Qigong to Improve Frailty Among Older Cancer Survivors

NCT04692233 | Completed

• 1 other identifier: UW19550
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of the study is to examine the effects of a 16-week Baduanjin qigong intervention on frailty, physical performance, psychological well-being, and health-related quality of life (HRQoL) among post-treatment older cancer survivors. This will be a randomized controlled, assessor-blind trial conforming to the CONSORT guidelines. A total of 226 cancer survivors aged over 65 who have completed curative treatment and screened as pre-frail or frail will be recruited and randomized into intervention and control groups. It is expected that upon intervention completion, the intervention group will demonstrate greater reversed frailty status, more improvements in physical performance, better psychological well-being, and enhanced HRQoL compared to the control group. Study instruments will be Fried Phenotype Criteria, Edmonton Frail Scale, Short Physical Performance Battery, Geriatric Depression Scale, European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire, and a background questionnaire. The intervention comprises of 1-hour qigong group training twice a week for 8 weeks, then 1-hour weekly follow-up group practice for 8 weeks and self-practice. The control group participants will attend light flexibility exercise group sessions at the same duration and frequency as the intervention group. Intention-to-treat analysis will be performed.

Conditions

Cancer; Frailty; Survivorship; Elderly

Keywords

Qigong; Baduanjin; Cancer survivors; Frailty

Outcome Measures

Primary Outcomes (1)

• Improvement 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. Patients with no criteria are considered robust, patients with 1 or 2 criteria are considered pre-frail, and patients with ≥3 criteria are considered frail.

  at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention

Secondary Outcomes (4)

• Improvement in frailty scores

  at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention

• Physical performance

  at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention

• Psychological well-being

  at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention

• Health-related quality of life

  at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention

Study Arms (2)

Qigong

EXPERIMENTAL

The entire intervention will last 16 weeks, including 1-hour supervised training sessions twice a week during weeks 1 to 8 (training; 16 hours), and 1-hour supervised weekly follow-up sessions during weeks 9 to 16 (follow-up; 8 hours). The sessions will be supervised by an experienced qigong master. Throughout the intervention period, participants will be asked to self-practice BQ for 30 minutes twice a week from weeks 1 to 8, and then three times a week from weeks 9 to 16 (20 hours).

Behavioral: Qigong Baduanjin

Light flexibility exercise

ACTIVE COMPARATOR

The control group will practice light flexibility exercise without any abdominal breathing and meditation techniques. The duration and frequency of supervised sessions and self-practice will be identical to the qigong sessions. The supervised sessions will be conducted by a certified exercise trainer.

Behavioral: Light flexibility exercise

Interventions

Qigong Baduanjin BEHAVIORAL

Qigong Baduanjin will comprise eight standardized movements. It is practiced as a combination of body movements, breath control, and mindful meditation, which is designed to improve qi function.

Qigong

Light flexibility exercise BEHAVIORAL

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

Light flexibility exercise

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (2)

Queen Mary Hospital

Hong Kong, 000, Hong Kong

Location

Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Neoplasms; Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Denise Shuk Ting Cheung, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: An independent statistician will generate the randomization list using computer and keep a secure copy of the randomization codes assignments. The group assignment will be sealed in separate opaque envelopes and centrally controlled. The BQ master and exercise trainer will not have knowledge about the aims of the study. The RAs responsible for assessing the outcomes and entering the data will be blinded to the group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: December 31, 2020
• Study Start: February 19, 2021
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available for 3 years after the manuscript on main findings is published.

Locations

HK (2)