- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03752346
Multimodal Exercise Program on Parkinson's Disease Patients With Depression
Effectiveness of Multimodal Exercise Program on Depression and Health-Related Quality of Life in Patients With Parkinson's Disease
Studieoversigt
Detaljeret beskrivelse
Objective: Evaluate the effectiveness of a 8-week multimodal exercise program on depression and HRQOL in PD Patients.
Methods: Single-blinded, randomized controlled trial, from March 2016 to January 2017. Ninety-eight patients recruited to 2 groups: exercise group (n = 49) and control group (n = 49). The primary outcomes were depression and HRQOL; the secondary outcomes were activity of daily living, motor ability, fatigue, sleep quality and anxiety. Data collection at baseline, week 4 and 8 after intervention. Intervention were Multimodal Exercise Program, at least three times (30 - 50 minutes per section) a week or 10-15 minutes per section every day to accumulate 150 minutes a week for 8 weeks.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- be diagnosed PD in Hoehn and Yahr stage I-II22
- under stable medication treatment at least 3 months
- no disease limiting the patient's ability to perform the exercises
Exclusion Criteria:
- severe cardiovascular disorders
- neuromusculoskeletal disorder
- cognitive impairment
- recent participation in any physiotherapy or rehabilitation program
- have exercise regularly
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: control group
Control group maintained their regular lifestyle and received the routine care
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Eksperimentel: exercise group
Participants in the exercise group (EG) were instructed to engage performed exercise at least 3 times per week (30-50 minutes) or 10-15 minutes per section every day to accumulate 150 minutes per week for 8 weeks using disc (DVD) at home.
Main exercise was moderate intensity aerobic exercise, an intensity of 55-70% of the heart rate reserve (HR max).
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A step aerobics exercise lasted a total 30 minutes, including:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
GDS-15
Tidsramme: 3 minutes
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consisting of 15 questions, was the primary outcome evaluator (Sheikh and Yesavage, 1986).
Scores of 0-4 are considered to be normal; 5-8 indicates mild depression; 9-11 indicates moderate depression; and 12-15 indicates severe depression.
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3 minutes
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PDQ-8
Tidsramme: 3 minutes
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A sub-set of items is then selected from the PDQ-39 to create a shorter form version, the PDQ-8 (Jenkinson, Fitzpatrick & Peto, 1997).
The sum of the scores can provide a single figure used to assess the overall health-related quality of life profile of the individual questioned. .
Scores for each dimension range from 0 to 100, PDQ-8SI scores can be standardized on a scale from 0 to 100, with lower scores indicating better HRQoL.
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3 minutes
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
UPDRS part II (ADL)
Tidsramme: 5 minutes
|
The unified Parkinson's disease rating scale (UPDRS) is used to follow the longitudinal course of Parkinson's disease (Fahn & Elton, 1987).
The UPD rating scale is the most commonly used scale in the clinical study of Parkinson's disease.
A total of 199 points are possible (199 represents the worst disability and 0 no disability).
Part II: self-evaluation of the activities of daily life (ADLs).
The scales part 2: motor experiences of daily living (13 items), each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
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5 minutes
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UPDRS part III (motor ability)
Tidsramme: 10 minutes
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The unified Parkinson's disease rating scale (UPDRS) is used to follow the longitudinal course of Parkinson's disease (Fahn & Elton, 1987).
The UPD rating scale is the most commonly used scale in the clinical study of Parkinson's disease.
Its 42 items are evaluated by interview and clinical observation.
The motor section in particular to follow the progression of a person's Parkinson's disease.
A total of 199 points are possible (199 represents the worst disability and 0 no disability).
The scales part 3: motor examination (18 items), each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
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10 minutes
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Fatigue (FSS)
Tidsramme: 5 minutes
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The Fatigue Severity Scale is a 9-item scale which measures the severity of fatigue (Krupp, LaRocca, Muir-Nash, & Steinberg, 1989).
The subject is asked to read each statement and circle a number from 1 to 7, the items are scored on a 7 point scale with 1=strongly disagree and 7=strongly agree.
The minimum score=9 and maximum score possible=63.
Higher the score=greater fatigue severity.
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5 minutes
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Sleep quality (PSQI)
Tidsramme: 5 minutes
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The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults (Buysse, Reynolds, Monk, Berman, & Kupfer, 1989).
It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month.
A total score of "5" or greater is indicative of poor sleep quality.
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5 minutes
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Anxiety (HAS)
Tidsramme: 3 minutes
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The Hospital Anxiety Scale (HAS), a self-assessment scale, was developed to detect states of, anxiety and emotional distress, used to screen for the presence of anxiety, in a general medical population of patients (Zigmond & Snaith, 1983).
Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety.
For both scales, scores of less than 7 indicate normal, 8-10 indicate mild anxiety, 11-14 indicate moderate anxiety and 15-21 severe anxiety.
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3 minutes
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 151223
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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