Clinical trial NCT05377073: Effects of Complementary Therapies in People With Mild to Moderate Parkinson's Disease
Official title: Effects of Hatha Yoga vs Stretching in People With Mild to Moderate Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Yoga
Stretching
Parkinson disease
Lead sponsor: University of the Basque Country (UPV/EHU)
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 24
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel randomized controlled trial
Primary purpose: PREVENTION

Brief summary: The aim of this study was to compare the effects of Hatha Yoga versus Stretching on physical outcomes, quality of life, physical activity and motor examination in persons with Parkinson Disease.

The hypothesis of this study is that Hatha Yoga will improve more than Stretching on physical outcomes, quality of life, physical activity and on motor examinations in persons with parkinson Diseases

Detailed description: Individuals diagnosed with Parkinson 's disease, signed up at the Parkinson's association in Asparbi (Bilbao, Basque Country), and meeting the inclusion criteria were included in the study. These individuals were randomly assigned (in a 1:1 ratio) through sealed opaque envelopes to either to Hatha Yoga group and Stretching group by coin tossing sequence generation

Both programs consisted of one weekly session for a total of eight weeks.

Hatha Yoga group performed warm-up exercises for 10 minutes, standing, sitting and supine positions of Hatha yoga (30 minutes), and relaxation and breathing exercises (20 minutes).

Stretching group performed warm-up activities (10 minutes), and analytic stretching exercises targeting the following muscles: sternocleidomastoid, splenius, trapeze, triceps, posterior shoulder capsule, paravertebralis, hamstrings, quadriceps, gastrocnemius, soleus and tibialis anterior (40 minutes). Two repetitions of 15 seconds of each stretch were performed, with 15 seconds interval between repetitions. The sessions ended with diaphragmatic breathing exercises (10 minutes).

Demographic information form was filled out by patients including information about: age, height (cm), weight (kg). Additionally, the following measures are going to be measured:

* Postural control is assessed with a stabilometric platform.
* Flexibility ( Back Scratch Test and Chair Sit and Reach Test)
* Time Up and Go test (TUG)
* 5 Times Sit to Stand Test
* Walking speed
* Unified Parkinson´s Diseases Rating Scale III (UPDRS-III)
* International Physical Activity Questionnaires (IPAQ)
* Parkinson´s Disease Questionnaires- 39 (PDQ-39)

SPSS version 22 program was used in the analysis of the data. Mann Whitney U test, Wilcoxon test, Student T test and two-way mixed Anova were used to analyse the results.

Eligibility criteria: Inclusion Criteria:

* Medical diagnosis of Parkinson's disease
* Stages I to III on the Hoehn and Yahr scale
* Ability to stand upright unaided and walk with or without technical support

Exclusion Criteria:

* Participate in another directed physical exercise program during the Project.
* Moderate or severe cognitive decline.

Primary outcomes:
measure: Change from baseline in height
timeFrame: 8 weeks
measure: Change from baseline in weight
timeFrame: 8 weeks
measure: Change from baseline in Postural control
timeFrame: 8 weeks
measure: Change from baseline in Back Scratch Test
timeFrame: 8 weeks
measure: Change from baseline in Chair Sit and Reach Test
timeFrame: 8 weeks
measure: Change from baseline in Time Up and Go test (TUG)
timeFrame: 8 week
measure: Change from baseline 5 Times Sit to Stand Test
timeFrame: 8 weeks
measure: Change from baseline in Walking speed
timeFrame: 8 weeks
measure: Change from baseline in motor examination
timeFrame: 8 weeks
measure: Change from baseline in Physical Activity
timeFrame: 8 weeks
measure: Change from baseline in quality of life score
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Leioa
country: Spain
facility: University of the basque Country
state: Bizkaia
Study officials:
References: