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Completed

NCT Number: NCT04694066

Qigong for Pre-frail and Frail Older Cancer Survivors

To-date, there is no evidence on qigong's effects for improving well-being of pre-frail and frail older cancer survivors. Our aim is to conduct a pilot study for testing out the feasibility and acceptability of a qigong intervention to the elderly cancer survivors.

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Key information

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamela Youde Nethersole Eastern Hospital, Hong Kong

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About this study

Frailty is an emerging concept in geriatric research and practice. It is defined as a state of increased vulnerability to adverse outcomes including death. A cohort study has found that respondents with cancer were significantly more frail compared to those without cancer. A plausible explanation is both cancer itself and the therapies used to treat it add additional stressors that challenge a patient's physiologic reserve. A systematic review has revealed a high prevalence of frailty and pre-frailty in older cancer patients, with the median estimates of 42% and 43%, respectively. Cancer treatment can hasten survivors' aging process and increase their risk of developing frailty, thus placing cancer survivors at heightened risk of such poor health outcomes as falls, fractures, and disability. This calls for effective interventions that would improve frailty in older cancer survivors.

Qigong, a type of mind-body intervention, is particularly suitable for older adults, as it is implemented without aerobic and musculoskeletal strain. This equipment-free form of exercise is ideal for settings with limited resources, as well as for the frail elderly, because it can be performed at home at any time, reducing such barriers as weather, transportation, and cost. Meta-analysis suggests that Baduanjin is beneficial in the general population in terms of improved quality of life, balance, handgrip strength, and trunk flexibility. To our knowledge, there is no evidence on qigong's effects for improving well-being of pre-frail and frail older cancer survivors. Our aim is therefore to conduct a pilot study for testing out the feasibility and acceptability of a qigong intervention to the elderly cancer survivors.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged ≥65
  • diagnosed with stage I-III non-metastatic cancer
  • completed primary treatment with curative intent (surgery, chemotherapy, and/or radiation therapy) 6 months to 5 years prior to baseline assessments with no recurrence or occurrence of additional cancers
  • classified as pre-frail or frail based on Fried frailty criteria
  • can communicate in Cantonese or Putonghua
  • written informed consent

Exclusion criteria

  • regular qigong training or other mind body intervention (once or more per week) within the previous 6 months
  • medical conditions affecting mobility, predisposing to falls, or precluding qigong practice (e.g., neurological disease, musculoskeletal disorder, recent myocardial infarction, breathing difficulties requiring oxygen)

Treatment and study plan

Qigong

Behavioral

Qigong Baduanjin, comprising eight standardized movements, will be adopted in the study. It is practiced as a combination of body movements, breath control, and mindful meditation.

Light flexibility exercise

Behavioral

The supervised sessions will include seated and standing stretches that target upper (neck, arms, upper back, shoulders, and chest) and lower body (quadriceps, hamstrings, calves, and hips), as well as trunk rotations.

Primary outcomes

  1. Feasibility: Study completion rate

    Time frame: 16 weeks

    The proportion of participants who completed the data collection among those randomized will be recorded at each time point.

  2. Feasibility: Attendance rate

    Time frame: 16 weeks

    Participants' attendance to the supervised sessions will be recorded at each time point.

Secondary outcomes

  1. Change in frailty status

    Time frame: study entry, 8 weeks, 16 weeks

    Participants' frailty status will be assessed using the Fried frailty criteria, which consists of 5 criteria: slowness , weakness , unintentional weight loss , exhaustion and low activity.

  2. Change in Short Physical Performance Battery scores

    Time frame: study entry, 8 weeks, 16 weeks

    Short Physical Performance Battery is an objective assessment tool used to measure the physical performance of participants in three functional tasks.

  3. Change in Short-Form Geriatric Depression Scale scores

    Time frame: study entry, 8 weeks, 16 weeks

    The Short-Form Geriatric Depression Scale (15 items) will be used to measure psychological well-being. Scores range from 0 to 15, with higher scores representing more severe depressive symptoms.

  4. Change in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire-C30 scores

    Time frame: study entry, 8 weeks, 16 weeks

    European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire-C30 (30 items) will be used to assess health-related quality of life specifically in cancer patients. The questionnaire is composed of five functional scales, three symptom scales, a global health status / QoL scale, and six single items. scale. Scores of all subscales and single-item measures range from 0 to 100. Higher scores for functional scales represent higher level of functioning, global health status/quality of life, but higher scores for a symptom scale / item represent a higher level of symptom severity.

  5. Change in Modified Barthel Index scores

    Time frame: study entry, 8 weeks, 16 weeks

    The Modified Barthel Index will be used to measure participants' performance in activities of daily living such as eating, personal hygiene, and bathing, rated on an arbitrary 2- to 4-point scale depending on the amount of assistance needed. Scores range from 0 (an inability to perform) to 15 (total independence).

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Qigong for Pre-frail and Frail Older Cancer Survivors: A Pilot Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 5, 2021
Registry last updated
Nov 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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