NCT04151238

Brief Summary

Exhausting chemotherapy, adverse effects of chemotherapy and a lack of information on the benefits of physical exercise are the among the reasons for reduced physical exercise among cancer patients during chemotherapy courses. According to best current knowledge only about 10% of cancer patients in Finland are physically active during cancer treatment. In addition, only 20-30% are physically active after recovery from the treatments (Pylkkänen, 2015). There is only little awareness about the benefits of physical activity during cancer treatments. The purpose of the exercise intervention study is to increase the physical activity of patients who are on chemotherapy. The study is a pilot trial and has no control group. Internationally, exercise interventions have been studied among cancer patients on treatment for decades. The American College of Sports Medicine (ACSM) recommends that cancer patients should have 150 minutes of endurance exercise per week and at least two bouts of muscle strength exercise per week. Consequently, the exercise intervention study will have a combination of muscle power and endurance training. To reach the weekly recommended level of exercise, the cancer patients in the study will additionally have a weekly home training program containing preferentially endurance training. A literature search shows that no studies on exercise interventions during cancer treatment have been published in Finland. Thus, this thesis carries the wider implication of increasing the general knowledge on the importance of physical activity of cancer patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Feb 2020

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

First Submitted

Initial submission to the registry

October 14, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

February 17, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2020

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2020

Completed
Last Updated

November 2, 2022

Status Verified

November 1, 2022

Enrollment Period

2 months

First QC Date

October 14, 2019

Last Update Submit

November 1, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • physical activity changes in diary

    Does this exercise intervention model works for cancer patients to increase the amount of physical activity and to achieve the cancer patients exercise recommendations? (especially home-exercising)

    0 and 8 weeks,

  • questionnaire-feedback from cancer patients

    Does this exercise intervention model works for cancer patients to change the amount of physical activity? Patients subjective feedback about the first exercise group model in special health care. The questions are formed in quantitative way.

    0 and 8 weeks

Secondary Outcomes (10)

  • Quality of life questionnaire (EORTC QLQ-c30)

    0 and 8 weeks

  • Fatigue questionnaire (FACIT-F)

    0 and 8 weeks

  • Body composition in cancer patients general view (In-Body-device)

    0 and 8 weeks

  • Endurance (submaximal treadmill test)

    0 and 8 weeks

  • Functional muscle power test - dynamic elevation test for upper arms

    0 and 8 weeks

  • +5 more secondary outcomes

Study Arms (1)

Exercise intervention

EXPERIMENTAL

The duration of the exercise intervention is eight (8) weeks. There will be guided endurance and muscle power training two (2) time weekly. The participants will also be provided with one training program per week for use at home. Data on training at home and other items of physical activity is recorded in a diary.

Behavioral: Exercise intervention for cancer patients to increase physical activity during chemotherapy

Interventions

The duration of the exercise intervention is eight (8) weeks. There will be guided endurance and muscle power training two (2) time weekly. The participants will also be provided with one training program per week for use at home.

Exercise intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cancer patients in the age of 18-70
  • in the early phase of chemotherapy
  • first line chemotherapy
  • active way of treating cancer
  • solid tumor (breast cancer, prostata cancer, colon cancer and melanoma)
  • Finnish-speaking
  • z=0-1 (no aids)
  • capable travelling to University hospital for 8 weeks twice a week
  • normal or poor physical activity background

You may not qualify if:

  • exercise contraindications, like severe respiratory or circulatory system disease (eg. heart attack \<3)
  • brain or bone metastasis
  • heterogenous group (max 4 patients per cancer diagnose)
  • thrombocytopenia
  • leukocytopenia
  • immuno-oncological treatments
  • really "athlete patients"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University hospital

Turku, 20521, Finland

Location

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2019

First Posted

November 5, 2019

Study Start

February 17, 2020

Primary Completion

April 16, 2020

Study Completion

May 8, 2020

Last Updated

November 2, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations