Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change in total score of Parkinson's Disease Questionnaire-8 (PDQ-8) |
Minimum score 0, Maximum score 100. A higher score indicates worse quality of life. |
Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks. |
|
| Primary |
Occurence of Emergent Adverse Events |
Occurence of adverse events comprising falls, injuries, muscle soreness or excessive fatigue. |
During the interventional periods (live DfPD® and remote DfPD®) for each participant. |
|
| Primary |
Adherence and Attrition Assessment |
Adherence and attrition rates; an adherence rate =70% is considered as high in elderly with functional limitations, and attrition rate =15% is considered acceptable by the PEDro scale. |
During the intervention (week 2-45) |
|
| Primary |
Assessment of Willingness to Continue the Program after the Intervention |
Verbal statement for continuing the program after the end of the intervention in a 6-point Likert scale (0: i don't know if i'd like to continue the program, 1: i don't want to continue the program at all to 5: i want to continue the program very much). |
End of the program (week 45) |
|
| Primary |
Assessment of Recruitment Rates |
Target, up to 5 months for 40 participants. |
Start of Recruitment (-6 months), Baseline (week 1) |
|
| Secondary |
Change in total score of Parkinson Fatigue Scale-16 (PFS-16) |
Minimum score 1, Maximum score 5. A higher score indicates more fatigue. |
Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks. |
|
| Secondary |
Change in total score of Modified Fatigue Impact Scale (MFIS) |
Minimum score 0, Maximum score 84. A higher score indicates more fatigue. |
Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks. |
|
| Secondary |
Change in total score of Montreal Cognitive Assessment (MoCA) |
Minimum score 0, Maximum score 30. Lower scores indicate cognitive impairment. |
Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks. |
|
| Secondary |
Change in total score of Berg Balance Scale (BBS) |
Minimum score 0, Maximum score 56. Lower scores indicate worse balance. |
Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks. |
|
| Secondary |
Change in Depression Score of Depression, Anxiety and Stress Scale 21 (DASS-21) |
Normal score 0-9, Mild score: 10-12, Moderate score: 13-20, Severe score: 21-27, and Extremely severe: 28-42 |
Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks. |
|
| Secondary |
Change in Anxiety Score of Depression, Anxiety and Stress Scale 21 (DASS-21) |
Normal score 0-6, Mild score: 7-9, Moderate score: 10-14, Severe score: 15-19, and Extremely severe: 20-42 |
Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks. |
|
| Secondary |
Change in Stress Score of Depression, Anxiety and Stress Scale 21 (DASS-21) |
Normal score 0-10, Mild score: 11-18, Moderate score: 19-26, Severe score: 27-34, and Extremely severe: 35-42 |
Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks. |
|
| Secondary |
Change in Patient Outcomes using the Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) |
MDS-UPDRS has 4 parts. Part I assesses non-motor experiences of daily living (13 items, score range: 0-52), part II assesses motor experiences of daily living (13 items, score range: 0-52), part III assesses motor signs (33 items, score range: 0-132), and part IV assesses motor complications, dyskinesias and motor fluctuations (6 items, score range: 0-24). Each item score ranges from 0 (normal) to 4 (severe) and higher scores indicate a greater impact of Parkinson's disease signs. |
Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks. |
|
| Secondary |
Change in total score of SARC-F Scale |
SARC-F is a self-reporting screening tool for the assess of the sarcopenia risk and comprises five components: strength, assistance walking, rise from a chair, climb stairs, and number of falls (score range: 0-2 for each component, and 0-10 in total. Healthy status score range: 0-3, risk of sarcopenia score: =4). |
Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks. |
|
| Secondary |
Change in Sarcopenia status using the European Working Group on Sarcopenia in Older People (EWGSOP2) criteria |
According to EWGSOP2, sarcopenia is (a) probable to an individual with low muscle strength (hand grip strength for men: <27 kg, and women: <16 kg), (b) confirmed to an individual with the above criteria plus low muscle quantity (appendicular skeletal muscle mass index for men: <7 kg/m^2, and women: <5,5 kg/m^2), and (c) severe to an individual with the two above criteria plus low physical performance (4-m usual walking speed test =0.8 m/s). Hand grip strength will be assessed by a calibrated digital handheld dynamometer, appendicular muscle mass index by a bioelectrical impedance analysis (BIA) equipment, and physical performance by the 4-min usual walking speed test. |
Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks. |
|
| Secondary |
Change in Body Mass Index |
A score from the equation kg/m^2. Lower scores than 18,5 indicate underweight, scores of 18,5-24,9 indicate normal weight, scores of 25-29,9 indicate overweight and scores equal or over 30 indicate obesity. Within the obesity category 3 subcategories exist: Class I scores of 30-34, Class II scores of 35-39, and Class III scores of =40. |
Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks. |
|
| Secondary |
Changes in Frailty Phenotype (FP) status |
According to the Fried FP, 5 criteria have to be assessed: unintentional weight loss >5 kg the last year, weakness (handgrip strength for men: <27 kg, and women: <16 kg), slow walking speed (10-m usual walking speed test =0.8 m/s), exhaustion (PFS-16 total score =3, which indicates moderate-to-severe fatigue), and low levels of physical activity (International Physical Activity Questionnaire-Short Form/IPAQ-SF total score <600 MET-min-week^-1, which indicates inactivity). The FP score ranges from 0 to 5 (1 point for each criteria; 0: best score to 5: worst score). As frail defined an individual with a score of =3, as pre-frail an individual with a score of 1-2, and as non-frail or robust an individual with a score 0. |
Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks. |
|
| Secondary |
Registration of Music Preferences via Music Preferences Scale of Gardikiotis & Baltzis |
Music Preferences scale of Gardikiotis & Baltzis is a 6-point Likert scale (0: i don't know it, 1: i don't like it at all to 5: i like it very much) of 24 items (each item includes a different music genre) and evaluates the individual's level of preference to a variety of Greek and non-Greek music. |
Baseline (week 1) |
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