Qigong for Pre-frail and Frail Older Cancer Survivors

NCT04694066 | Completed

• 1 other identifier: HKUCTR-2708
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer; Frailty

Keywords

Frailty; Cancer survivors; Qigong; Feasibility

Outcome Measures

Primary Outcomes (2)

• 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

• Feasibility: Attendance rate

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

  16 weeks

Secondary Outcomes (5)

• Change in frailty status

  study entry, 8 weeks, 16 weeks

• Change in Short Physical Performance Battery scores

  study entry, 8 weeks, 16 weeks

• Change in Short-Form Geriatric Depression Scale scores

  study entry, 8 weeks, 16 weeks

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

  study entry, 8 weeks, 16 weeks

• Change in Modified Barthel Index scores

  study entry, 8 weeks, 16 weeks

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 (followup; 8 hours). The sessions will be supervised by an experienced qigong master.

Behavioral: Qigong

Light flexibility exercise

ACTIVE COMPARATOR

The control group will practice light flexibility exercise only, with the same duration and frequency of supervised sessions identical to the qigong sessions. The supervised sessions will be conducted by a certified exercise trainer.

Behavioral: Light flexibility exercise

Interventions

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.

Qigong

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.

Light flexibility exercise

Eligibility Criteria

• Age: 65 Years - 85 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

Related Publications (1)

• Cheung DST, Chau PH, Lam TC, Ng AYM, Kwok TWH, Takemura N, Woo J, Yu DS, Lin CC. A pilot randomized controlled trial using Baduanjin qigong to reverse frailty status among post-treatment older cancer survivors. J Geriatr Oncol. 2022 Jun;13(5):682-690. doi: 10.1016/j.jgo.2022.02.014. Epub 2022 Mar 7.

  PMID: 35272982 DERIVED

MeSH Terms

Conditions

Neoplasms; Frailty

Interventions

Qigong

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Breathing Exercises; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Denise Cheung

  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: 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.
• 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: January 5, 2021
• Study Start: August 1, 2019
• Primary Completion: February 28, 2021
• Study Completion: June 30, 2021
• Last Updated: November 22, 2022

Record last verified: 2022-11

Locations

HK (2)