NCT06829940

Brief Summary

Post-COVID recovery is associated with reduced functional fitness/capacity, low quality of life, and physical disabilities in those who survived after contracting the disease. The unpleasant symptoms of chronic post-viral/post-COVID syndrome (chronic fatigue perception, variant nonspecific myalgia, bad mood or depression, and insomnia or sleep disturbances) usually magnify the symptoms of already existing previously diagnosed concurrent untreatable chronic disorders , including the idiopathic chronic fatigue (ICF).(Leszczak et al., 2024) Baduanjin exercise training (BET) is one of the Chinese traditional Health-Qigong exercises that not only integrate slow coordinating postures/positions, breathing techniques, musculoskeletal stretching movements/positions, and meditative mind but also plays a strong role concerning health benefits (e.g. musculoskeletal pain-reducing, sleep disturbance-enhancing effects, and fatigue-reducing effects) (Zou et al., 2018).

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

October 9, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

5 months

First QC Date

February 14, 2025

Last Update Submit

February 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pulmonary function: By Spirometry Device:

    • Pulmonary function: By Spirometry Device: it measure ventilatory functions. forced vital capacity (FVC)

    By Spirometry Device: forced vital capacity will be measured at baseline, and it will be measured after twelve weeks again

Secondary Outcomes (10)

  • Pulmonary function: By Spirometry Device:

    By Spirometry Device forced expiratory volume in one second (FEV1) will be measured at baseline, and it will be measured after twelve weeks again

  • Measuring functional capacity: By Six-minute walk test (6MWT)

    Measuring functional capacity: By Six-minute walk test (6MWT)::will be measured at baseline, and it will be measured again after twelve weeks

  • Modified Borg dyspnea scale (MBDS)

    Modified Borg dyspnea scale (MBDS) will be measured at baseline, and it will be measured again after twelve weeks

  • Strength of lower limb muscles By a thirty-second sit-to-stand test

    thirty-second sit-to-stand test will be measured at baseline, and it will be measured again after twelve weeks

  • Endurance of upper limb muscles: by the maximal repetitions of push-ups (MRPU).

    the maximal repetitions of push-ups (MRPU). will be measured at baseline, and it will be measured again after twelve weeks

  • +5 more secondary outcomes

Study Arms (2)

Baduanjin exercise training

EXPERIMENTAL

Each BET session consisted of a 10-minute warm-up and a 10-minute cool-down period \[Xia et al., 2023\]. These were followed by a 40-minute BET segment, which typically involved eight distinct body postures. These postures are based on the "Health Qigong Baduanjin Standard," as outlined in Zhao et al. \[2019\] and Koh \[1982\]. The eight postures are: (1) Support the Heaven, (2) Draw a Bow to Each Side, (3) Hold Up a Single Hand, (4) Practice Looking Back, (5) Shake the Hand and Wag the Tail, (6) Touch the Feet with Both Hands, (7) Climbing with Both Hands, and (8) Relax the Back, as explained in Zeng et al. \[2020\]

Other: Baduanjin exercise training (BET)

waitlist

NO INTERVENTION

this group will receive no intervention

Interventions

Baduanjin Exercise Training (BET) is a traditional Chinese exercise focused on improving physical health, flexibility, balance, and mental well-being. It involves a 10-minute warm-up, a 40-minute core session practicing eight distinct postures, and a 10-minute cool-down. The postures, based on the Baduanjin form, target different body parts and promote strength, flexibility, and circulation. The exercises are synchronized with deep breathing to enhance relaxation and stress reduction. BET is especially beneficial for joint health, mobility, and mental clarity, making it suitable for individuals of all ages and fitness levels

Baduanjin exercise training

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 40 patients will be recruited in the study.
  • age ≥ 18 to ≤ 50 years old
  • achieved three diagnostic items/criteria of ICF will be included in this BET trial: Fatigue lasting over 6 months, which significantly limits daily activities, reducing the person's usual activity level by more than 50%, as confirmed by a doctor.
  • At least three of the following symptoms:
  • Generalized muscle weakness Difficulty sleeping Frequent headaches A painful throat Muscle tenderness throughout the body Migratory joint pain Swollen lymph nodes in the neck or armpits Fatigue lasting more than a day after typical activities

You may not qualify if:

  • Patients with a history of medical or complementary treatments for ICF disorder in the 6 months before contracting COVID or after recovery.
  • Individuals who have engaged in therapeutic exercise, pharmacological treatments, or complementary therapies for post-COVID symptoms within the last six months prior to enrollment.
  • ICF patients regularly using antidepressants or antipsychotics were excluded.
  • Those who take sleeping pills regularly were also excluded.
  • Patients with autoimmune diseases, malignant conditions, anemia, endocrine disorders, systemic diseases, or osteoarthritis affecting the cervical spine, lumbar region, or limbs were excluded.
  • Individuals with abnormal results in laboratory tests, including neurological, neurophysiological, cardiological, liver/kidney function tests, or urine/stool analyses (as determined by a physician) were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 11432, Egypt

RECRUITING

Study Officials

  • Alaa El-moatasem, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaa El-moatasem, lecturer

CONTACT

Rania ali, assistant professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy

Study Record Dates

First Submitted

February 14, 2025

First Posted

February 17, 2025

Study Start

October 9, 2024

Primary Completion

February 22, 2025

Study Completion

March 1, 2025

Last Updated

February 17, 2025

Record last verified: 2025-02

Locations