## Protocol Section
### Identification Module
**NCT ID:** NCT03275779

**Acronym:** EXFREQ

**Brief Title:** Investigating the Role of Resistance Exercise Frequency in the Regulation of Skeletal Muscle Mass

**Official Title:** Investigating the Role of Resistance Exercise Frequency in the Regulation of Skeletal Muscle Mass

#### Organization Study ID Info
**ID:** ERN_17-0997
#### Organization
**Class:** OTHER
**Full Name:** University of Birmingham
### Status Module
#### Completion Date
**Date:** 2018-12-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-01-05

**Type:** ACTUAL

**Last Update Submit Date:** 2023-01-03

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-12-01

**Type:** ACTUAL

#### Start Date
**Date:** 2018-01-01

**Type:** ACTUAL

**Status Verified Date:** 2022-12

#### Study First Post Date
**Date:** 2017-09-08
**Type:** ACTUAL
**Study First Submit Date:** 2017-08-31
**Study First Submit QC Date:** 2017-09-05
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Maastricht University

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Birmingham

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study will investigate whether manipulating resistance exercise frequency impacts muscle protein synthesis rates. The investigators will test the hypothesise that a higher resistance exercise frequency will result in greater muscle protein synthesis rates than a lower resistance exercise frequency.

**Detailed Description:** Resistance exercise is currently the most effective means of building or maintaining muscle mass. Resistance exercise guidelines generally suggest that those looking to increase muscle mass should train each muscle group once to twice per week. However, it has been proposed that it may be of greater benefit to train a muscle group with a higher frequency (i.e., four to six times per week) than currently suggested. If true, completing the same total volume of resistance exercise in more frequent, smaller bouts could prove to be a more beneficial strategy to optimally build or maintain muscle mass.

Therefore, this study will investigate whether manipulating resistance exercise frequency impacts cumulative muscle protein synthesis rates in young individuals. Participants will undergo a 7 day period of habitual activity before completing the same total volume of resistance exercise as either; i) one isolated bout (low frequency) or ii) five smaller bouts (high frequency) over a period of 7 days.

### Conditions Module

**Conditions:**

- Physical Activity

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 9

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants complete 7 days of habitual physical activity followed by a 7 day period where participants complete a single bout of unilateral resistance exercise.

**Intervention Names:**

- Behavioral: Low Frequency Condition

**Label:** Low Frequency Condition

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants complete 7 days of habitual physical activity followed by a 7 day period where participants complete the same total volume of resistance exercise as the low frequency condition as five smaller bouts of unilateral resistance exercise.

**Intervention Names:**

- Behavioral: High Frequency Condition

**Label:** High Frequency Condition

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Low Frequency Condition

**Description:** Young, untrained participants complete 7 days of habitual physical activity followed by a 7 day period where participants complete a single bout of unilateral resistance exercise.

**Name:** Low Frequency Condition

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- High Frequency Condition

**Description:** Young, untrained participants complete 7 days of habitual physical activity followed by a 7 day period where participants complete the same total volume of resistance exercise as the low frequency condition as five smaller bouts of unilateral resistance exercise.

**Name:** High Frequency Condition

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** The change in muscle protein synthesis rates (FSR %/day) from baseline will be determined between the low and high frequency conditions at days 10 and 15 using deuterium oxide (D2O).

**Measure:** Change in muscle protein synthesis (FSR %/day)

**Time Frame:** At day 10 and 15.

#### Secondary Outcomes

**Description:** The change in acute satellite cell response will be determined in muscle samples following low and high frequency resistance exercise at days 10 and 15.

**Measure:** Change in satellite cell response

**Time Frame:** At day 10 and 15.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Body mass index (18.5-29.99 kg/m2)
* Untrained - defined as: Perform activities of daily living and recreation but have completed no regular lower body resistance-type exercise (e.g., weight training) activity in the last year.
* Good general health

Exclusion Criteria:

* Lidocaine allergy
* Hypertension (≥140/90 mmHg)
* Current participation in another clinical study
* Previous participation in this study
* Bleeding disorder/s
* Current or recent smoker
* Vegetarian or vegan
* Past history of substance abuse and/or taking prescription or non-prescription medication (e.g., beta-blockers, insulin or thyroxine) or supplements that may influence normal metabolic responses.

**Gender Based:** True

**Gender Description:** Participants must be male.

**Healthy Volunteers:** True

**Maximum Age:** 35 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Birmingham

**Country:** United Kingdom

**Facility:** School of Sport Exercise and Rehabilitation Sciences, University of Birmingham

**State:** West Midlands

**Zip:** B15 2TT

#### Overall Officials

**Official 1:**

**Affiliation:** University of Birmingham

**Name:** Gareth Wallis, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
