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Qigong for Pre-frail and Frail Older Cancer Survivors

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04694066
Enrollment
28
Registered
2021-01-05
Start date
2019-08-01
Completion date
2021-06-30
Last updated
2022-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Frailty

Keywords

Frailty, Cancer survivors, Qigong, Feasibility

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALQigong

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.

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.

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

The care providers, though cannot be blinded, will not have knowledge about the aims of the study. The research assistants responsible for assessing the outcomes and entering the data will be blinded to the group. allocation.

Eligibility

Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

1. aged ≥65 2. diagnosed with stage I-III non-metastatic cancer 3. 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 4. classified as pre-frail or frail based on Fried frailty criteria 5. can communicate in Cantonese or Putonghua 6. written informed consent

Exclusion criteria

1. regular qigong training or other mind body intervention (once or more per week) within the previous 6 months 2. medical conditions affecting mobility, predisposing to falls, or precluding qigong practice (e.g., neurological disease, musculoskeletal disorder, recent myocardial infarction, breathing difficulties requiring oxygen)

Design outcomes

Primary

MeasureTime frameDescription
Feasibility: Study completion rate16 weeksThe proportion of participants who completed the data collection among those randomized will be recorded at each time point.
Feasibility: Attendance rate16 weeksParticipants' attendance to the supervised sessions will be recorded at each time point.

Secondary

MeasureTime frameDescription
Change in Short-Form Geriatric Depression Scale scoresstudy entry, 8 weeks, 16 weeksThe 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.
Change in frailty statusstudy entry, 8 weeks, 16 weeksParticipants' frailty status will be assessed using the Fried frailty criteria, which consists of 5 criteria: slowness , weakness , unintentional weight loss , exhaustion and low activity.
Change in Modified Barthel Index scoresstudy entry, 8 weeks, 16 weeksThe 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).
Change in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire-C30 scoresstudy entry, 8 weeks, 16 weeksEuropean 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.
Change in Short Physical Performance Battery scoresstudy entry, 8 weeks, 16 weeksShort Physical Performance Battery is an objective assessment tool used to measure the physical performance of participants in three functional tasks.

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026