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Neoplasm of StomachSMEENCT05401045

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

A study testing Met exercises in people with Neoplasm of Stomach, run by Ruijin Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Neoplasm of Stomach
What is being tested?
Met exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
119 participants
Where
1 siteChina
Study dates
20 Jan 2023to 29 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Ruijin Hospital

    Shanghai, Shanghai Municipality, 200025

Other trials in China

About this study

Official title: Effect of a Self-designed Metabolic Equivalent Exercise Intervention on Cancer-related Fatigue in Patients With Gastric Cancer

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.

Read the detailed description

This study was a randomized controlled trial. The subjects were randomly assigned into a SMEE or a control group.

For the SMEE group:

  1. The general information questionnaire, RPFS, and the Chinese version of the EORTC QLQ-C30 (V3.0) were used for the baseline assessment of patients, and intervention was performed for patients with an RPFS score greater than or equal to 1.
  2. Exercise plan: Each session of the SMEE 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 cooldown. There were 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 with an RPFS score of 4 to 6 points, low-intensity exercises were recommended, i.e., patients could choose 1 to 4 metabolic equivalent exercises and repeat them twice; for patients with mild fatigue and with an RPFS score of 1 to 3 points, moderate-intensity exercises were 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. Nurses informed the participants of the precautions for exercises to ensure safe implementation. Metabolic equivalent intensity: The intensity of exercises was expressed as metabolic equivalents (METs). For this study, greater than or equal to 6 METs indicated high intensity, 3 to 5.9 METs moderate intensity, and less than 3 METs low intensity.
  3. Exercise training: Members of the Fatigue Management Team in the ward taught the patients to perform metabolic equivalent exercises using videos. Exercise guidance was provided after assessments of surgical, catheter, and incisional pain. Patients could follow the department's WeChat public account to watch complete videos pertaining to metabolic equivalent exercises and related exercise precautions. The Fatigue Management Team members confirmed that a patient could perform the exercise independently and correctly.
  4. Health education: The participants were provided with information related to CRF (causes, clinical manifestations, associated factors, the necessity and importance of fatigue prevention, and measures to reduce CRF, etc.) and exercises (intensity, time, frequency, precautions, etc.)
  5. Recording: Each participant completed a form after each exercise session.
  6. Follow-up: A nurse followed up with each patient by telephone every 2 weeks to determine if the patient completed his or her exercise sessions. Exercise completion rate (%)=(actual exercise time÷planned exercise time)×100%. Nurses supervised and provided reminders to patients with completion rates below 50%. In addition, each patient's exercise success rate was calculated: Exercise success rate (%)=(real-time heart rate after exercise÷target heart rate)×100% (>70% was considered to be up to standard). Target heart rate=(200-age)×100%; a heart rate of 70% to 80% of the target heart rate could improve cardiopulmonary function.

For the control group:

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

After 3 months, the SMEE and the control groups were reassessed using the RPFS and the Chinese version of the EORTC QLQ-C30 (V3.0).

Being tested
Met exercises
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Met exercisesBehavioural

    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.

Study groups in NCT05401045
Study groupRoleWhat they receive
observation groupExperimental1. 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.
Receives: Behavioral: Met exercises
control groupNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 3 months

Secondary outcomes (1)

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

    Quality of life refers to a person's feeling of life, is a concept of comprehensive evaluation of the pros and cons of life, usually refers to a result of the development of social policies and plans, mainly refers to the state assessment of individual physical, psychological and social functions. We use the European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC-C30) to measure. The scale has a total of 30 items that are evaluated in 5 functional areas (physical, role, emotional, cognitive, and social dimensions). The higher the functional field and overall scores are, the higher the quality of life of the respondent is; the higher the symptom field scores are, the worse the quality of life is.

    Measured: up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2022
  2. Study start20 Jan 2023
  3. Primary completion17 Jun 2023
  4. Study completion29 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05401045
Sponsor's protocol ID
RJHK-2020-16
Acronym
SMEE
Status last verified
Dec 2023
First submitted
15 May 2022
Last updated
21 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

  • 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)

  • 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.

    PubMed 17441401

  • 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

  • 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.

    PubMed 12832954

  • 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

  • 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.

    PubMed 29056514

  • 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

  • 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.

    PubMed 28969440

  • 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.

    PubMed 30352523

  • 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.

    PubMed 24317851

  • 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.

    PubMed 20558566

  • 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

  • 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.

    PubMed 28720109

  • 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.

    PubMed 22570317

Questions about this trial

What is this clinical trial studying?

A study testing Met exercises in people with Neoplasm of Stomach, run by Ruijin Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fatigue state using the Revised Piper Fatigue Scale (RPFS) (time frame: up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05401045, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.

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