Effectiveness of Aquatic Exercise on Fatigue, Neuropathy and Quality of Life Among Cancer Patients

NCT05427344 | Withdrawn

• 1 other identifier: Michal Nissim 2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The majority of cancer patients experience exhaustion, fatigue, and neuropathy that impact their participation in daily activities and reduce their quality of life. In addition, they may affect the ability to function at work and delay a return to employment. Studies have demonstrated that physical activity has a positive effect and consequently, patients being treated for cancer are advised to avoid inactivity. Various studies have described Tai Chi practice as beneficial in reducing exhaustion and fatigue to some extent, and have suggested that it may improve the quality of life of cancer patients. The environment in which physical activity takes place is also important. The properties of water and their effect on the submerged human body may be particularly beneficial for cancer patients. A previous study among breast cancer patients reported that exercise in deep water significantly reduced exhaustion and fatigue compared to patients who received only regular treatment. The practice of Tai Chi in water is termed Ai Chi. The objectives of the present study are to examine the effects of an Ai Chi program as compared to an intervention group undergoing identical physical exercise on land, and a third group with no additional exercise in cancer patients on:(A)time to return to work, work hours, perception of work-related difficulties, and work absenteeism;(B)activity and participation in the daily life and quality of life; and(C)exhaustion, fatigue, and neuropathy. This is a randomized clinical trial. 150 cancer patients aged 18-65 years will be recruited. Subjects who meet the recruitment criteria will be randomly divided into one of three groups:(a)Water exercise (Ai Chi);(b)Identical land exercise; and(c)Control-who will not perform additional physical activity or receive any extra treatments. The exercise program will be scheduled for 30 minutes twice a week for 8 weeks. Research tools include:(1)WHODAS 2.0;(2)EORTC QLQ-C30; (3)Piper Fatigue Scale;(4) Employment Barriers Questionnaire;(5) Neuropathy Questionnaire (EORTCOLO QLQ-CIPN20);and(6)Date of return to work and duration of working hours - self-report by the study participants. Data will be collected before the intervention, after 8 weeks of intervention, and then at 3, 12, and 24 months from the end of the intervention. The investigators will perform a series of mixed variance analyzes to identify relationships and associations between groups and with time within a group (independent variables).

Conditions

Colon Cancer; Breast Cancer

Outcome Measures

Primary Outcomes (24)

• Changes in degree of activity and participation before the start of the intervention (at baseline) and 8 weeks of intervention

  WHODAS 2.0 is a self-report questionnaire that captures the level of functioning in six domains of life: Cognition - understanding and communicating, Mobility - moving and getting around, Self-care - attending to one's hygiene, dressing, eating and staying alone, Getting along - interacting with other people, Life activities - domestic responsibilities, leisure, work and school, Participation - joining in community activities, participating in society. The average scores are comparable to the WHODAS 5-point scale, which allows the clinician to think of the individual's disability in terms of none (0-0.49), mild (0.5-1.49), moderate (1.5-2.49), severe (2.5-3.49), or extreme (3.5-4). The average domain score is calculated by dividing the raw domain score by the number of items in the domain. The average general disability score is calculated by dividing the raw overall score by number of items in the measure (36). The scoring method is used for each of the 6 domains

  Data will be collected before the start of the intervention (at baseline) and 8 weeks of intervention

• Changes in degree of activity and participation before the start of the intervention (at baseline) and 3 months from the end of the intervention.

  WHODAS 2.0 is a self-report questionnaire that captures the level of functioning in six domains of life: Cognition - understanding and communicating, Mobility - moving and getting around, Self-care - attending to one's hygiene, dressing, eating and staying alone, Getting along - interacting with other people, Life activities - domestic responsibilities, leisure, work and school, Participation - joining in community activities, participating in society. The average scores are comparable to the WHODAS 5-point scale, which allows the clinician to think of the individual's disability in terms of none (0-0.49), mild (0.5-1.49), moderate (1.5-2.49), severe (2.5-3.49), or extreme (3.5-4). The average domain score is calculated by dividing the raw domain score by the number of items in the domain. The average general disability score is calculated by dividing the raw overall score by number of items in the measure (36). The scoring method is used for each of the 6 domains

  Data will be collected before the start of the intervention (at baseline) and 3 months from the end of the intervention

• Changes in degree of activity and participation, before the start of the intervention (at baseline), and 12 months from the end of the intervention.

  WHODAS 2.0 is a self-report questionnaire that captures the level of functioning in six domains of life: Cognition - understanding and communicating, Mobility - moving and getting around, Self-care - attending to one's hygiene, dressing, eating and staying alone, Getting along - interacting with other people, Life activities - domestic responsibilities, leisure, work and school, Participation - joining in community activities, participating in society. The average scores are comparable to the WHODAS 5-point scale, which allows the clinician to think of the individual's disability in terms of none (0-0.49), mild (0.5-1.49), moderate (1.5-2.49), severe (2.5-3.49), or extreme (3.5-4). The average domain score is calculated by dividing the raw domain score by the number of items in the domain. The average general disability score is calculated by dividing the raw overall score by number of items in the measure (36). The scoring method is used for each of the 6 domains

  Data will be collected before the start of the intervention (at baseline), and 12, months from the end of the intervention.

• Changes in degree of activity and participation before the start of the intervention (at baseline) and 24 months from the end of the intervention.

  WHODAS 2.0 is a self-report questionnaire that captures the level of functioning in six domains of life: Cognition - understanding and communicating, Mobility - moving and getting around, Self-care - attending to one's hygiene, dressing, eating and staying alone, Getting along - interacting with other people, Life activities - domestic responsibilities, leisure, work and school, Participation - joining in community activities, participating in society. The average scores are comparable to the WHODAS 5-point scale, which allows the clinician to think of the individual's disability in terms of none (0-0.49), mild (0.5-1.49), moderate (1.5-2.49), severe (2.5-3.49), or extreme (3.5-4). The average domain score is calculated by dividing the raw domain score by the number of items in the domain. The average general disability score is calculated by dividing the raw overall score by number of items in the measure (36). The scoring method is used for each of the 6 domains

  Data will be collected before the start of the intervention (at baseline) and 24 months from the end of the intervention.

• Changes in Quality of life before the start of the intervention (at baseline) and 8 weeks of intervention

  The EORTC QLQ-C30 has 30 items arranged into nine scales (dimensions) and six single items. The scales are divided into five function scales (physical, role, cognitive, emotional and social functions); three symptom scales (fatigue, pain, nausea or vomiting) and one global health-status/quality of life dimension. The six single items address specific symptoms: dyspnoea, appetite loss, insomnia, constipation, diarrhoea and a question addressing the financial impact of the disease. Each item has four response alternatives: 1) "not at all", 2) "a little" 3) "quite a bit" 4) "very much" except for the global health-status/quality of life scale, which has response options ranging from 1) "very poor" to 7) "excellent".

  Data will be collected before the start of the intervention (at baseline) and 8 weeks of intervention

• Changes in Quality of life before the start of the intervention (at baseline) and 3 months from the end of the intervention

  The EORTC QLQ-C30 has 30 items arranged into nine scales (dimensions) and six single items. The scales are divided into five function scales (physical, role, cognitive, emotional and social functions); three symptom scales (fatigue, pain, nausea or vomiting) and one global health-status/quality of life dimension. The six single items address specific symptoms: dyspnoea, appetite loss, insomnia, constipation, diarrhoea and a question addressing the financial impact of the disease. Each item has four response alternatives: 1) "not at all", 2) "a little" 3) "quite a bit" 4) "very much" except for the global health-status/quality of life scale, which has response options ranging from 1) "very poor" to 7) "excellent".

  Data will be collected before the start of the intervention (at baseline) and 3 months from the end of the intervention

• Changes in Quality of life before the start of the intervention (at baseline) and 12 months from the end of the intervention

  The EORTC QLQ-C30 has 30 items arranged into nine scales (dimensions) and six single items. The scales are divided into five function scales (physical, role, cognitive, emotional and social functions); three symptom scales (fatigue, pain, nausea or vomiting) and one global health-status/quality of life dimension. The six single items address specific symptoms: dyspnoea, appetite loss, insomnia, constipation, diarrhoea and a question addressing the financial impact of the disease. Each item has four response alternatives: 1) "not at all", 2) "a little" 3) "quite a bit" 4) "very much" except for the global health-status/quality of life scale, which has response options ranging from 1) "very poor" to 7) "excellent".

  Data will be collected before the start of the intervention (at baseline), and 12 months from the end of the intervention.

• Changes in Quality of life before the start of the intervention (at baseline) and 24 months from the end of the intervention

  The EORTC QLQ-C30 has 30 items arranged into nine scales (dimensions) and six single items. The scales are divided into five function scales (physical, role, cognitive, emotional and social functions); three symptom scales (fatigue, pain, nausea or vomiting) and one global health-status/quality of life dimension. The six single items address specific symptoms: dyspnoea, appetite loss, insomnia, constipation, diarrhoea and a question addressing the financial impact of the disease. Each item has four response alternatives: 1) "not at all", 2) "a little" 3) "quite a bit" 4) "very much" except for the global health-status/quality of life scale, which has response options ranging from 1) "very poor" to 7) "excellent".

  Data will be collected before the start of the intervention (at baseline), and 24 months from the end of the intervention.

• Changes in Exhaustion and fatigue before the start of the intervention (at baseline) and 8 weeks of intervention

  Piper Fatigue Scale - to assess the levels of exhaustion and fatigue. It consists of 22 numerical items to assess fatigue at the time of the questionnaire. The items are scored on a 0-10 Likert scale and measure the four dimensions of behavioral/severity (six items), affective meaning (five items), sensory (five items), and cognitive/mood (six items). To calculate the subscale score, the scores of the items on the specific subscales are summed and divided by the number of items in the subscale. All item scores are summed and divided by 22 to calculate the total fatigue score, which has a range from 0 to 10, with a high score indicating a high fatigue level.

  Data will be collected before the start of the intervention (at baseline) and 8 weeks of intervention

• Changes in Exhaustion and fatigue before the start of the intervention (at baseline) and 3 months from the end of the intervention.

  Piper Fatigue Scale - to assess the levels of exhaustion and fatigue. It consists of 22 numerical items to assess fatigue at the time of the questionnaire. The items are scored on a 0-10 Likert scale and measure the four dimensions of behavioral/severity (six items), affective meaning (five items), sensory (five items), and cognitive/mood (six items). To calculate the subscale score, the scores of the items on the specific subscales are summed and divided by the number of items in the subscale. All item scores are summed and divided by 22 to calculate the total fatigue score, which has a range from 0 to 10, with a high score indicating a high fatigue level.

  Data will be collected before the start of the intervention (at baseline) and 3 months from the end of the intervention

• Changes in Exhaustion and fatigue before the start of the intervention (at baseline) and 12 months from the end of the intervention.

  Piper Fatigue Scale - to assess the levels of exhaustion and fatigue. It consists of 22 numerical items to assess fatigue at the time of the questionnaire. The items are scored on a 0-10 Likert scale and measure the four dimensions of behavioral/severity (six items), affective meaning (five items), sensory (five items), and cognitive/mood (six items). To calculate the subscale score, the scores of the items on the specific subscales are summed and divided by the number of items in the subscale. All item scores are summed and divided by 22 to calculate the total fatigue score, which has a range from 0 to 10, with a high score indicating a high fatigue level.

  Data will be collected before the start of the intervention (at baseline) and 12 months from the end of the intervention

• Changes in Exhaustion and fatigue before the start of the intervention (at baseline) and 24 months from the end of the intervention.

  Piper Fatigue Scale - to assess the levels of exhaustion and fatigue. It consists of 22 numerical items to assess fatigue at the time of the questionnaire. The items are scored on a 0-10 Likert scale and measure the four dimensions of behavioral/severity (six items), affective meaning (five items), sensory (five items), and cognitive/mood (six items). To calculate the subscale score, the scores of the items on the specific subscales are summed and divided by the number of items in the subscale. All item scores are summed and divided by 22 to calculate the total fatigue score, which has a range from 0 to 10, with a high score indicating a high fatigue level.

  Data will be collected before the start of the intervention (at baseline) and 24 months from the end of the intervention

• Changes in Employment before the start of the intervention (at baseline) and 8 weeks of intervention

  Employment Barriers Questionnaire. It consists of 77 numerical items to assess workers barriers at the time of the questionnaire. The items are scored on a 0-4 Likert scale and measure the two dimensions of environmental and occupational barriers.

  Data will be collected before the start of the intervention (at baseline) and 8 weeks of intervention

• Changes in Employment before the start of the intervention (at baseline) and 3 months from the end of the intervention.

  Employment Barriers Questionnaire. It consists of 77 numerical items to assess workers barriers at the time of the questionnaire. The items are scored on a 0-4 Likert scale and measure the two dimensions of environmental and occupational barriers.

  Data will be collected before the start of the intervention (at baseline) and 3 months from the end of the intervention

• Changes in Employment before the start of the intervention (at baseline) and 12 months from the end of the intervention.

  Employment Barriers Questionnaire. It consists of 77 numerical items to assess workers barriers at the time of the questionnaire. The items are scored on a 0-4 Likert scale and measure the two dimensions of environmental and occupational barriers.

  Data will be collected before the start of the intervention (at baseline) and 12 months from the end of the intervention

• Changes in Employment before the start of the intervention (at baseline) and 24 months from the end of the intervention.

  Employment Barriers Questionnaire. It consists of 77 numerical items to assess workers barriers at the time of the questionnaire. The items are scored on a 0-4 Likert scale and measure the two dimensions of environmental and occupational barriers.

  Data will be collected before the start of the intervention (at baseline) and 24 months from the end of the intervention

• Changes in Neuropathy before the start of the intervention (at baseline) and 8 weeks of intervention

  Neuropathy Questionnaire (EORTCOLO QLQ-CIPN20). This is a 20-item patient self-report CIPN-specific questionnaire that includes three subscales assessing sensory, motor, and autonomic symptoms with each item measured on a 1-4 Likert scale (1 being "not at all" and 4 being "very much"). Items in the sensory subscale inquire about tingling, numbness, and shooting/burning pain separately for (1) fingers and hands as well as (2) toes and feet.

  Data will be collected before the start of the intervention (at baseline) and 8 weeks of intervention

• Changes in Neuropathy before the start of the intervention (at baseline) and 3 months from the end of the intervention.

  Neuropathy Questionnaire (EORTCOLO QLQ-CIPN20). This is a 20-item patient self-report CIPN-specific questionnaire that includes three subscales assessing sensory, motor, and autonomic symptoms with each item measured on a 1-4 Likert scale (1 being "not at all" and 4 being "very much"). Items in the sensory subscale inquire about tingling, numbness, and shooting/burning pain separately for (1) fingers and hands as well as (2) toes and feet.

  Data will be collected before the start of the intervention (at baseline) and 3 months from the end of the intervention

• Changes in Neuropathy before the start of the intervention (at baseline) and 12 months from the end of the intervention.

  Neuropathy Questionnaire (EORTCOLO QLQ-CIPN20). This is a 20-item patient self-report CIPN-specific questionnaire that includes three subscales assessing sensory, motor, and autonomic symptoms with each item measured on a 1-4 Likert scale (1 being "not at all" and 4 being "very much"). Items in the sensory subscale inquire about tingling, numbness, and shooting/burning pain separately for (1) fingers and hands as well as (2) toes and feet.

  Data will be collected before the start of the intervention (at baseline) and 12 months from the end of the intervention

• Changes in Neuropathy before the start of the intervention (at baseline) and 24 months from the end of the intervention.

  Neuropathy Questionnaire (EORTCOLO QLQ-CIPN20). This is a 20-item patient self-report CIPN-specific questionnaire that includes three subscales assessing sensory, motor, and autonomic symptoms with each item measured on a 1-4 Likert scale (1 being "not at all" and 4 being "very much"). Items in the sensory subscale inquire about tingling, numbness, and shooting/burning pain separately for (1) fingers and hands as well as (2) toes and feet.

  Data will be collected before the start of the intervention (at baseline) and 24 months from the end of the intervention

• Changes in duration of working hours before the start of the intervention (at baseline) and 8 weeks of intervention

  Duration of working hours - self-report by the study participants

  Data will be collected before the start of the intervention (at baseline) and 8 weeks of intervention

• Changes in duration of working hours before the start of the intervention (at baseline) and 3 months from the end of the intervention.

  Duration of working hours - self-report by the study participants

  Chang in Employment before the start of the intervention (at baseline) and 3 months from the end of the intervention.

• Changes in duration of working hours before the start of the intervention (at baseline) and 12 months from the end of the intervention.

  Duration of working hours - self-report by the study participants

  Chang in Employment before the start of the intervention (at baseline) and 12 months from the end of the intervention.

• Changes in duration of working hours before the start of the intervention (at baseline) and 24 months from the end of the intervention.

  Duration of working hours - self-report by the study participants

  Chang in Employment before the start of the intervention (at baseline) and 24 months from the end of the intervention.

Study Arms (3)

Water exercise group

EXPERIMENTAL

Water exercise group where the Ai Chi technique was selected as the exercise method of choice. The activity will take place in a hydrotherapy pool approved by the Ministry of Health and will be led by a hydrotherapist who has been trained in Ai Chi

Other: Water exercise group

Land exercise group

EXPERIMENTAL

Land exercise group who will perform the same Ai Chi movements on land in order to standardize the groups. The activity will take place in a hall and will be led by a physiotherapist who has been trained to teach Ai Chi on land

Other: Land exercise group

Control group

EXPERIMENTAL

Control group who will not perform additional physical activity or receive any extra treatments

Other: Control group

Interventions

Water exercise group OTHER

Water exercise group where the Ai Chi technique was selected as the exercise method of choice. The activity will take place in a hydrotherapy pool approved by the Ministry of Health and will be led by a hydrotherapist who has been trained in Ai Chi.

Water exercise group

Land exercise group OTHER

Land exercise group who will perform the same Ai Chi movements on land in order to standardize the groups. The activity will take place in a hall and will be led by a physiotherapist who has been trained to teach Ai Chi on land.

Land exercise group

Control group OTHER

Control group who will not perform additional physical activity or receive any extra treatments.

Control group

Eligibility Criteria

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

You may qualify if:

• Diagnosis of cancer (stage 3 colon cancer patients and breast cancer patients with lymph node involvement). recruitment of colorectal cancer patients and breast cancer patients for the study will be within 3 months of cessation of chemotherapy treatment.
• a score above 26 on the cognitive MOCA test.

You may not qualify if:

• Volunteers with orthopedic disabilities / injuries that in the opinion of the attending physician prevent their participation in physical exercise
• Volunteers engaged in other physical activity on a regular basis

Sponsors & Collaborators

• Tel Aviv University: lead
• Hadassah Medical Organization: collaborator

Study Sites (1)

Hadassa Hospital

Jerusalem, Israel

Location

Related Publications (1)

• Nissim M, Rottenberg Y, Karniel N, Ratzon NZ. Effects of aquatic exercise program versus on-land exercise program on cancer-related fatigue, neuropathy, activity and participation, quality of life, and return to work for cancer patients: study protocol for a randomized controlled trial. BMC Complement Med Ther. 2024 Feb 2;24(1):74. doi: 10.1186/s12906-024-04367-8.

  PMID: 38308248 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms; Breast Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Navah Z Ratzon, Prof

  Tel Aviv University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head School of Health Professions Sackler Faculty of Medicine

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: June 22, 2022
• Study Start: April 1, 2023
• Primary Completion: November 23, 2024
• Study Completion: November 23, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)