The Effect of Strength Training and Protein Supplementation in Old Pre-frail Individuals

NCT03723902 | Completed DMC

• 1 other identifier: ST-PF
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effects of a lower-body strength training regime combined with protein supplementation in pre-frail elderly individuals. Participants are randomized to a group performing three weekly sessions of heavy-load strength training for 10 weeks and receiving daily protein supplementation, or a non-training, non-supplemented control group. The endpoints are changes in body composition, the relative changes in different compartments of the quadriceps femoris muscles, and the relationships between changes in muscle mass, muscle thickness, strength, and functional capacity. The investigators hypothesize that 10 weeks of heavy load strength training and protein supplementation will elicit improvements in muscle mass, strength, and functional performance. Moreover, it is hypothesized that improvements in strength will correlate with the improvements in functional performance.

Conditions

Aging

Keywords

Strength training; Pre-frail

Outcome Measures

Primary Outcomes (3)

• Muscle strength of m. Quadriceps Femoris

  Maximal isometric muscle strength of m. quadriceps femoris (maximal voluntary contraction for the knee extensors)

  Change from baseline at 10 weks

• Muscle strength of m. quadriceps femoris

  Maximal dynamic muscle strength of m. quadriceps femoris (knee extension 1 repetition maximum)

  Change from baseline at 10 weeks

• Leg lean mass

  Measured by Dual-energy X-ray Absorptiometry (DXA-scan)

  Change from baseline at 10 weeks

Secondary Outcomes (13)

• Total lean mass

  Change from baseline at 10 weeks

• Fat mass

  Change from baseline at 10 weeks

• Bone mineral density

  Change from baseline at 10 weeks

• m. Vastus Lateralis thickness

  Change from baseline at 10 weeks

• m. Rectus Femoris thickness

  Change from baseline at 10 weeks

Study Arms (2)

Strength training + protein supplement

EXPERIMENTAL

Heavy-load strength training, Protein supplementation

Other: Heavy-load strength training; Dietary Supplement: Protein supplementation

Control

NO INTERVENTION

No intervention

Interventions

Heavy-load strength training OTHER

Three weekly sessions of heavy-load strength training for 10 weeks

Also known as: Resistance exercise

Strength training + protein supplement

Protein supplementation DIETARY_SUPPLEMENT

Daily supplementation of 2 x 17 grams of milk protein

Strength training + protein supplement

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age \> 75
• Short Physical Performance Battery (SPPB) score ≤ 10

You may not qualify if:

• Lactose intolerance
• Milk allergy
• Diseases or musculoskeletal disorders contraindicating training/testing

Sponsors & Collaborators

• Norwegian School of Sport Sciences: lead

Study Sites (1)

Norwegian School of Sport Sciences

Oslo, 0863, Norway

Location

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Truls Raastad, Prof.

  Norwegian School of Sport Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: October 30, 2018
• Study Start: July 1, 2015
• Primary Completion: December 21, 2015
• Study Completion: December 21, 2015
• Last Updated: March 14, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)