- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05377073
Effects of Complementary Therapies in People With Mild to Moderate Parkinson's Disease
Effects of Hatha Yoga vs Stretching in People With Mild to Moderate Parkinson's Disease
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bizkaia
-
Leioa, Bizkaia, Spain, 48903
- University of the Basque Country
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hatha Yoga
Participants performed 1 hour supervised Yoga sessions once a week for a total of eight weeks.
|
Patients in the 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).
The program consisted of one weekly session for a total of eight weeks.
|
|
Experimental: Stretching
Participants performed 1 hour supervised Stretching sessions once a week for a total of eight weeks.
|
Patients in the 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 a 15 seconds interval between repetitions.
The sessions ended with diaphragmatic breathing exercises (10 minutes).
The program consisted of one weekly session for a total of eight weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in height
Time Frame: 8 weeks
|
Height is going to be assessed by portable stadiometer (Aisemed T226) to determine change from baseline.
|
8 weeks
|
|
Change from baseline in weight
Time Frame: 8 weeks
|
Weight is going to be assessed by digital scale (Seca Model 868) to determine change from baseline.
|
8 weeks
|
|
Change from baseline in Postural control
Time Frame: 8 weeks
|
Postural control, static balance is assessed with an stabilometric platform to determine change from baseline.
|
8 weeks
|
|
Change from baseline in Back Scratch Test
Time Frame: 8 weeks
|
Flexibility of the upper limb is going to be assessed by the test of the Senior Fitness Test Back Scratch Test, to determine change from baseline.
|
8 weeks
|
|
Change from baseline in Chair Sit and Reach Test
Time Frame: 8 weeks
|
Flexibility of the lower limb is going to be assessed by the test of the Senior Fitness Test Chair Sit and Reach Test, to determine change from baseline.
|
8 weeks
|
|
Change from baseline in Time Up and Go test (TUG)
Time Frame: 8 week
|
Dynamic balance and agility is going to be assessed by Time Up and Go test to determine change from baseline.
|
8 week
|
|
Change from baseline 5 Times Sit to Stand Test
Time Frame: 8 weeks
|
Lower limb strength is going to be assessed by 5 Times Sit to Stand Test to determine change from baseline.
|
8 weeks
|
|
Change from baseline in Walking speed
Time Frame: 8 weeks
|
Walking speed is going to be assessed by walking 12 m, and photocells will be placed at 1 m and 11 m, recording time of 10 m to determine change from baseline.
|
8 weeks
|
|
Change from baseline in motor examination
Time Frame: 8 weeks
|
Motor examination is going to be assessed by Unified Parkinson´s Diseases Rating Scale III to determine change form baseline.
A higher score means a worse motor state.
Total score subscale is 68.
|
8 weeks
|
|
Change from baseline in Physical Activity
Time Frame: 8 weeks
|
Physical activity is going to be assessed by International Physical Activity Questionnaires to determine change from baseline.
Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (Metabolic equivalent of task minutes a week).
Metabolic equivalent of task minutes represent the amount of energy expended carrying out physical activity.
|
8 weeks
|
|
Change from baseline in quality of life score
Time Frame: 8 weeks
|
Quality of life score is going to be assess by Parkinson´s Disease Questionnaires- 39 to determine change from baseline.
It has eight dimensions that are coded on a scale of 0 (perfect health as assessed by the measure) to 100 (worse health as assessed by the measure).
|
8 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Esain I. Parkinson
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson Disease
-
Bezmialem Vakif UniversityRecruitingParkinson Disease | Parkinson | Parkinson Disease (PD) | PARKINSON DISEASE (Disorder) | Parkinson s DiseaseTurkey (Türkiye)
-
CND Life SciencesDigestive Disease Associates of CTRecruitingParkinson Disease | Parkinson | PARKINSON DISEASE (Disorder) | Parkinson s DiseaseUnited States
-
Neuron23 Inc.Roche Diagnostic Ltd.; Qiagen Manchester LimitedRecruitingParkinson Disease | Parkinson | Idiopathic Parkinson Disease | Parkinson Disease, Idiopathic | Early Parkinson Disease (Early PD)United States, Spain, Israel, Poland, Italy, United Kingdom
-
San Francisco Neurology and Sleep CenterNot yet recruitingPARKINSON DISEASE (Disorder) | Parkinson s DiseaseUnited States
-
Haukeland University HospitalUniversity of Bergen; SPARK NSRecruitingParkinson Disease (PD) | Parkinson s DiseaseNorway
-
Bezmialem Vakif UniversityIstanbul University - CerrahpasaNot yet recruitingParkinson Disease | PARKINSON DISEASE (Disorder) | Parkinson Disease (PD), Postural Balance
-
CND Life SciencesOregon Health and Science UniversityRecruitingParkinson Disease | Parkinson | Parkinson's Disease and Parkinsonism | PARKINSON DISEASE (Disorder)United States
-
Università degli Studi dell'InsubriaUniversidade Nova de Lisboa; Associazione Parkinson Insubria (AsPI), Section... and other collaboratorsRecruitingParkinson Disease | Parkinson | Parkinson Disease, Idiopathic | PARKINSON DISEASE (Disorder)Italy
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedParkinson Disease 6, Early-Onset | Parkinson Disease (Autosomal Recessive, Early Onset) 7, Human | Parkinson Disease Autosomal Recessive, Early Onset | Parkinson Disease, Autosomal Recessive Early-Onset, Digenic, Pink1/Dj1United States
-
Duke UniversityMedical University of South Carolina; Massachusetts General Hospital; Mayo Clinic and other collaboratorsNot yet recruitingGut Microbiota | Gut Microbiome | Parkinson Disease (PD) | PARKINSON DISEASE (Disorder) | Prodromal Parkinsons DiseaseUnited States
Clinical Trials on Hatha Yoga
-
University of MinnesotaThe John A. Hartford Foundation; St. Catherine University; Midwest Nursing Center...CompletedQuality of Life | Osteoarthritis, Knee | Poor Quality Sleep | Physical ImpairmentUnited States
-
University of MinnesotaCompleted
-
University of Texas at AustinCompleted
-
Universität Duisburg-EssenCompleted
-
Brown UniversityNational Center for Complementary and Integrative Health (NCCIH); Butler HospitalCompleted
-
Massachusetts General HospitalBrown UniversityCompletedDepression | Mood Disorders | Bipolar DisorderUnited States
-
Rob RutledgeNova Scotia Health Authority; Dalhousie University; IWK Health CentreCompleted
-
Southern Methodist UniversityCompletedDepression | Anxiety | Psychological Distress | Physiological StressUnited States
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN