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Qigong for Breast Cancer Survivors

13 december 2015 uppdaterad av: Shirley S.M. Fong, The University of Hong Kong

Randomised Controlled Trial of Qigong Training Programme to Alleviate Arm Oedema, ¬Reduce Shoulder Impairment, Improve Body Balance and Quality of Life in Community-dwelling Breast Cancer Survivors

Objectives: (1) To investigate the effects of Qigong training on upper limb oedema, circulatory status, shoulder flexibility and muscular strength, body balance, and quality of life (QOL) in community-dwelling breast cancer survivors; and (2) to explore the relationship between the impairment outcomes and QOL outcomes.

Hypothesis: (1) The experimental participants will have less impairment and a better QOL after Qigong training compared with the no-training control group; and (2) the impairment parameters will be related to the QOL indexes in the Qigong participants.

Design and subjects: This will be a prospective, randomised, single-blinded controlled trial. Approximately 60 breast cancer survivors will be randomly assigned to either the Qigong training group (n~30) or control group (n~30).

Intervention: Participants in the Qigong group will receive 18 Forms of Tai Chi Internal Qigong training for 3 months with two supervised 1-hour sessions per week.

Main outcome measures: The primary outcome measures are upper limb circumference, arterial blood flow velocities and resistance index, shoulder joint passive range of motion, muscular strength (peak force) and body balance. The secondary outcome measure is quality of life as measured by the Functional Assessment of Cancer Therapy - Breast scale.

Data analysis: Data will be analysed via repeated-measures analysis of variance followed by post-hoc tests (α = 0.05).

Expected results: The investigators pilot studies produced encouraging results on the efficacy of Qigong exercise in reducing chronic breast cancer-related symptoms in survivors. Therefore, the investigators expect that participants in the Qigong group will have fewer upper limb impairments and a better quality of life after Qigong training. If the results are positive, this Qigong training regime is readily transferrable to clinical practice, and could have positive socioeconomic effects such as reduced healthcare costs.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Förväntat)

60

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Pokfulam, Hong Kong
        • Rekrytering
        • University of Hong Kong

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

Inclusion Criteria:

The inclusion criteria are

  1. history of a breast malignancy of any stage
  2. history of mastectomy or lumpectomy with or without adjuvant chemotherapy or radiotherapy
  3. having completed conventional cancer treatment and medically stable
  4. no known neurological deficits resulting from breast cancer treatment or other neurological disorders
  5. persistent lymphoedema defined as a circumference difference greater than 2 cm at any point between the surgical upper limb and contralateral upper limb13
  6. female aged 18 or above.

Exclusion Criteria:

The exclusion criteria are

  1. presence of major psychiatric, neurological, musculoskeletal, cardiovascular, peripheral vascular or kidney disorder
  2. receiving conventional cancer treatments such as chemotherapy or radiotherapy, medications such as diuretics or traditional Chinese medicine
  3. recurrent cancer or cancer that has spread to another organ
  4. participation in regular physical activity
  5. prior experience of Qigong or Tai Chi
  6. a smoking habit
  7. pregnancy during the study period.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Qigong training group
Participants assigned to the Qigong group will receive Qigong training. The Qigong training programme will be run for 3 months with two supervised 1-hour sessions per week. Participants will learn the 18 Forms of Tai Chi Internal Qigong. The training sessions will be conducted by a qualified Qigong instructor from the Natural Health Qigong Association. Participants in the control group will receive no Qigong training during the study period. They will receive an 18 Forms of Tai Chi Internal Qigong training package after the study.
Participants will learn the 18 Forms of Tai Chi Internal Qigong. Detailed movement and breathing descriptions of the Qigong training protocol can been found in Mak YK. 18 Forms Tai Chi Qigong [in Chinese]. 7th ed. Hong Kong: Wan Li Book Co.; 2012.
Inget ingripande: Control group
Participants in the control group will receive no Qigong training.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in upper limb circumference
Tidsram: Baseline (0 month) and post-intervention (3 months)
Circumference of both arms will be measured using a cloth measuring tape.
Baseline (0 month) and post-intervention (3 months)
Change in arterial resistance and blood flow velocities
Tidsram: Baseline (0 month) and post-intervention (3 months)
A Doppler ultrasound machine will be used to examine the arterial blood flow velocities.
Baseline (0 month) and post-intervention (3 months)
Change in shoulder flexibility
Tidsram: Baseline (0 month) and post-intervention (3 months)
A universal goniometer will be used to measure the passive range of motion (ROM) of bilateral shoulder abduction and horizontal abduction.
Baseline (0 month) and post-intervention (3 months)
Change in shoulder muscular strength
Tidsram: Baseline (0 month) and post-intervention (3 months)
The maximum isometric muscular strength of the shoulder flexor, abductor, internal rotator and external rotator muscles will be measured bilaterally using the Lafayette Manual Muscle Test System.
Baseline (0 month) and post-intervention (3 months)
Change in body balance
Tidsram: Baseline (0 month) and post-intervention (3 months)
Standing balance of the participants will be measured using timed single leg standing test.
Baseline (0 month) and post-intervention (3 months)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in quality of life
Tidsram: Baseline (0 month) and post-intervention (3 months)
Functional Assessment of Cancer Therapy - Breast scale version 4 will be used.
Baseline (0 month) and post-intervention (3 months)

Samarbetspartners och utredare

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2015

Primärt slutförande (Förväntat)

1 maj 2017

Studieregistreringsdatum

Först inskickad

9 april 2015

Först inskickad som uppfyllde QC-kriterierna

14 april 2015

Första postat (Uppskatta)

17 april 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

15 december 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 december 2015

Senast verifierad

1 december 2015

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 201410159001

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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