Effects of Complementary Therapies in People With Mild to Moderate Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Effects of Hatha Yoga vs Stretching in People With Mild to Moderate Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05377073
• Other study ID #: Esain I. Parkinson
• Status: Completed
• Phase: N/A
• Start date: September 14, 2021
• Est. completion date: January 14, 2022

Study information

• Verified date: May 2022
• Source: University of the Basque Country (UPV/EHU)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 14, 2022
• Est. primary completion date: October 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Hatha Yoga
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.
• Stretching
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.

Locations

Country	Name	City	State
Spain	University of the basque Country	Leioa	Bizkaia

Sponsors (1)

Lead Sponsor	Collaborator
University of the Basque Country (UPV/EHU)

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in height	Height is going to be assessed by portable stadiometer (Aisemed T226) to determine change from baseline.	8 weeks
Primary	Change from baseline in weight	Weight is going to be assessed by digital scale (Seca Model 868) to determine change from baseline.	8 weeks
Primary	Change from baseline in Postural control	Postural control, static balance is assessed with an stabilometric platform to determine change from baseline.	8 weeks
Primary	Change from baseline in Back Scratch Test	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
Primary	Change from baseline in Chair Sit and Reach Test	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
Primary	Change from baseline in Time Up and Go test (TUG)	Dynamic balance and agility is going to be assessed by Time Up and Go test to determine change from baseline.	8 week
Primary	Change from baseline 5 Times Sit to Stand Test	Lower limb strength is going to be assessed by 5 Times Sit to Stand Test to determine change from baseline.	8 weeks
Primary	Change from baseline in Walking speed	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
Primary	Change from baseline in motor examination	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
Primary	Change from baseline in Physical Activity	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
Primary	Change from baseline in quality of life score	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