EXPLORING the IMPACT of SUPERVISED PHYSICAL ACTIVITY INTERVENTION on CACHECTIC CANCER PATIENTS: a PRELIMINARY STUDY

NCT06651125 | Completed

• 1 other identifier: APACAVIR
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this project is to observe the benefits induced by physical activity during a supervised adapted physical activity program at SPORMED. Methodology: By agreeing to participate in this study, participation in a supervised adapted physical activity (APA) program at SPORMED and undergoing a series of evaluations will be required. At the start of the adapted physical activity program (T0), two APA sessions per week will be carried out for eight weeks. These group sessions, involving four participants, last 1 hour and are divided into 30 minutes of aerobic work on an ergometer followed by 30 minutes of muscle strengthening of the four limbs and core exercises, with or without small equipment. There is also the option to add a 45-minute balneotherapy session once a week, if desired and no contraindications are present. At the end of the eight weeks (T1), a follow-up phase begins, consisting of one APA session per week for another eight weeks. The session will be identical to the previously described sessions and can also be complemented by a balneotherapy session. The APA program will conclude after these 12 weeks (T2). A total of 24 indoor sessions will be offered, which can be supplemented by 12 balneotherapy sessions. Attendance at the sessions will be recorded. Additionally, a series of evaluations will take place at T0, T1, and T2. These include physical and anthropometric assessments at SPORMED lasting approximately 30 minutes. They involve weight and body composition evaluation (2 minutes), height measurement (1 minute), waist and hip circumference measurements using a tape measure (2 minutes). Next, an upper limb strength test will be conducted, involving three maximal contractions during a handgrip test with 30-second rest intervals (2 minutes), followed by a lower limb strength test, which involves performing as many sit-to-stand repetitions from a chair with a backrest and without armrests as possible in 30 seconds (30 seconds). Then, a balance test, including bipodal and unipodal stance (30 seconds on both feet, followed by each foot individually), will be performed, and finally, a 6-minute walking test, during which the longest possible distance must be covered (without running) in 6 minutes (6 minutes, with the option to stop if necessary). Additionally, four self-assessment questionnaires on quality of life, fatigue, physical activity level, and food consumption must be completed at home (about 20 to 30 minutes).

Conditions

Cancer Cachexia

Keywords

Cancer Cachexia; Exercise; Adapted Physical Activity; Resistance training; Endurance training; Body composition

Outcome Measures

Primary Outcomes (3)

• Attrition rate

  Attrition rate was the number of patients who completed the baseline and follow-up assessments versus the number of patients who completed initial assessments and started the program

  Through study completion, an average of 3 months

• Compliance rate

  Compliance rate was the number of sessions completed out of the number of sessions prescribed

  Through study completion, an average of 3 months

• Serious adverse events

  Serious adverse events occurring during the exercise program

  Through study completion, an average of 3 months

Secondary Outcomes (10)

• Nutritional status

  Through study completion, an average of 3 months

• Body weight

  Through study completion, an average of 3 months

• Fat mass

  Through study completion, an average of 3 months

• Lean mass

  Through study completion, an average of 3 months

• Physical activity level

  Through study completion, an average of 3 months

Study Arms (1)

Cachectic Cancer Patients

EXPERIMENTAL

Other: Adapted Physical Activity

Interventions

Adapted Physical Activity OTHER

Patients in the Adapted Physical Activity arm realized a 12-weeks supervised exercise program. The supervised PA intervention consisted of two sessions per week. Each session lasted one hour and was divided into 30 minutes of aerobic exercise using an ergometer (treadmill and/or bicycle), followed by 30 minutes of resistance exercises involving major muscle groups, with or without small equipment such as dumbbells, resistance bands, and balls. The exercise regimen was carried out at an intensity ranging from 50% to 70% of the heart rate reserve, with a rate of perceived exertion (RPE) set at 4 on a Borg scale of 0 to 10. A total of 24 sessions were planned. There was also the option to incorporate a 45-minute session of moderate-intensity water aerobics into the weekly routine.

Cachectic Cancer Patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years
• Diagnosis of cancer cachexia
• Able to participate in exercise program
• Registered with the French health insurance system
• Understanding and speaking French

You may not qualify if:

• Medical contraindications for exercise
• No report of weight changes in the last 6 months
• Disabilities to understand the study instructions

Sponsors & Collaborators

• University of Rennes 2: lead

Study Sites (1)

SPORMED

Rennes, Brittany Region, 35000, France

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 21, 2024
• Study Start: November 1, 2020
• Primary Completion: April 11, 2023
• Study Completion: April 11, 2023
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)