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AzTrials

Chronic DiseaseTELEYOGANCT03703609

Effects of Tele-yoga in Long-term Conditions

A study testing Tele-yoga in people with Chronic Disease, run by Linkoeping University at 4 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Long-term illness is common in the Swedish population, especially among older people. These conditions are often associated with impaired quality of life due to high physical and psychological symptom-burden. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Disease
What is being tested?
Tele-yoga
Could I receive a placebo?
No, everyone receives an active treatment
How many people
311 participants
Where
4 sitesSweden
Study dates
15 Oct 2018to 31 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Long-term illness and cared for at the cardiology clinic or intensive care clinic for at least 48 hours in the last 3-36 months.
  • Clinically stable condition at the inclusion.

Who cannot join

  • Inability to fill in questionnaires.
  • Inability to participate in the intervention.
  • Expected survival of less than 6 months.

Trial locations and contacts

4 sites in 1 country.

Sweden4 sites

  • Mälardals hospital

    Eskilstuna

  • Ryhov hospital

    Jönköping

  • Linköpings University hospital

    Linköping

  • Vrinnevi Hospital

    Norrköping

Other trials in Sweden

About this study

Official title: Effects of Tele-yoga on Physical Function, Health-related Quality of Life, Symptoms of Anxiety and Depression in Long-term Conditions

Long-term illness is common in the Swedish population, especially among older people. These conditions are often associated with impaired quality of life due to high physical and psychological symptom-burden. Medical Yoga is a therapeutic form of Kundalini Yoga with simple movements, breathing exercises and meditation. For people with serious long-term illness, it can be difficult to attend regular yoga-classes. In this study, the investigators therefore set out to develop a tele-yoga intervention and evaluate the impact of medical yoga remotely at home with regard to physical function, quality of life, symptoms of anxiety and depression, biomarkers, sleep and cognition in people with long-term conditions. Health care utilisation as well as satisfaction and experiences with the exercise form and technology used will also be assessed. The evaluation will be conducted in 150 people with long-term illness recruited from three hospitals (one university hospital and two county hospital) randomised to receive either an intervention with medical yoga remotely at home (tele-yoga) for 12 weeks or a control group receiving individualised training to the same extent. The tele-yoga intervention will be provided remotely in the home via a video-transferred yoga instructor twice a week using a tablet and an app for individual daily exercise. Data will be collected at baseline, after 3 and 6 months.

Despite evidence that physical activity improves quality of life and functional capacity and probably survival, it is difficult to motivate and enable elderly people with long-term conditions to engage in physical and mental rehabilitation. In this study, we will test whether a new method conveyed through a technical solution remotely can increase patients' activity and well-being through allowing tele-yoga at home. Can health care resources be reduced, financial gains can also be made.

The study aims to evaluate the impact of medical yoga remotely at home with regard to physical function, quality of life, symptoms of anxiety and depression, biomarkers, sleep and cognition in people with long-term conditions. The investigators will also measure health care utilisation as well as satisfaction and experiences with the exercise form and technology used. The evaluation will be conducted in 300 people with long-term illness randomised to either tele-yoga or a control group.

Read the detailed description

A sub-study will be conducted exploring physiological effects of yoga in participants with heart failure. The sub-study will include 40 of the patients with heart failure included in the main study. In the sub-study six additional measures will be performed at baseline and after 3 months in 20 study participants with heart failure in the intervention group; ergospirometry, echocardiography, Holter ECG, microcirculation using the epos system, maximal inspiratory and expiratory pressure. There will be four additional measures in 20 participants from the control-group at baseline and after 3 months; Holter ECG, microcirculation using the epos system and maximal inspiratory and expiratory pressure.

Conditions
Chronic Disease
Being tested
Tele-yoga
Keywords
yoga, rehabilitation, physical activity, quality of life, anxiety, depression
Medical subject headings
Chronic Disease, Motor Activity, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tele-yogaBehavioural

    Participants will get a 60 min tele-yoga session biweekly led by a certified medical yoga instructor via live videoconference link on the participants tablet. Each participant will perform a total of 20-24 yoga instructor-led sessions over a 12-week period. A session will contain 10 min breathing exercises, 40 min of yoga and 10 min relaxation/meditation. Before and at the end of each session, participants can discuss their experiences or ask questions to the instructor online. The tablet also includes an app with instructions (text, pictures, and sound files) for yoga positions, breathing and meditation. Participants are encouraged to practice yoga at home individually with one goal of one session a day for a minimum of 10 minutes.

Study groups in NCT03703609
Study groupRoleWhat they receive
Tele-yogaExperimentalIntervention of doing medical yoga at home (tele-yoga) using (1) an online videoconference system (zoom) for particpating in group-yogaled by a live yoga instructor for 60 minutes twice a week and (2) daily individual yoga for a minimum of 10 minutes using a yoga-app. Participants are provided with a tablet with conference system zoom and yoga app for 12 weeks
Receives: Behavioral: Tele-yoga
Individual physical activty adviceNo interventionThe active control group will receive advice to be physically active that corresponds to the intervention group in time and effort, equivalent to 60 minutes for 2 days a week and a minimum of 10 minutes for 5 days a week. To compensate for the extra attention received by the intervention group by the instructor via tele-yoga group, the participants in the activecontrol group's patients will be dialed or have SMS contact (the participant chooses a type of contact) with a physiotherapist or nurse after 2, 4, 8 and 12 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite end-point including physical fuction, health-related quality of life and symptoms of anxiety and depression.

    The composite weighed score consists of physical ability (6 min walking test), Health-realted quality of Life (EQ-5D) and symptom of anxiety and depression (HADS). Based on the change in these 3 variables, a patient can get a score between -3 and + 3 based on the increase, decrease or no change in 6 min walk test, HADS, and EQ5D. The weighted variable will be categorised as improved, deteriorated or unchanged after 3 months.

    Measured: 3 months

Secondary outcomes (11)

  1. Aerobic capacity/endurance

    6 min walk test is a sub-maximal exercise test used to assess aerobic capacity and endurance. Measures the distance in meters covered over a time of 6 minutes

    Measured: 3 and 6 months

  2. Symptoms of Anxiety and Depression

    Hospital anxiety and depression scale is a 14 item scale that generates ordinal data 0-3. Seven of the items relate to anxiety, range 0-21 and seven relate to depression, range 0-21.

    Measured: 3 and 6 months

  3. Health-related quality of life

    The EQ-5D comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The responses generate ordinal data from 1-5 for each dimension. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale 0-100 mm, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.

    Measured: 3 and 6 months

  4. Physical activity

    Actigraph

    Measured: 3 and 6 months

  5. Cognition

    Montreal Cognitive Assessment including short-term memory, visual abilities, executive functions, attention, concentration, working memory, language and orientation to time and place. Scores range between 0 and 30. A score of 26 or over is considered to be normal.

    Measured: 3 and 6 months

  6. Sleep

    Minimal insomnia symptom scale is a sleep questionnaire with 3 items that generates ordinal data. Range 0-12.

    Measured: 3 and 6 months

  7. Exercise Motivation

    The Exercise Motivation Index includes 15 items that generates ordinal data on the motives of participating in physical exercise. Range 0-60.

    Measured: 3 and 6 months

  8. Lower body strength

    Sit to stand test measure the number of uprising from a chair during 30 seconds.

    Measured: 3 and 6 months

  9. Gait speed

    Gait speed test meaures the time it takes in seconds to walk 10 meter at self-selected pace.

    Measured: 3 and 6 months

  10. Health Health

    One general health question from RAND 36 genreating an ordinal data response from 1 (poor health)-5 (excellent health).

    Measured: 3 and 6 months

  11. Life satisfaction

    Cantril ladder of Life is a measurement technique that asks people to rate their present, past, and anticipated future satisfaction with life on a scale anchored by their own identified values from 1 to 10.

    Measured: 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2018
  2. Study start15 Oct 2018
  3. Primary completion31 May 2023
  4. Study completion31 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study is a single-blind parallel two-arm randomized controlled study with 1:1 distribution to intervention and control group. In total 300 persons with long-term conditions will be recruited from three hospitals and randomized to an intervention of medical yoga at home (tele-yoga) using a live videoconference link and a yoga-app on the participants tablet for 12 weeks or a control group receiving individual advice of physical activity. Data will be collected at baseline measurement, after 3 and 6 months.
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
311 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03703609
Sponsor's protocol ID
2017/225-31
Acronym
TELEYOGA
Status last verified
Nov 2023
First submitted
7 Oct 2018
Last updated
22 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hedbom T, Liljeroos M, Thylen I, Orwelius L, Jaarsma T, Stromberg A. Expectations of Tele-Yoga in Persons With Long-Term Illness: Qualitative Content Analysis. J Med Internet Res. 2023 Sep 13;25:e36808. doi: 10.2196/36808.

    PubMed 37703082

Questions about this trial

What is this clinical trial studying?

A study testing Tele-yoga in people with Chronic Disease, run by Linkoeping University at 4 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite end-point including physical fuction, health-related quality of life and symptoms of anxiety and depression. (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03703609, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.

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