NCT06532864

Brief Summary

The purpose of this study was to investigate whether 12 weeks of practicing Mawangdui Guiding Technique has an improvement effect on subjective sleep quality, objective sleep quality, and daytime fatigue in older adults in a healthcare hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2024

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2024

Completed
Last Updated

October 1, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

July 29, 2024

Last Update Submit

September 28, 2024

Conditions

Keywords

sleep qualityolder adults

Outcome Measures

Primary Outcomes (4)

  • Pittsburgh Sleep Quality Index

    The Pittsburgh Sleep Quality Index is a comprehensive sleep self-assessment tool containing 19 items. The overall total score ranges from 0-21, with the lower the overall score, the higher the quality of sleep.

    baseline; 4 weeks; 12weeks

  • Insomnia Severity Index

    The Insomnia Severity Index(ISI) is a self-assessment tool consisting of seven items designed to assess various aspects of insomnia. Cumulative ISI scores range from 0 to 28 and are categorized as follows: 0-7 = no insomnia; 8-14 = mild insomnia; 15-21 = moderate insomnia; and 22-28 = severe insomnia.

    baseline; 4 weeks; 12weeks

  • Polysomnography

    Polysomnography is the internationally recognized gold standard for diagnosing sleep disorder disorders and can provide an objective basis for the diagnosis, classification and identification of sleep disorders.

    baseline; 4 weeks; 12weeks

  • Flinders Fatigue Scale

    The Flinders Fatigue Scale is a 7-item scale that measures various characteristics of fatigue. Total fatigue scores range from 0 to 31, with higher scores indicating more severe fatigue.

    baseline; 4 weeks; 12weeks

Study Arms (2)

Practicing Mawangdui Guidance Exersize Group

EXPERIMENTAL

The experimental group underwent the Mawangdui Guided Exercise, which consisted of five 45-minute sessions per week for 12 weeks.

Behavioral: Practice Mawangdui Guiding Technique

Sleep Education Group

NO INTERVENTION

The control group maintained routine sleep education in addition to daily activities.

Interventions

Nursing staff with experience in teaching Mawangdui Daoyin Exercise conducted the operation instruction on different floors. A feasibility assessment of the older adults was carried out by the nursing staff at the end of the teaching, and only after passing this assessment could the experimental part begin. The treatment group participated in five Mawangdui Daoyin Exercise sessions per week, each lasting approximately 45 minutes, and the exercises continued for 12 weeks.

Practicing Mawangdui Guidance Exersize Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged sixty years and above; continuous residence in the participating healthcare hospitals for more than six months
  • Conscious, with basic visual and auditory perception, communication, and cognitive functioning
  • Voluntary enrollment in this study and signing of the informed consent form.

You may not qualify if:

  • Individuals who have suffered a sudden accident, emergency surgery, or a rapid deterioration of a long-term medical condition
  • Individuals who have recently been involved in other rehabilitation activities and who play sports on a regular basis
  • Individuals who are unable to participate in physical activity (e.g., patients suffering from major diseases of the liver, kidneys, heart, brain, or blood system)
  • Individuals suffering from deep venous thrombosis; individuals with musculoskeletal problems with signs of limitation of movement (e.g., unsettled broken bones, pelvic fractures)
  • Individuals with preexisting psychiatric conditions (such as personality disorders, psychosis, and so on); and individuals with symptoms of severe depression.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthcare Hospital

Changsha, Hunan, 410000, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The investigator of the statistical analysis was unaware of the grouping of the subjects
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to experimental and control groups. The experimental group performed Mawangdui Guided Technique exercises, which consisted of five 45-minute sessions per week for 12 weeks. The control group maintained a routine of sleep education in addition to their daily activities.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
teacher

Study Record Dates

First Submitted

July 29, 2024

First Posted

August 1, 2024

Study Start

June 1, 2024

Primary Completion

August 15, 2024

Study Completion

August 20, 2024

Last Updated

October 1, 2024

Record last verified: 2024-07

Locations