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

NCT ID: NCT05427344

Last Updated: 2024-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-11-23

Brief Summary

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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).

Detailed Description

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Conditions

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Colon Cancer Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Water exercise group

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

Group Type EXPERIMENTAL

Water exercise group

Intervention Type 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.

Land exercise group

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

Group Type EXPERIMENTAL

Land exercise group

Intervention Type 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.

Control group

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

Group Type EXPERIMENTAL

Control group

Intervention Type OTHER

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

Interventions

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Water exercise group

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.

Intervention Type OTHER

Land exercise group

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.

Intervention Type OTHER

Control group

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role collaborator

Tel Aviv University

OTHER

Sponsor Role lead

Responsible Party

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Navah Ratzon

Head School of Health Professions Sackler Faculty of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Navah Z Ratzon, Prof

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv University

Locations

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Hadassa Hospital

Jerusalem, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 38308248 (View on PubMed)

Other Identifiers

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Michal Nissim 2

Identifier Type: -

Identifier Source: org_study_id

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