Effect of a Self-designed MET Exercise Intervention on Cancer-related Fatigue in Patients With Gastric Cancer

NCT05401045 | Completed

• 1 other identifier: RJHK-2020-16
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the effect of using Self-arranged Metabolic Equivalent Exercises on cancer-related fatigue in gastric cancer patients. Gastric cancer patients admitted to the oncology department of a tertiary hospital in Shanghai were selected as study subjects and randomly divided into observation group and control group. The experimental group used Metabolic Equivalent Exercises for intervention besides exercise education and implemented records. In the control group, conventional exercise catharsis was performed. The Piper Revised Fatigue Scale (RPFS) and QLQ-30 Quality of Life Scale were used to measure cancer-caused fatigue and quality of life in both groups at the first admission and after 3 months.

Conditions

Neoplasm of Stomach

Outcome Measures

Primary Outcomes (1)

• Fatigue state using the Revised Piper Fatigue Scale (RPFS)

  Cancer-related fatigue is distressing persistent, subjective sense of physical, emotional and/or cognitive tiredness or exhaustion related to cancer or cancer treatment that is not proportional to recent activity and interferes with usual functioning. To use the Revised Piper Fatigue Scale (RPFS) to investigate the fatigue state.The RPFS includes 22 items and 3 open-ended questions regarding the duration of fatigue, the possible causes of fatigue, fatigue-influencing factors, measures to relieve fatigue, and symptoms related to fatigue\[7\]. The 22 items address the degree that fatigue affects daily activities (6 items), emotional (5 items) and physical (5 items) factors that affect fatigue, and the cognitive and emotional statuses of the respondent (6 items). A number from 0 to 10 is used to indicate the degree of fatigue, with 0 indicating no fatigue and 10 the most severe fatigue; the higher the score is, the more severe the fatigue is.

  up to 3 months

Secondary Outcomes (1)

• Quality of life using the European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC-C30)

  up to 3 months

Study Arms (2)

observation group

EXPERIMENTAL

1. Exercise plan: Each session of the self-designed METexercises were divided into 8 components. There are 4 sets and 8-repetitions per component, taking approximately 4 minutes to complete and consuming approximately 18 calories. Patients were instructed to exercise once in the morning and once in the evening.Metabolic equivalent intensity: The intensity of exercise was expressed as metabolic equivalents (METs). 2. Exercise training: Members of the fatigue management team in the ward taught the patients to perform MET exercises using videos.The fatigue management team members confirmed that the patient could perform the exercise independently and correctly.

Behavioral: Met exercises

control group

NO INTERVENTION

Participants received routine exercise health education that included information pertaining to CRF (causes of CRF, clinical manifestations, related factors, the necessity and importance of fatigue prevention, and measures to improve CRF, etc.) and exercise (3-5 times per week, regardless of the type of exercise). The patients were also informed about the precautions for exercise.

Interventions

Met exercises BEHAVIORAL

Exercise plan: Each session of the self-designed MET exercise program was divided into 8 components: stretching exercises, chest expansion exercises, kicking exercises, lateral movement exercises, body rotation exercises, whole-body exercises, jumping exercises, and a cool down. There are 4 sets and 8-repetitions per component, taking approximately 4 minutes to complete and consuming approximately 18 calories. Patients were instructed to exercise once in the morning and once in the evening. For patients with moderate fatigue and an RPFS score of 4 to 6 points, low-intensity exercise was recommended, i.e., patients could choose 1 to 4 metabolic equivalent exercises and repeat them twice; for patients with mild fatigue and an RPFS score of 1 to 3 points, moderate-intensity exercise was recommended, i.e., patients could choose to complete the entire set of metabolic equivalent exercises or 5 to 8 of the exercises and repeat them twice. The exercise frequency was 5 times per week.

observation group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older;
• Clear pathological diagnosis and staging;
• Undergoing chemotherapy
• CRF based on a total score ≥1 on the revised Piper Fatigue Scale (RPFS) after admission;
• CRF with a Barthel index greater than 80 points;
• Agreed to participate voluntarily and signed an informed consent form;
• Life expectancy of at least 3 months

You may not qualify if:

• Patients with heart, lung, liver, kidney and other vital organ failure;
• Patients with mental disorders and unable to communicate verbally;
• Patients with sudden changes in the disease course.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (20)

• Ruifeng Z. The influencing Factors of Cancer-Related Fatigue in gastric cancer patients in perioperative period[D].Dalian：Dalian Medical School,2017

  BACKGROUND

• Xiaodong X, Xiaoyu Z. Latest progress in cancer-related fatigue: Interpretation of National Comprehensive Cancer Network guidelines for cancer-related fatigue version 1.2018[J]. Chinese Journal of Clinical Oncology, 2018,45(16)

  BACKGROUND

• Mitchell SA, Beck SL, Hood LE, Moore K, Tanner ER. Putting evidence into practice: evidence-based interventions for fatigue during and following cancer and its treatment. Clin J Oncol Nurs. 2007 Feb;11(1):99-113. doi: 10.1188/07.CJON.99-113.

  PMID: 17441401 BACKGROUND

• Lian L, Linhui Z, Mingqin C. Advances in diagnostic and assessment scales for cancer-caused fatigue[J].XinJiang Medicine,2016,46(11):1458-1461,1465

  BACKGROUND

• So WK, Dodgson J, Tai JW. Fatigue and quality of life among Chinese patients with hematologic malignancy after bone marrow transplantation. Cancer Nurs. 2003 Jun;26(3):211-9; quiz 220-1. doi: 10.1097/00002820-200306000-00006.

  PMID: 12832954 BACKGROUND

• Chonghua W, Mingqing C, Canzhen Z et al. The Chinese version of EORTC QLQ-C3 form in evaluation of quality of life for patients with cancer[J].Journal of Practical Oncology,2005,20(4):353-355

  BACKGROUND

• Hojman P, Gehl J, Christensen JF, Pedersen BK. Molecular Mechanisms Linking Exercise to Cancer Prevention and Treatment. Cell Metab. 2018 Jan 9;27(1):10-21. doi: 10.1016/j.cmet.2017.09.015. Epub 2017 Oct 19.

  PMID: 29056514 BACKGROUND

• Kun Y,Min L.Impact of quality nursing service on postoperative rehabilitation of patients with rib fractures combined with pneumothorax[J]. Journal of Clinical Medicine in Practice,2017,21(14):185-186

  BACKGROUND

• Harvey SB, Overland S, Hatch SL, Wessely S, Mykletun A, Hotopf M. Exercise and the Prevention of Depression: Results of the HUNT Cohort Study. Am J Psychiatry. 2018 Jan 1;175(1):28-36. doi: 10.1176/appi.ajp.2017.16111223. Epub 2017 Oct 3.

  PMID: 28969440 BACKGROUND

• Nakano J, Hashizume K, Fukushima T, Ueno K, Matsuura E, Ikio Y, Ishii S, Morishita S, Tanaka K, Kusuba Y. Effects of Aerobic and Resistance Exercises on Physical Symptoms in Cancer Patients: A Meta-analysis. Integr Cancer Ther. 2018 Dec;17(4):1048-1058. doi: 10.1177/1534735418807555. Epub 2018 Oct 23.

  PMID: 30352523 BACKGROUND

• Jensen W, Bialy L, Ketels G, Baumann FT, Bokemeyer C, Oechsle K. Physical exercise and therapy in terminally ill cancer patients: a retrospective feasibility analysis. Support Care Cancer. 2014 May;22(5):1261-8. doi: 10.1007/s00520-013-2080-4. Epub 2013 Dec 7.

  PMID: 24317851 BACKGROUND

• Blaney J, Lowe-Strong A, Rankin J, Campbell A, Allen J, Gracey J. The cancer rehabilitation journey: barriers to and facilitators of exercise among patients with cancer-related fatigue. Phys Ther. 2010 Aug;90(8):1135-47. doi: 10.2522/ptj.20090278. Epub 2010 Jun 17.

  PMID: 20558566 BACKGROUND

• Qiqiong T, Liping G, Ruiping L et al. Physical activity state of cancer - related fatigue patients during malignant tumor chemotherapy period and its influencing factor analysis[J]. Nursing practice and research, 2016,13(13):79-80

  BACKGROUND

• Pearson EJM, Morris ME, McKinstry CE. Cancer related fatigue: implementing guidelines for optimal management. BMC Health Serv Res. 2017 Jul 18;17(1):496. doi: 10.1186/s12913-017-2415-9.

  PMID: 28720109 BACKGROUND

• Ballard-Barbash R, Friedenreich CM, Courneya KS, Siddiqi SM, McTiernan A, Alfano CM. Physical activity, biomarkers, and disease outcomes in cancer survivors: a systematic review. J Natl Cancer Inst. 2012 Jun 6;104(11):815-40. doi: 10.1093/jnci/djs207. Epub 2012 May 8.

  PMID: 22570317 BACKGROUND

• Sasso JP, Eves ND, Christensen JF, Koelwyn GJ, Scott J, Jones LW. A framework for prescription in exercise-oncology research. J Cachexia Sarcopenia Muscle. 2015 Jun;6(2):115-24. doi: 10.1002/jcsm.12042. Epub 2015 May 11.

  PMID: 26136187 BACKGROUND

• Moore SC, Lee IM, Weiderpass E, Campbell PT, Sampson JN, Kitahara CM, Keadle SK, Arem H, Berrington de Gonzalez A, Hartge P, Adami HO, Blair CK, Borch KB, Boyd E, Check DP, Fournier A, Freedman ND, Gunter M, Johannson M, Khaw KT, Linet MS, Orsini N, Park Y, Riboli E, Robien K, Schairer C, Sesso H, Spriggs M, Van Dusen R, Wolk A, Matthews CE, Patel AV. Association of Leisure-Time Physical Activity With Risk of 26 Types of Cancer in 1.44 Million Adults. JAMA Intern Med. 2016 Jun 1;176(6):816-25. doi: 10.1001/jamainternmed.2016.1548.

  PMID: 27183032 BACKGROUND

• Xiao Yue , ZHAO Kun, XUE ming ,et al. Study on the comprehensive goal and index system of Healthy China 2030[J].Health economics research, 2017(4):3-7

  BACKGROUND

• GLOBOCAN 2020. Estimated number of of new cases of new cases in 2020, China, both sex, alll ages. [EB/OB]https://gco.iarc.fr/today

  RESULT

• Guilan L, Halin W, Jing Z et al. Cancer related fatigue in nasopharyngeal carcinoma patients during radiation therapy: nursing intervention[J]. Journal of Nursing Science, 2014, 29(8):44-45

  RESULT

Related Links

• GLOBOCAN 2020

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Lei Huang, PhD, MD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Fellow; PI

Study Record Dates

• First Submitted: May 15, 2022
• First Posted: June 2, 2022
• Study Start: January 20, 2023
• Primary Completion: June 17, 2023
• Study Completion: July 29, 2023
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)