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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Hatha Yoga
Stretching
Sponsored by
University of the Basque Country (UPV/EHU)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parkinson Disease focused on measuring Yoga, Stretching, Parkinson disease

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of the basque Country

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Hatha Yoga

Stretching

Arm Description

Participants performed 1 hour supervised Yoga sessions once a week for a total of eight weeks.

Participants performed 1 hour supervised Stretching sessions once a week for a total of eight weeks.

Outcomes

Primary Outcome Measures

Change from baseline in height
Height is going to be assessed by portable stadiometer (Aisemed T226) to determine change from baseline.
Change from baseline in weight
Weight is going to be assessed by digital scale (Seca Model 868) to determine change from baseline.
Change from baseline in Postural control
Postural control, static balance is assessed with an stabilometric platform to determine change from baseline.
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.
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.
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.
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.
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.
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.
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.
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).

Secondary Outcome Measures

Full Information

First Posted
May 9, 2022
Last Updated
May 12, 2022
Sponsor
University of the Basque Country (UPV/EHU)
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1. Study Identification

Unique Protocol Identification Number
NCT05377073
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 14, 2021 (Actual)
Primary Completion Date
October 22, 2021 (Actual)
Study Completion Date
January 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the Basque Country (UPV/EHU)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Yoga, Stretching, Parkinson disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel randomized controlled trial
Masking
Investigator
Masking Description
Participants were randomly assigned (in a 1:1 ratio) through sealed opaque envelopes to either to the yoga group or the stretching group by coin tossing sequence generation.
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hatha Yoga
Arm Type
Experimental
Arm Description
Participants performed 1 hour supervised Yoga sessions once a week for a total of eight weeks.
Arm Title
Stretching
Arm Type
Experimental
Arm Description
Participants performed 1 hour supervised Stretching sessions once a week for a total of eight weeks.
Intervention Type
Other
Intervention Name(s)
Hatha Yoga
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Stretching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in height
Description
Height is going to be assessed by portable stadiometer (Aisemed T226) to determine change from baseline.
Time Frame
8 weeks
Title
Change from baseline in weight
Description
Weight is going to be assessed by digital scale (Seca Model 868) to determine change from baseline.
Time Frame
8 weeks
Title
Change from baseline in Postural control
Description
Postural control, static balance is assessed with an stabilometric platform to determine change from baseline.
Time Frame
8 weeks
Title
Change from baseline in Back Scratch Test
Description
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.
Time Frame
8 weeks
Title
Change from baseline in Chair Sit and Reach Test
Description
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.
Time Frame
8 weeks
Title
Change from baseline in Time Up and Go test (TUG)
Description
Dynamic balance and agility is going to be assessed by Time Up and Go test to determine change from baseline.
Time Frame
8 week
Title
Change from baseline 5 Times Sit to Stand Test
Description
Lower limb strength is going to be assessed by 5 Times Sit to Stand Test to determine change from baseline.
Time Frame
8 weeks
Title
Change from baseline in Walking speed
Description
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.
Time Frame
8 weeks
Title
Change from baseline in motor examination
Description
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.
Time Frame
8 weeks
Title
Change from baseline in Physical Activity
Description
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.
Time Frame
8 weeks
Title
Change from baseline in quality of life score
Description
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).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of the basque Country
City
Leioa
State/Province
Bizkaia
ZIP/Postal Code
48903
Country
Spain

12. IPD Sharing Statement

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

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