Effects of Tele-yoga in Long-term Conditions

NCT03703609 | Completed

• 1 other identifier: 2017/225-31
• Study Type: interventional
• Target: 311
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Chronic Disease

Keywords

yoga; rehabilitation; physical activity; quality of life; anxiety; depression

Outcome Measures

Primary Outcomes (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.

  3 months

Secondary Outcomes (11)

• Aerobic capacity/endurance

  3 and 6 months

• Symptoms of Anxiety and Depression

  3 and 6 months

• Health-related quality of life

  3 and 6 months

• Physical activity

  3 and 6 months

• Cognition

  3 and 6 months

Other Outcomes (5)

• HcCRP

  3 and 6 months

• Cost-effectiveness

  6 months

• Adherence

  3 months

Study Arms (2)

Tele-yoga

EXPERIMENTAL

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

Individual physical activty advice

NO INTERVENTION

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.

Interventions

Tele-yoga BEHAVIORAL

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.

Tele-yoga

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (4)

Mälardals hospital

Eskilstuna, Sweden

Location

Ryhov hospital

Jönköping, Sweden

Location

Linköpings University hospital

Linköping, Sweden

Location

Vrinnevi Hospital

Norrköping, Sweden

Location

Related Publications (1)

• 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.

  PMID: 37703082 DERIVED

Related Links

• Study website

MeSH Terms

Conditions

Chronic Disease; Motor Activity; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Mental Disorders; Behavioral Symptoms

Study Officials

• Anna Stromberg, PhD

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Analyst blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 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.

Study Record Dates

• First Submitted: October 7, 2018
• First Posted: October 12, 2018
• Study Start: October 15, 2018
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4)