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

May 12, 2022 updated by: Izaro Esain, University of the Basque Country (UPV/EHU)

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

Completed

Conditions

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

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Bizkaia
      • Leioa, Bizkaia, Spain, 48903
        • University of the Basque Country

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2021

Primary Completion (Actual)

October 22, 2021

Study Completion (Actual)

January 14, 2022

Study Registration Dates

First Submitted

May 9, 2022

First Submitted That Met QC Criteria

May 12, 2022

First Posted (Actual)

May 17, 2022

Study Record Updates

Last Update Posted (Actual)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 12, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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

Clinical Trials on Hatha Yoga

Subscribe