Heat Therapy to Prevent Deconditioning During Immobilization

NCT05021523 | Completed

• 1 other identifier: F202007002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Animal models suggest that heat stress increases protein content and facilitates the recovery of atrophied muscle after an immobilization period, or following a chemically induced muscle injury in rats. Thus, a recent study in human have reported that daily heat treatments, applied during 10 days of immobilization, reduced the loss of muscle mass. In addition of protecting muscle mass, repeated heat stress may also help to maintain cardiovascular fitness from the onset of injury through passive exposures in the condition that they sufficiently trigger an increase in body temperature, circulation and sweating. This study will investigate the benefits of using heat therapy to prevent deconditioning during immobilization in human.

Conditions

Hot Weather; Adverse Effect; Immobilization, Tonic

Outcome Measures

Primary Outcomes (6)

• Change in maximal strength of the plantar flexors from baseline to post-immobilization

  Maximal voluntary isometric torque of the right leg (plantar flexors) in N.m

  Baseline (week 4) and week 6 (post immobilization)

• Change in maximal strength of the plantar flexors from baseline to post-retraining

  Maximal voluntary isometric torque of the right leg (plantar flexors) in N.m

  Baseline (week 4) and week 8 (post retraining)

• Change in muscle volume of the plantar flexors from baseline to post-immobilization

  MRI to measure muscle volume

  Baseline (week 4) and week 6 (post immobilization)

• Change in muscle volume of the plantar flexors from baseline to post-retraining

  MRI to measure muscle volume

  Baseline (week 4) and week 8 (post retraining)

• Change in muscle protein content from baseline to post-immobilization

  Muscle biopsy

  Baseline (week 4) and week 6 (post immobilization)

• Change in muscle protein content from baseline to post-retraining

  Muscle biopsy

  Baseline (week 4) and week 8 (post retraining)

Secondary Outcomes (10)

• Change in maximal aerobic capacity from baseline to post-immobilization

  Baseline (week 4) and week 6 (post immobilization)

• Change in maximal aerobic capacity from baseline to post-retraining

  Baseline (week 4) and week 8 (post retraining)

• Change in maximal aerobic power from baseline to post-immobilization

  Baseline (week 4) and week 6 (post immobilization)

• Change in maximal aerobic power from baseline to post-retraining

  Baseline (week 4) and week 8 (post retraining)

• Change in blood volume from baseline to post-immobilization

  Baseline (week 4) and week 6 (post immobilization)

Study Arms (2)

HEAT group

EXPERIMENTAL

Participants are doing passive and active heat exposures

Other: Hot ambient conditions exposures; Other: Immobilization

CON group

SHAM COMPARATOR

Participants are doing sham altitude exposures

Other: Immobilization

Interventions

Hot ambient conditions exposures OTHER

Participants rest or exercise for 40min to 1h daily in hot ambient conditions

HEAT group

Immobilization OTHER

Participants are wearing a walking boot (with crutches) for 2 weeks

CON group; HEAT group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 45 yrs old
• Male
• Constant level of activity for at least 2 months before the start of the study
• Fluent English speaker

You may not qualify if:

• Contraindication to physical activity as per the Par-Q questionnaire
• Neural pathology
• Muscular pathology
• Contraindication to the MRI

Sponsors & Collaborators

• Aspetar: lead

Study Sites (1)

Aspetar

Doha, 00000, Qatar

Location

MeSH Terms

Conditions

Immobility Response, Tonic

Interventions

Immobilization

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Motor Activity

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Repeated measure design (pre/post intervention) with an intervention group and a sham group

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: August 25, 2021
• Study Start: November 26, 2020
• Primary Completion: July 12, 2021
• Study Completion: July 12, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)