NCT06943638

Brief Summary

Cancer is one of the main causes of death, and this study looks at how light exercise and stretching might reduce anxiety in patients receiving chemotherapy. The research took place in a hospital's daily care unit and used a study design where each patient was compared to themselves, measuring anxiety before and after the exercise program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 24, 2025

Completed
3 months until next milestone

Results Posted

Study results publicly available

August 1, 2025

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

March 24, 2025

Results QC Date

May 22, 2025

Last Update Submit

July 31, 2025

Conditions

Keywords

cancerphysiotherapyexercisephysical therapychemotherapystress

Outcome Measures

Primary Outcomes (1)

  • The Change in the Anxiety Assessment Scale (STAI-State) for Cancer Patients Receiving Chemotherapy Doing Mild Exercises and Stretches

    The STAI-State (Greek version, State-Trait Anxiety Inventory -STAI-) will be used to assess anxiety levels in cancer patients undergoing chemotherapy, before and after a brief exercise intervention. The STAI-State scale has a 20-item questionnaire where individuals rate how they feel at a particular moment on a scale from "not at all" to "very much so." "Not at all" equal to 1, "Somewhat" to 2, "Moderately so" to 3, "Very much so" to 4. Scores are submitted and range from 20 to 80, with higher scores indicating greater anxiety. No subscale is required to compute At baseline (Time = 0 minutes), participants complete the STAI-State scale. They then engage in a 15-minute mild exercise and stretching program tailored to their physical condition. In some cases, particularly among younger participants, the session may be conducted in small groups of up to 2 individuals. Immediately post-intervention (approximately 20 minutes from baseline), participants complete the STAI-State scale again.

    Baseline and approximately 20 minutes post-intervention

Study Arms (1)

Mild exercise and stretching

EXPERIMENTAL

They received individualized workout and stretching programme to relieve some of the stress

Other: Mild Exercise and stretches

Interventions

For 15 minutes the patient received an individualized mild workout program intending to relax and relieve some of his stress. The workout includes deep breaths, easy-to-do exercises, and stretches from lying on the bed, sitting in a chair, or standing. I always followed the patient's tempo and provided him with as many breaks as he needed.

Mild exercise and stretching

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (\>18 years old) with cancer receiving chemotherapy
  • Signed patient consent

You may not qualify if:

  • The denial of the patient
  • The occurrence of side effects from the treatment (such as dizziness, nausea, severe fatigue)
  • Patients with low cognitive level where they could not follow simple instructions
  • Patients with hearing disorders that prevented them from following simple instructions
  • Patients who could not mobilize independently.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Oncological Hospital of Kifisia Oi Agioi Anargyroi

Athens, Kifissia, 14564, Greece

Location

Related Publications (2)

  • Furmaniak AC, Menig M, Markes MH. Exercise for women receiving adjuvant therapy for breast cancer. Cochrane Database Syst Rev. 2016 Sep 21;9(9):CD005001. doi: 10.1002/14651858.CD005001.pub3.

    PMID: 27650122BACKGROUND
  • Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von Gruenigen VE, Schwartz AL; American College of Sports Medicine. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010 Jul;42(7):1409-26. doi: 10.1249/MSS.0b013e3181e0c112.

    PMID: 20559064BACKGROUND

MeSH Terms

Conditions

NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

The small sample size (n=45) limits generalizability. All participants came from one hospital's Day Care Unit in northern Athens, introducing selection bias. The single 20-minute session and no follow-up restrict conclusions on long-term effects. Including various cancer types without stratified analysis adds heterogeneity. No control group and reliance on self-reports may bias results. Many declined participation due to fatigue or unfamiliarity with exercise.

Results Point of Contact

Title
Christine Mavrogiannopoulou, Physiotherapist and Study coordinator
Organization
General Oncology Hospital of Kifissia "Agioi Anargyroi"

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Researcher

Study Record Dates

First Submitted

March 24, 2025

First Posted

April 24, 2025

Study Start

December 2, 2024

Primary Completion

March 24, 2025

Study Completion

March 24, 2025

Last Updated

August 1, 2025

Results First Posted

August 1, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

IPD will not be shared because this research doesn't require the reproduction of special types of patients. They need to have cancer, receive chemotherapy, and be adults.

Locations