NCT01302535

Brief Summary

The purpose of this study is to determine the effects of yoga on blood pressure and quality of life in patients in primary health care diagnosed with hypertension within the last year. Another purpose is to examine whether the possible effect on blood pressure differs if patients practice yoga in a group lead by a yoga-trainer or receive a few yoga-exercises from their doctor to be practiced individually at home.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Mar 2011

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 24, 2011

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

February 23, 2012

Status Verified

February 1, 2012

Enrollment Period

3 months

First QC Date

February 22, 2011

Last Update Submit

February 22, 2012

Conditions

Hypertension

Keywords

YogaHypertensionQuality of LifePrimary Health Care

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. Blood samples will also be collected and analysed in the beginning and at the end of the study. Some blood samples will be preserved for future analysis.

    12 weeks

Secondary Outcomes (1)

  • Quality of life

    12 weeks

Study Arms (3)

Yoga group with supervision/trainer

ACTIVE COMPARATOR
Other: Yoga group with supervision (trainer)

Yoga at home

ACTIVE COMPARATOR
Other: Yoga at home

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 groups.

Interventions

Yoga group with supervision (trainer)OTHER

The Yoga-with-trainer group will meet once a week (60 minutes) to practice yoga with a yoga instructor. The participants will be encouraged to practice yoga between the yoga classes at home for 30 minutes a day.

Yoga group with supervision/trainer
Yoga at homeOTHER

The participants in the Yoga-at-home group will get a private doctor appointment (20 minutes) where they get instructions for two yoga exercises which they are encouraged to perform at home 15 minutes a day.

Yoga at home

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with hypertension since at least one year.
  • Blood pressure 120/80-160/100 mmHg at the last blood pressure control by doctor or nurse.

You may not qualify if:

  • Blood pressure \>180 systolic and/or \>110 diastolic by the initial control in the study.
  • Blood pressure \<120 systolic by the initial control in the study.
  • 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
  • Older than 80 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Primary Health Care Research, Lunds University

Malmo, 20502, Sweden

Location

Related Publications (2)

  • Wolff M, Memon AA, Chalmers JP, Sundquist K, Midlov P. Yoga's effect on inflammatory biomarkers and metabolic risk factors in a high risk population - a controlled trial in primary care. BMC Cardiovasc Disord. 2015 Aug 19;15:91. doi: 10.1186/s12872-015-0086-1.

    PMID: 26286137DERIVED

  • Wolff M, Sundquist K, Larsson Lonn S, Midlov P. Impact of yoga on blood pressure and quality of life in patients with hypertension - a controlled trial in primary care, matched for systolic blood pressure. BMC Cardiovasc Disord. 2013 Dec 7;13:111. doi: 10.1186/1471-2261-13-111.

    PMID: 24314119DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Organization and Administration

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Health Services Administration

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

February 22, 2011

First Posted

February 24, 2011

Study Start

March 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

February 23, 2012

Record last verified: 2012-02

Locations

SE(1)