Sleep DisordersNCT07061158
A Multidimensional Health Perspective: Analysis of the Effects of Yoga Intervention on Sleep Disorders in Older Adults
A study testing Structured Yoga Course Intervention in people with Sleep Disorders and Insomnia, run by Beijing Sport University at 1 site in China.
Trial summary
This randomized controlled trial aims to evaluate the impact of a structured yoga intervention on multidimensional health outcomes in older adults with sleep disturbances. A total of 62 participants aged 60 years and older with varying degrees of sleep disorders were recruited and randomly assigned to either a yoga… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sleep Disorders, Insomnia, Aging
- What is being tested?
- Structured Yoga Course Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteChina
- Study dates
- 2 Sep 2024to 1 Apr 2025
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 60 years, conforming to the World Health Organization's definition of the elderly population.
- Presence of varying degrees of sleep disorder symptoms (e.g., difficulty falling asleep, sleep maintenance difficulties, early morning awakening), but without severe mental illness or other significant underlying diseases affecting sleep (e.g., dementia, severe depression).
- Possessing basic comprehension abilities, voluntarily participating in the study, and signing informed consent.
- Capable of cooperating with follow-up and intervention.
- No severe physical dysfunction, cardiopulmonary disease, or other conditions limiting participation in light physical activities (such as yoga practice).
Who cannot join
- Severe mental disorders, such as schizophrenia, bipolar disorder, or severe depression.
- Severe cognitive impairment, making it impossible to cooperate with the intervention and subjective questionnaire assessments.
- Unstable cardiovascular diseases or other major organic diseases (e.g., recent myocardial infarction, end-stage renal failure).
- Severe visual or auditory impairments that affect the safety and adherence to practice.
Trial locations and contacts
1 site in 1 country.
About this study
This randomized controlled trial aims to evaluate the impact of a structured yoga intervention on multidimensional health outcomes in older adults with sleep disturbances. A total of 62 participants aged 60 years and older with varying degrees of sleep disorders were recruited and randomly assigned to either a yoga intervention group or a control group. The intervention group received a standardized yoga program for 4 months, conducted twice weekly (60 minutes per session), and guided by certified instructors. The yoga intervention included physical postures, breathing exercises, and meditation/relaxation techniques. Health outcomes were assessed at baseline, mid-intervention (8 weeks), and post-intervention (16 weeks), across five domains: sleep quality, daytime functioning, cognitive performance, physical fitness, and emotional well-being. This study aims to explore the feasibility, safety, and integrative effects of yoga as a non-pharmacological intervention for promoting health in the aging population.
- Conditions
- Sleep Disorders, Insomnia, Aging, Yoga
- Being tested
- Structured Yoga Course Intervention
- Keywords
- Yoga therapy, Older adults, Non-pharmacological intervention, Sleep quality, Multidimensional health, RCT
- Medical subject headings
- Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Yoga Course InterventionBehavioural
Participants in this arm received a structured yoga course intervention for a period of 4 months. Sessions were held twice weekly, with each lasting 60 minutes. The curriculum was specifically designed to be gentle, slow-paced, and low-impact, making it suitable for older adults while emphasizing body awareness, mind-body integration, and psychological regulation. The course content included: breathing exercises (e.g., basic abdominal breathing combined with simple movements), asana (posture) practice (e.g., seated chair exercises, standing poses, prone poses, supine poses, and side-lying poses, emphasizing muscle activation, joint flexibility, body balance training, and coordination of breath with movement), and meditation and relaxation (e.g., supine rest, moon breath training, and OM chanting). All classes were instructed by experienced yoga teachers certified by the Yoga Alliance.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Intervention Group | Experimental | Participants in this arm received a structured, age-appropriate yoga intervention for a period of 4 months. The program, delivered by certified yoga teachers, integrated physical postures, breathing exercises, and meditation/relaxation techniques designed to improve overall well-being. Receives: Behavioral: Structured Yoga Course Intervention |
| Usual Lifestyle Group | No intervention | Participants in this arm maintained their usual lifestyle during the study period. They did not receive the yoga intervention from this study and only received routine health lifestyle guidance and follow-up. No form of exercise or psychological intervention was conducted during the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is an internationally recognized self-rated questionnaire used to assess subjective sleep quality. A higher total score indicates poorer sleep quality. It encompasses seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. This study assesses changes in the PSQI total score to determine the impact of yoga intervention on the overall sleep status of older adults with sleep disorders.
Measured: Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention
Secondary outcomes (6)
Epworth Sleepiness Scale (ESS)
The Epworth Sleepiness Scale (ESS) primarily assesses the likelihood of a participant experiencing sleepiness in various daily situations, serving as a common tool to measure daytime alertness. Higher scores indicate greater levels of sleepiness.
Measured: Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention
Fatigue Scale-14 (FSS-14)
The Fatigue Scale-14 (FSS-14) assesses the subjective feeling of fatigue in daily life, reflecting the degree of exhaustion caused by sleep disorders. Higher scores indicate greater fatigue.
Measured: Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention
Montreal Cognitive Assessment-Beijing Version (MoCA-BJ)
The Montreal Cognitive Assessment-Beijing Version (MoCA-BJ) is a widely used cognitive screening tool for older adults, covering multiple cognitive domains such as memory, attention, language, visuospatial ability, calculation, and orientation
Measured: Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention
Lower Limb Major Muscle Group Strength (Quadriceps Femoris, Hamstrings, Triceps Surae, Tibialis Anterior, Iliopsoas)
Assesses the strength of major lower limb muscle groups, including the quadriceps femoris, hamstrings, triceps surae, tibialis anterior, and iliopsoas. Maximum isometric contraction values for both sides are recorded using a MICROFET2 standardized electronic dynamometer to comprehensively reflect individual lower limb support and gait stability.
Measured: Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention
Geriatric Depression Scale-15 (GDS-15)
The Geriatric Depression Scale-15 (GDS-15) is suitable for rapid screening of depressive symptoms in older adults. Higher scores indicate a greater tendency towards depression.
Measured: Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention
Self-Rating Anxiety Scale (SAS)
The Self-Rating Anxiety Scale (SAS) is used to assess subjective anxiety levels. Higher scores indicate greater anxiety.
Measured: Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start2 Sep 2024
- Primary completion15 Jan 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061158
- Sponsor's protocol ID
- Yoga intervention
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multidimensional Health Perspective: Analysis of the Effects of Yoga Intervention on Sleep Disorders in Older Adults
- ClinicalTrials.gov ID
- NCT07061158
- Acronym / sponsor ID
- Yoga intervention
- Conditions
- Sleep Disorders, Insomnia, Aging, Yoga
- Keywords
- Yoga therapy, Older adults, Non-pharmacological intervention, Sleep quality, Multidimensional health, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Beijing Sport UniversityUniversity, hospital or other
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial aims to evaluate the impact of a structured yoga intervention on multidimensional health outcomes in older adults with sleep disturbances. A total of 62 participants aged 60 years and older with varying degrees of sleep disorders were recruited and randomly assigned to either a yoga intervention group or a control group. The intervention group received a standardized yoga program for 4 months, conducted twice weekly (60 minutes per session), and guided by certified instructors. The yoga intervention included physical postures, breathing exercises, and meditation/relaxation techniques. Health outcomes were assessed at baseline, mid-intervention (8 weeks), and post-intervention (16 weeks), across five domains: sleep quality, daytime functioning, cognitive performance, physical fitness, and emotional well-being. This study aims to explore the feasibility, safety, and integrative effects of yoga as a non-pharmacological intervention for promoting health in the aging population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga Intervention Group | Experimental | Behavioral: Structured Yoga Course InterventionParticipants in this arm received a structured, age-appropriate yoga intervention for a period of 4 months. The program, delivered by certified yoga teachers, integrated physical postures, breathing exercises, and meditation/relaxation techniques designed to improve overall well-being. |
| Usual Lifestyle Group | No intervention | –Participants in this arm maintained their usual lifestyle during the study period. They did not receive the yoga intervention from this study and only received routine health lifestyle guidance and follow-up. No form of exercise or psychological intervention was conducted during the study. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 60 years, conforming to the World Health Organization's definition of the elderly population.
- Presence of varying degrees of sleep disorder symptoms (e.g., difficulty falling asleep, sleep maintenance difficulties, early morning awakening), but without severe mental illness or other significant underlying diseases affecting sleep (e.g., dementia, severe depression).
- Possessing basic comprehension abilities, voluntarily participating in the study, and signing informed consent.
- Capable of cooperating with follow-up and intervention.
- No severe physical dysfunction, cardiopulmonary disease, or other conditions limiting participation in light physical activities (such as yoga practice).
Key exclusion criteria (4 listed)
- Severe mental disorders, such as schizophrenia, bipolar disorder, or severe depression.
- Severe cognitive impairment, making it impossible to cooperate with the intervention and subjective questionnaire assessments.
- Unstable cardiovascular diseases or other major organic diseases (e.g., recent myocardial infarction, end-stage renal failure).
- Severe visual or auditory impairments that affect the safety and adherence to practice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Yoga Course InterventionParticipants in this arm received a structured yoga course intervention for a period of 4 months. Sessions were held twice weekly, with each lasting 60 minutes. The curriculum was specifically designed to be gentle, slow-paced, and low-impact, making it suitable for older adults while emphasizing body awareness, mind-body integration, and psychological regulation. The course content included: breathing exercises (e.g., basic abdominal breathing combined with simple movements), asana (posture) practice (e.g., seated chair exercises, standing poses, prone poses, supine poses, and side-lying poses, emphasizing muscle activation, joint flexibility, body balance training, and coordination of breath with movement), and meditation and relaxation (e.g., supine rest, moon breath training, and OM chanting). All classes were instructed by experienced yoga teachers certified by the Yoga Alliance. | Behavioural | Yoga Intervention Group |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention
The Pittsburgh Sleep Quality Index (PSQI) is an internationally recognized self-rated questionnaire used to assess subjective sleep quality. A higher total score indicates poorer sleep quality. It encompasses seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. This study assesses changes in the PSQI total score to determine the impact of yoga intervention on the overall sleep status of older adults with sleep disorders.
6 secondary outcomes
Epworth Sleepiness Scale (ESS)
Time frame: Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention
Fatigue Scale-14 (FSS-14)
Time frame: Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention
Montreal Cognitive Assessment-Beijing Version (MoCA-BJ)
Time frame: Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention
Lower Limb Major Muscle Group Strength (Quadriceps Femoris, Hamstrings, Triceps Surae, Tibialis Anterior, Iliopsoas)
Time frame: Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention
Geriatric Depression Scale-15 (GDS-15)
Time frame: Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention
Self-Rating Anxiety Scale (SAS)
Time frame: Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Yoga Course Intervention in people with Sleep Disorders and Insomnia, run by Beijing Sport University at 1 site in China.
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 5 inclusion and 4 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 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Pittsburgh Sleep Quality Index (PSQI) (time frame: Baseline, 2 Months Post-Intervention, and 4 Months Post-Intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2025.