An interventional study of Tele-yoga in Chronic Disease, sponsored by Linkoeping University. Completed at 4 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by Linkoeping University · Not applicable, Interventional, and Supportive care
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.
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.
990 studies on the registry are indexed under Chronic Disease; 179 are open to participants now.
This study's enrollment of 311 is above the median of 120 across 722 interventional studies indexed under Chronic Disease.
Browse Chronic Disease studies →Linkoeping University is the lead sponsor of 189 studies on the registry; 40 are open to participants now.
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Exclusion Criteria:
Intervention 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
Behavioral: Tele-yoga
The 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.
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.
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.
Time frame: 3 months
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
Time frame: 3 and 6 months
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.
Time frame: 3 and 6 months
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'.
Time frame: 3 and 6 months
Physical activity
Actigraph
Time frame: 3 and 6 months
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.
Time frame: 3 and 6 months
Sleep
Minimal insomnia symptom scale is a sleep questionnaire with 3 items that generates ordinal data. Range 0-12.
Time frame: 3 and 6 months
Exercise Motivation
The Exercise Motivation Index includes 15 items that generates ordinal data on the motives of participating in physical exercise. Range 0-60.
Time frame: 3 and 6 months
Lower body strength
Sit to stand test measure the number of uprising from a chair during 30 seconds.
Time frame: 3 and 6 months
Gait speed
Gait speed test meaures the time it takes in seconds to walk 10 meter at self-selected pace.
Time frame: 3 and 6 months
Health Health
One general health question from RAND 36 genreating an ordinal data response from 1 (poor health)-5 (excellent health).
Time frame: 3 and 6 months
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.
Time frame: 3 and 6 months
HcCRP
High sensitivity C-reactive protein (CRP) will be used as a routine marker of inflammation. Blood samples were collected while the patients were at rest in a supine position using EDTA-vials. The vials were chilled on ice before centrifugation at 3000 g, 4oC and then frozen at -70ºC. No sample was thawed more than twice. CRP was analysed using latex-enhanced turbidimetric immunoassay (Roche Diagnostics GmbH, Vienna, Austria) with a lower detection limit of 0.03 mg/L and coefficient of variation of 1.7%.
Time frame: 3 and 6 months
Cost-effectiveness
Health care utilisation through medical charts/registries. The cost of the intervention will also be calculated.
Time frame: 6 months
Adherence
The adherence will be measured through attendance in video groups and the use of yoga app The minutes each participant have used to perform individual yoga training will be measured via a statistical software incorporated in the yoga app.
Time frame: 3 months
Qualitative interviews
Telephone interviews about yoga, tele-yoga, user-friendliness and use of technology in the tele-yoga group
Time frame: 3 months
Quality-adjusted life-year (QALY)
Will be obtained from the EQ-5D
Time frame: 6 months
Plan to share: No
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Linkoeping University