Qigong for Pre-frail and Frail Older Cancer Survivors

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04694066
• Other study ID #: HKUCTR-2708
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: November 2022
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 30, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cancer
• Frailty

Intervention

Behavioral:
• Qigong
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
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.

Locations

Country	Name	City	State
Hong Kong	Pamela Youde Nethersole Eastern Hospital	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: Study completion rate	The proportion of participants who completed the data collection among those randomized will be recorded at each time point.	16 weeks
Primary	Feasibility: Attendance rate	Participants' attendance to the supervised sessions will be recorded at each time point.	16 weeks
Secondary	Change in frailty status	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.	study entry, 8 weeks, 16 weeks
Secondary	Change in Short Physical Performance Battery scores	Short Physical Performance Battery is an objective assessment tool used to measure the physical performance of participants in three functional tasks.	study entry, 8 weeks, 16 weeks
Secondary	Change in Short-Form Geriatric Depression Scale scores	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.	study entry, 8 weeks, 16 weeks
Secondary	Change in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire-C30 scores	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.	study entry, 8 weeks, 16 weeks
Secondary	Change in Modified Barthel Index scores	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).	study entry, 8 weeks, 16 weeks