NCT01984593

Brief Summary

The purpose of this study is to determine the effects of a short yoga program practiced daily at home on blood pressure, quality of Life and stress. The subjects of the study are primary health care patients diagnosed with hypertension, with or without current medication.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 14, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

November 5, 2014

Status Verified

November 1, 2014

Enrollment Period

4 months

First QC Date

November 8, 2013

Last Update Submit

November 4, 2014

Conditions

Keywords

YogaHypertensionQuality of LifePrimary Health CareStressAnxietyDepression

Outcome Measures

Primary Outcomes (1)

  • Hypertension

    At the beginning of the study, all subjects will undergo a standardized blood pressure test with an hypertension monitor. After 12 weeks, all subjects in the intervention and control groups will again be requested to attend a blood pressure testing session

    12 weeks

Secondary Outcomes (1)

  • Quality of life

    12 weeks

Other Outcomes (2)

  • Stress

    12 weeks

  • Anxiety and depression

    12 weeks

Study Arms (2)

Control

NO INTERVENTION

No changes will be made for the participants in the control group, but they will undergo the same measurements and evaluations as the intervention group.

yoga

ACTIVE COMPARATOR

Two yoga exercises to perform at home 15 minutes twice daily.

Other: Yoga

Interventions

YogaOTHER

The participants in the Yoga group will get a private doctors appointment (20 minutes) where they get instructions for two yoga exercises to perform at home 15 minutes twice a day. The two yoga exercises were: 1. "Left nostril breathing" - deep breaths in and out through the left nostril while sitting or lying down, with the right nostril closed off by the right thumb or an earplug (about 11 minutes); and 2. "Spinal flex" - movement that alternates between flexing the spine forwards (arching) and relaxing the spine back in time with deep breaths while sitting in a chair (about 4 minutes).

yoga

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Diagnosed with hypertension since at least one year
  • Blood pressure 130-160 mm Hg systolic and/or 85-100 diastolic at the last blood pressure control by doctor or nurse.

You may not qualify if:

  • Blood pressure outside the range of 120-180 systolic and 80-110 diastolic at the last blood pressure control or at baseline control.
  • Medical adjustments regarding hypertension within 4 weeks prior to begin of study.
  • Expected inability to understand instructions about yoga exercises (e.g dementia and mental retardation) or physical or psychical inability to carry out yoga exercises (e.g severe physical or psychical handicap).
  • Need for interpreter. Linguistic/language difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Primary Health Care Research, Lunds University

Malmo, 20502, Sweden

Location

MeSH Terms

Conditions

HypertensionAnxiety DisordersDepression

Interventions

Yoga

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Moa Wolff, MD

    Center for Primary Health Care Research, Lunds University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Practitioner

Study Record Dates

First Submitted

November 8, 2013

First Posted

November 14, 2013

Study Start

November 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

November 5, 2014

Record last verified: 2014-11

Locations