, transitional movements, balance and fall risk
Time frame: measured at baseline, 12 weeks and 6 months
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Bioelectrical impedance analysis
A method for estimating body composition, in particular body fat and muscle mass.
Time frame: 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.
Time frame: 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.
Time frame: measured at baseline, 12 weeks and 6 months