Aerobic Exercise and Tai-chi Interventions for Improving Survival in Lung Cancer Patients

NCT03482323 | Completed

• 1 other identifier: UW18154
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This proposed study aims to examine the effect of classical aerobic exercise or tai-chi on 1-year survival rate of lung cancer patients compared to usual care, as a primary outcome of this study. To understand the hypothesized outcomes of improved survival of lung cancer patients through physical exercise or tai-chi practice intervention, we will examine the changes in some subjective psychosocial outcomes and objective biomarkers that may be associated with the survival of cancer patients, as the secondary outcome of this study. Those biomarkers will be in following aspects: 1.) circadian rhythm, 2.) cardio-respiratory fitness, and 3.) immune functions. Secondary outcome measures include: quality of life, psychological distress, quality of sleep, fatigue, level of physical activity, circadian rhythms, cardio-respiratory fitness, physical functioning tests and immune function. The pilot study aims to assess the feasibility and acceptability of the trial so that the main study will have a higher chance of success.

Conditions

Lung Cancer Patients

Outcome Measures

Primary Outcomes (1)

• One-year survival rate

  Duration of survival in participants shall be monitored. For cases of death, causes of death will be collected from patients' clinical dataset to insure data quality. Cancer progress-free survival will be taken at the end of the study period.

  One year

Secondary Outcomes (10)

• Levels of physical activity

  Baseline, 12 weeks, 6 months and one year

• Circadian rhythms- cortisol and melatonin rhythms

  Baseline and one year

• Cardio-respiratory fitness- 6-minute walking test

  Baseline, 12 weeks, 6 months and one year

• Physical functioning- timed up and go test, sit to stand test, single leg standing test, Get Active Questionnaire

  Baseline, 12 weeks, 6 months and one year

• Immune functions- cytotoxic activity of natural killer (NK) cells, and spontaneous or phytohemagglutinin (PHA)-stimulated T-lymphocyte proliferation

  Baseline and one year

Study Arms (3)

Exercise intervention

EXPERIMENTAL

Exercise class will run twice a week for 12 weeks. Participants will be encouraged to maintain their exercise beyond the intervention. An exercise trainer will lead the classes. The main activity of the classes includes aerobic exercises of walking on treadmill, or out-doors depending on group preference and weather, at a set pace individually tailored for moderate intensity of exercise, determined by baseline physical functioning assessment and modified based on Rated Perceived Exertion (RPE), or cycling on a stationary bike, using a set resistance to the physical functioning assessment and RPE. A set of four strengthening exercises are included in one of the exercise classes each week. These exercises are chosen to increase strength in the leg, arm, abdomen and improve trunk stability. Weights for the strengthening exercise will be set to give participants a moderate level of intensity of exercise.

Behavioral: Exercise

Tai-chi intervention

EXPERIMENTAL

The classes will run twice a week for 12 weeks with each session lasting approximately 60 minutes. Classes will be taught by an experienced tai-chi master, who will explain the theory behind tai-chi and the principles of the techniques. The supervised session includes a warm up, self-massage and a guided run through of the movements, breathing techniques, and relaxation in tai-chi. The tai-chi master will guide participants to practice the tai-chi they learn in the classes at home each day. Upon completion of the 12 weeks course, participants will be encouraged to continue their tai-chi practice, given guidance on local services and programmes they may join if they wish to.

Behavioral: Tai-Chi

Control group

NO INTERVENTION

Participants randomised to the control group shall receive written information on health levels of physical activity, which they can participate in at home (self-management) and continue to receive their usual care, participants will be followed up with an assessment at 12 weeks, 6 months and one year. At the end of the evaluation stage of the study, survivors in the control group will be invited to take part in an intervention of their choice.

Interventions

Exercise BEHAVIORAL

Our exercise class intervention is based on current best evidence and will be tailored for each participant's ability for exercise. The exercise classes is also designed to fit into the guidelines for exercise in adults aged 18 years and above with a long term health condition. During the 12 weeks in the training, exercises will be varied (mixing up time spent on bikes and walking) along with the intensities of exercise varied to keep the classes more engaging for participants and maintaining compliance to the programme.

Exercise intervention

Tai-Chi BEHAVIORAL

Our tai-chi classes will be based on a 24-form Yang style of tai-chi exercise set.

Tai-chi intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are diagnosed of stage IIIB, or IV non-small-cell lung cancer confirmed by pathology
• Patients are not currently engaged in other research or participant in any other exercise or mind-body classes
• Patients aged 18 years old, or above
• Patients who can communicate in Cantonese, Mandarin or English
• Patients with no other cancer diagnosis within the previous 1 year
• Patients report not doing regular exercises (defined \<150 min of moderate-intensity exercise weekly) in daily living, but are able to attend either exercise or tai-chi classes at scheduled times
• Patients being conscious and alert.

You may not qualify if:

• Patients suffering from a diagnosed active neurological, substance abuse and /or psychiatric disorders (i.e. depression, chronic insomnia) will be excluded.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (7)

• Fong DY, Ho JW, Hui BP, Lee AM, Macfarlane DJ, Leung SS, Cerin E, Chan WY, Leung IP, Lam SH, Taylor AJ, Cheng KK. Physical activity for cancer survivors: meta-analysis of randomised controlled trials. BMJ. 2012 Jan 30;344:e70. doi: 10.1136/bmj.e70.

  PMID: 22294757 BACKGROUND

• Mustian KM, Katula JA, Gill DL, Roscoe JA, Lang D, Murphy K. Tai Chi Chuan, health-related quality of life and self-esteem: a randomized trial with breast cancer survivors. Support Care Cancer. 2004 Dec;12(12):871-6. doi: 10.1007/s00520-004-0682-6. Epub 2004 Sep 30.

  PMID: 15599776 BACKGROUND

• Sui X, Lee DC, Matthews CE, Adams SA, Hebert JR, Church TS, Lee CD, Blair SN. Influence of cardiorespiratory fitness on lung cancer mortality. Med Sci Sports Exerc. 2010 May;42(5):872-8. doi: 10.1249/MSS.0b013e3181c47b65.

  PMID: 19996990 BACKGROUND

• Chen HM, Tsai CM, Wu YC, Lin KC, Lin CC. Effect of walking on circadian rhythms and sleep quality of patients with lung cancer: a randomised controlled trial. Br J Cancer. 2016 Nov 22;115(11):1304-1312. doi: 10.1038/bjc.2016.356. Epub 2016 Nov 3.

  PMID: 27811855 BACKGROUND

• Chen HM, Tsai CM, Wu YC, Lin KC, Lin CC. Randomised controlled trial on the effectiveness of home-based walking exercise on anxiety, depression and cancer-related symptoms in patients with lung cancer. Br J Cancer. 2015 Feb 3;112(3):438-45. doi: 10.1038/bjc.2014.612. Epub 2014 Dec 9.

  PMID: 25490525 BACKGROUND

• Cheung DST, Takemura N, Lam TC, Ho JCM, Deng W, Smith R, Yan Y, Lee AWM, Lin CC. Feasibility of Aerobic Exercise and Tai-Chi Interventions in Advanced Lung Cancer Patients: A Randomized Controlled Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211033352. doi: 10.1177/15347354211033352.

  PMID: 34549648 DERIVED

• Takemura N, Cheung DST, Fong DYT, Lee AWM, Lam TC, Ho JC, Kam TY, Chik JYK, Lin CC. Relationship of subjective and objective sleep measures with physical performance in advanced-stage lung cancer patients. Sci Rep. 2021 Aug 26;11(1):17208. doi: 10.1038/s41598-021-96481-7.

  PMID: 34446756 DERIVED

MeSH Terms

Interventions

Exercise; Tai Ji

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Chia-Chin Lin, 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: All baseline and follow-up assessments will be carried out by research staff who are blinded to allocation. The statistician and laboratory staff for the measurement of biomarkers remains still blinded until the end of the whole study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of School of Nursing, Alice Ho Miu Ling Nethersole Charity Foundation Professor in Nursing

Model Details: The participants will be randomised into equally sized arms; tai-chi classes, exercise classes, or control.

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: March 29, 2018
• Study Start: May 10, 2018
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: December 24, 2020

Record last verified: 2020-12

Locations

HK (1)